Trial Outcomes & Findings for EXERCISING TOGETHER for Couples Coping With Cancer (NCT NCT03630354)
NCT ID: NCT03630354
Last Updated: 2025-07-01
Results Overview
Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's fatigue in the past 7 days using the Functional Assessment in Chronic Illness Therapy (FACIT) fatigue questionnaire. This instrument has 13 items, and possible scores from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue. Reported values reflect the estimated slope over 6-months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
496 participants
Primary outcome timeframe
Baseline, 3, 6 and 12 months
Results posted on
2025-07-01
Participant Flow
Community-dwelling couples were recruited between January 2019 and October 2022. The first couple was enrolled on January 18, 2019 and the last was couple was enrolled on October 26, 2022.
Of 269 consented couples, 248 couples (496 individuals: 248 survivors + 248 partners) met inclusion criteria and were randomized to an intervention group.
Participant milestones
| Measure |
Arm I (Supervised Exercise Together)
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention: Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
164
|
170
|
162
|
|
Overall Study
COMPLETED
|
148
|
148
|
126
|
|
Overall Study
NOT COMPLETED
|
16
|
22
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Survivors only
Baseline characteristics by cohort
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention: Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.46 • n=82 Participants • Partners only
|
62.7 years
STANDARD_DEVIATION 10.7 • n=85 Participants • Partners only
|
62.6 years
STANDARD_DEVIATION 65.5 • n=81 Participants • Partners only
|
63.4 years
STANDARD_DEVIATION 10.1 • n=248 Participants • Partners only
|
|
Sex: Female, Male
Female
|
41 Participants
n=82 Participants • Partners only
|
43 Participants
n=85 Participants • Partners only
|
39 Participants
n=81 Participants • Partners only
|
123 Participants
n=248 Participants • Partners only
|
|
Sex: Female, Male
Male
|
41 Participants
n=82 Participants • Partners only
|
42 Participants
n=85 Participants • Partners only
|
42 Participants
n=81 Participants • Partners only
|
125 Participants
n=248 Participants • Partners only
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=82 Participants • Partners only
|
1 Participants
n=85 Participants • Partners only
|
4 Participants
n=81 Participants • Partners only
|
8 Participants
n=248 Participants • Partners only
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=82 Participants • Partners only
|
84 Participants
n=85 Participants • Partners only
|
75 Participants
n=81 Participants • Partners only
|
238 Participants
n=248 Participants • Partners only
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=82 Participants • Partners only
|
0 Participants
n=85 Participants • Partners only
|
2 Participants
n=81 Participants • Partners only
|
2 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=82 Participants • Partners only
|
0 Participants
n=85 Participants • Partners only
|
0 Participants
n=81 Participants • Partners only
|
0 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=82 Participants • Partners only
|
3 Participants
n=85 Participants • Partners only
|
4 Participants
n=81 Participants • Partners only
|
9 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=82 Participants • Partners only
|
1 Participants
n=85 Participants • Partners only
|
0 Participants
n=81 Participants • Partners only
|
2 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=82 Participants • Partners only
|
0 Participants
n=85 Participants • Partners only
|
1 Participants
n=81 Participants • Partners only
|
3 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
White
|
75 Participants
n=82 Participants • Partners only
|
78 Participants
n=85 Participants • Partners only
|
70 Participants
n=81 Participants • Partners only
|
223 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=82 Participants • Partners only
|
2 Participants
n=85 Participants • Partners only
|
3 Participants
n=81 Participants • Partners only
|
7 Participants
n=248 Participants • Partners only
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=82 Participants • Partners only
|
1 Participants
n=85 Participants • Partners only
|
3 Participants
n=81 Participants • Partners only
|
4 Participants
n=248 Participants • Partners only
|
|
Region of Enrollment
United States
|
82 Participants
n=82 Participants • Partners only
|
85 Participants
n=85 Participants • Partners only
|
81 Participants
n=81 Participants • Partners only
|
248 Participants
n=248 Participants • Partners only
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Active Engagement subscale from the Relationship Focused Coping Scale. The subscale assesses the degree with which couples practice active engagement by responding to five items on a Likert scale from 1 (never) to 5 (very often). Scores range from 5 to 25, with higher scores indicating more active engagement. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Dyadic Coping - Active Engagement
Survivor: Baseline-6mo
|
-0.45 score on a scale per 6 months
Interval -1.16 to 0.27
|
0.81 score on a scale per 6 months
Interval 0.11 to 1.5
|
0.07 score on a scale per 6 months
Interval -0.68 to 0.83
|
|
Dyadic Coping - Active Engagement
Survivor: 6mo-12mo
|
-0.35 score on a scale per 6 months
Interval -1.01 to 0.3
|
-0.61 score on a scale per 6 months
Interval -1.26 to 0.03
|
-0.08 score on a scale per 6 months
Interval -0.79 to 0.63
|
|
Dyadic Coping - Active Engagement
Partner: Baseline-6mo
|
0.05 score on a scale per 6 months
Interval -0.61 to 0.71
|
-0.08 score on a scale per 6 months
Interval -0.72 to 0.57
|
-0.91 score on a scale per 6 months
Interval -1.62 to -0.19
|
|
Dyadic Coping - Active Engagement
Partner: 6mo-12mo
|
-0.52 score on a scale per 6 months
Interval -1.2 to 0.16
|
-0.14 score on a scale per 6 months
Interval -0.81 to 0.54
|
-0.35 score on a scale per 6 months
Interval -1.09 to 0.39
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Protective Buffering Subscale from the Relationship Focused Coping Scale. Assesses the degree with which couples practice protective buffering by responding to six items using a Likert scale of 1 (never) to 5 (very often). Scores range from 6 to 30 with higher scores indicating more protective buffering. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Dyadic Coping - Protective Buffering
Survivor: Baseline-6mo
|
-0.48 Score on a scale per 6 months
Interval -1.24 to 0.29
|
-0.18 Score on a scale per 6 months
Interval -0.93 to 0.57
|
-0.13 Score on a scale per 6 months
Interval -0.93 to 0.66
|
|
Dyadic Coping - Protective Buffering
Survivor: 6mo-12mo
|
-0.21 Score on a scale per 6 months
Interval -0.91 to 0.5
|
-0.46 Score on a scale per 6 months
Interval -1.16 to 0.24
|
-0.57 Score on a scale per 6 months
Interval -1.34 to 0.2
|
|
Dyadic Coping - Protective Buffering
Partner: Baseline-6mo
|
0.36 Score on a scale per 6 months
Interval -0.39 to 1.1
|
-0.09 Score on a scale per 6 months
Interval -0.81 to 0.62
|
0.36 Score on a scale per 6 months
Interval -0.44 to 1.15
|
|
Dyadic Coping - Protective Buffering
Partner: 6mo-12mo
|
-0.04 Score on a scale per 6 months
Interval -0.75 to 0.68
|
-0.20 Score on a scale per 6 months
Interval -0.91 to 0.51
|
-0.27 Score on a scale per 6 months
Interval -1.07 to 0.54
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the 7-item Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering 7 questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree). Scores range from 0-21 with higher scores indicating better dyadic adjustment. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Emotional Intimacy
Survivor: Baseline-6mo
|
3.37 Score on a scale per 6 months
Interval 0.78 to 5.97
|
2.61 Score on a scale per 6 months
Interval 0.06 to 5.15
|
2.97 Score on a scale per 6 months
Interval 0.2 to 5.73
|
|
Emotional Intimacy
Survivor: 6mo-12mo
|
-2.87 Score on a scale per 6 months
Interval -5.84 to 0.1
|
-2.30 Score on a scale per 6 months
Interval -5.26 to 0.67
|
-1.33 Score on a scale per 6 months
Interval -4.66 to 2.01
|
|
Emotional Intimacy
Partner: Baseline-6mo
|
.98 Score on a scale per 6 months
Interval -1.25 to 3.2
|
1.90 Score on a scale per 6 months
Interval -0.24 to 4.05
|
-.99 Score on a scale per 6 months
Interval -3.42 to 1.43
|
|
Emotional Intimacy
Partner: 6mo-12mo
|
-2.63 Score on a scale per 6 months
Interval -5.01 to -0.26
|
-.43 Score on a scale per 6 months
Interval -2.73 to 1.88
|
1.96 Score on a scale per 6 months
Interval -0.64 to 4.56
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced.
Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in sexual behaviors answering two questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 2 to 8 with higher scores indicating higher physical intimacy.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=151 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=161 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=138 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Physical Intimacy - Engagement in Sex
Survivor: Baseline-6mo
|
0.08 Score on a scale per 6 months
Interval -0.23 to 0.4
|
-0.04 Score on a scale per 6 months
Interval -0.34 to 0.26
|
-0.07 Score on a scale per 6 months
Interval -0.42 to 0.29
|
|
Physical Intimacy - Engagement in Sex
Survivor: 6mo-12mo
|
-0.02 Score on a scale per 6 months
Interval -0.29 to 0.24
|
0.19 Score on a scale per 6 months
Interval -0.07 to 0.44
|
-0.02 Score on a scale per 6 months
Interval -0.32 to 0.28
|
|
Physical Intimacy - Engagement in Sex
Partner: Baseline-6mo
|
0.10 Score on a scale per 6 months
Interval -0.2 to 0.39
|
0.16 Score on a scale per 6 months
Interval -0.11 to 0.43
|
-0.08 Score on a scale per 6 months
Interval -0.41 to 0.24
|
|
Physical Intimacy - Engagement in Sex
Partner: 6mo-12mo
|
-0.12 Score on a scale per 6 months
Interval -0.41 to 0.17
|
-0.23 Score on a scale per 6 months
Interval -0.5 to 0.05
|
0.03 Score on a scale per 6 months
Interval -0.3 to 0.35
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12-monthsPopulation: This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced.
Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in affectionate behaviors answering four questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 4 to 16 with higher scores indicating higher physical intimacy.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=161 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=167 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=152 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Physical Intimacy - Engagement in Affectionate Behaviors
Survivor: Baseline-6mo
|
0.37 Score on a scale per 6 months
Interval -0.18 to 0.92
|
0.08 Score on a scale per 6 months
Interval -0.45 to 0.6
|
0.19 Score on a scale per 6 months
Interval -0.41 to 0.79
|
|
Physical Intimacy - Engagement in Affectionate Behaviors
Survivor: 6mo-12mo
|
-0.04 Score on a scale per 6 months
Interval -0.57 to 0.49
|
0.02 Score on a scale per 6 months
Interval -0.5 to 0.54
|
0.15 Score on a scale per 6 months
Interval -0.45 to 0.74
|
|
Physical Intimacy - Engagement in Affectionate Behaviors
Partner: Baseline-6mo
|
0.30 Score on a scale per 6 months
Interval -0.22 to 0.82
|
0.29 Score on a scale per 6 months
Interval -0.22 to 0.79
|
0.23 Score on a scale per 6 months
Interval -0.36 to 0.82
|
|
Physical Intimacy - Engagement in Affectionate Behaviors
Partner: 6mo-12mo
|
-0.37 Score on a scale per 6 months
Interval -0.93 to 0.18
|
-0.18 Score on a scale per 6 months
Interval -0.72 to 0.36
|
-0.15 Score on a scale per 6 months
Interval -0.79 to 0.5
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Emotional-Intimacy Disruptive Behavior Scale. Patients report the extent to which they engage in 8 behaviors using a scale from 1 (rarely or none of the time) to 4 (most or all of the time). Scores range from 8-32 where higher scores indicate more concealment Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Concealment of Symptoms
Survivor: Baseline-6mo
|
-.24 Score on a scale per 6 months
Interval -0.88 to 0.4
|
.07 Score on a scale per 6 months
Interval -0.56 to 0.69
|
-.82 Score on a scale per 6 months
Interval -1.52 to -0.11
|
|
Concealment of Symptoms
Survivor: 6mo-12mo
|
-.23 Score on a scale per 6 months
Interval -0.82 to 0.36
|
-.18 Score on a scale per 6 months
Interval -0.77 to 0.41
|
.53 Score on a scale per 6 months
Interval -0.14 to 1.2
|
|
Concealment of Symptoms
Partner: Baseline-6mo
|
-.33 Score on a scale per 6 months
Interval -0.98 to 0.33
|
-.44 Score on a scale per 6 months
Interval -1.07 to 0.22
|
-.70 Score on a scale per 6 months
Interval -1.41 to 0.01
|
|
Concealment of Symptoms
Partner: 6mo-12mo
|
.63 Score on a scale per 6 months
Interval 0.04 to 1.23
|
-.23 Score on a scale per 6 months
Interval -0.82 to 0.36
|
-.11 Score on a scale per 6 months
Interval -0.76 to 0.55
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the degree of agreement (change or difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate "no pain" and high values represent "pain as bad as you can imagine". Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Pain Incongruence - Pain Intensity
Baseline-6mo
|
.17 Score on a scale per 6 months
Interval -0.13 to 0.47
|
.08 Score on a scale per 6 months
Interval -0.22 to 0.37
|
.16 Score on a scale per 6 months
Interval -0.16 to 0.48
|
|
Pain Incongruence - Pain Intensity
6mo-12mo
|
-.08 Score on a scale per 6 months
Interval -0.38 to 0.21
|
.16 Score on a scale per 6 months
Interval -0.14 to 0.44
|
.16 Score on a scale per 6 months
Interval -0.16 to 0.48
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate "no pain" and high values represent "pain as bad as you can imagine". Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Pain Incongruence - Pain Interference
Baseline-6mo
|
-.38 Score on a scale per 6 months
Interval -0.7 to -0.07
|
.01 Score on a scale per 6 months
Interval -0.3 to 0.32
|
-.05 Score on a scale per 6 months
Interval -0.38 to 0.29
|
|
Pain Incongruence - Pain Interference
6mo-12mo
|
.27 Score on a scale per 6 months
Interval -0.04 to 0.58
|
-.09 Score on a scale per 6 months
Interval -0.39 to 0.21
|
.16 Score on a scale per 6 months
Interval -0.17 to 0.5
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's fatigue in the past 7 days using the Functional Assessment in Chronic Illness Therapy (FACIT) fatigue questionnaire. This instrument has 13 items, and possible scores from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Fatigue Incongruence
Baseline-6mo
|
1.02 Score on a scale per 6 months
Interval -0.28 to 2.32
|
-1.24 Score on a scale per 6 months
Interval -2.5 to 0.03
|
-.41 Score on a scale per 6 months
Interval -1.8 to 0.98
|
|
Fatigue Incongruence
6mo-12mo
|
-1.20 Score on a scale per 6 months
Interval -2.49 to 0.1
|
-.03 Score on a scale per 6 months
Interval -1.3 to 1.24
|
-.67 Score on a scale per 6 months
Interval -2.08 to 0.74
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's physical function in the past 4 weeks using the perceived physical function subscale of the SF-36 medical outcomes survey. Possible scores range from 0-100. Low scores indicate a high degree of limitation in performing physical activities, whereas high scores represent no limitations in performing physical activities due to health. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Perceived Physical Function Incongruence
Baseline-6mo
|
.41 Score on a scale per 6 months
Interval -0.87 to 1.68
|
-.66 Score on a scale per 6 months
Interval -1.9 to 0.59
|
-.83 Score on a scale per 6 months
Interval -2.19 to 0.53
|
|
Perceived Physical Function Incongruence
6mo-12mo
|
1.33 Score on a scale per 6 months
Interval 0.05 to 2.61
|
.62 Score on a scale per 6 months
Interval -0.64 to 1.88
|
1.29 Score on a scale per 6 months
Interval -0.1 to 2.69
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by bone-free lean (kg) for the whole body determined from a whole body dual energy x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Body Composition - Bone-free Lean Mass
Survivor: Baseline-6mo
|
3.38 kg per 6 months
Interval 2.88 to 3.88
|
3.19 kg per 6 months
Interval 2.71 to 3.67
|
3.19 kg per 6 months
Interval 2.61 to 3.77
|
|
Body Composition - Bone-free Lean Mass
Survivor: 6mo-12mo
|
-0.89 kg per 6 months
Interval -1.38 to -0.39
|
-0.60 kg per 6 months
Interval -1.06 to -0.14
|
-1.04 kg per 6 months
Interval -1.59 to -0.49
|
|
Body Composition - Bone-free Lean Mass
Partner: Baseline-6mo
|
3.20 kg per 6 months
Interval 2.73 to 3.67
|
3.32 kg per 6 months
Interval 2.86 to 3.79
|
3.17 kg per 6 months
Interval 2.62 to 3.72
|
|
Body Composition - Bone-free Lean Mass
Partner: 6mo-12mo
|
-1.43 kg per 6 months
Interval -1.96 to -0.9
|
-1.03 kg per 6 months
Interval -1.53 to -0.52
|
-1.05 kg per 6 months
Interval -1.64 to -0.46
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by fat mas (kg) for the whole body determined from a whole body dual x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Body Composition - Fat Mass
Survivor: Baseline-6mo
|
-3.32 kg per 6 months
Interval -3.94 to -2.71
|
-3.50 kg per 6 months
Interval -4.1 to -2.91
|
-2.77 kg per 6 months
Interval -3.49 to -2.05
|
|
Body Composition - Fat Mass
Survivor: 6mo-12mo
|
1.38 kg per 6 months
Interval 0.8 to 1.96
|
1.05 kg per 6 months
Interval 0.52 to 1.59
|
0.53 kg per 6 months
Interval -0.12 to 1.18
|
|
Body Composition - Fat Mass
Partner: Baseline-6mo
|
-3.63 kg per 6 months
Interval -4.17 to -3.09
|
-3.36 kg per 6 months
Interval -3.9 to -2.83
|
-3.16 kg per 6 months
Interval -3.79 to -2.52
|
|
Body Composition - Fat Mass
Partner: 6mo-12mo
|
0.22 kg per 6 months
Interval -0.56 to 0.99
|
0.87 kg per 6 months
Interval 0.14 to 1.6
|
0.25 kg per 6 months
Interval -0.62 to 1.11
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by serum fasting total cholesterol.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiovascular Health: Serum Cholesterol
Survivor: Baseline-6mo
|
-4.23 mg/dL per 6 months
Interval -10.56 to 2.09
|
2.74 mg/dL per 6 months
Interval -3.34 to 8.81
|
-6.45 mg/dL per 6 months
Interval -13.77 to 0.88
|
|
Cardiovascular Health: Serum Cholesterol
Survivor: 6mo-12mo
|
3.77 mg/dL per 6 months
Interval -3.36 to 10.89
|
-0.71 mg/dL per 6 months
Interval -7.11 to 5.7
|
2.68 mg/dL per 6 months
Interval -4.88 to 10.24
|
|
Cardiovascular Health: Serum Cholesterol
Partner: Baseline-6mo
|
-2.89 mg/dL per 6 months
Interval -9.71 to 3.92
|
-2.18 mg/dL per 6 months
Interval -11.1 to 2.74
|
-2.91 mg/dL per 6 months
Interval -10.7 to 4.87
|
|
Cardiovascular Health: Serum Cholesterol
Partner: 6mo-12mo
|
-1.30 mg/dL per 6 months
Interval -8.4 to 5.79
|
-3.11 mg/dL per 6 months
Interval -9.94 to 3.72
|
0.85 mg/dL per 6 months
Interval -6.86 to 8.56
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by serum triglycerides.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiovascular Health: Serum Triglycerides
Survivor: Baseline-6mo
|
-9.86 mg/dL per 6 months
Interval -22.47 to 2.65
|
7.00 mg/dL per 6 months
Interval -5.01 to 19.0
|
-9.76 mg/dL per 6 months
Interval -23.99 to 4.46
|
|
Cardiovascular Health: Serum Triglycerides
Survivor: 6mo-12mo
|
4.79 mg/dL per 6 months
Interval -10.48 to 20.06
|
-0.15 mg/dL per 6 months
Interval -13.74 to 13.44
|
12.02 mg/dL per 6 months
Interval -3.97 to 28.0
|
|
Cardiovascular Health: Serum Triglycerides
Partner: Baseline-6mo
|
-4.53 mg/dL per 6 months
Interval -17.3 to 8.24
|
11.13 mg/dL per 6 months
Interval -1.83 to 24.09
|
2.64 mg/dL per 6 months
Interval -11.92 to 17.21
|
|
Cardiovascular Health: Serum Triglycerides
Partner: 6mo-12mo
|
-8.44 mg/dL per 6 months
Interval -23.29 to 6.42
|
-15.28 mg/dL per 6 months
Interval -29.55 to -1.01
|
16.41 mg/dL per 6 months
Interval 0.29 to 32.53
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) - used to assess insulin sensitivity and predict the risk of type 2 diabetes and other metabolic disorders. Calculated as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant, 405. Scores generally range from 0.5 to 2.5, with lower scores indicating better insulin sensitivity and higher scores suggesting higher insulin resistance. A HOMA-IR score of 1.0 or less is considered optimal, while scores above 2.9 may indicate significant insulin resistance. Reported values reflect the estimated slope over 6-months. (Glucose mg/dL \* insulin uIU/ml) / 405
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiovascular Health: Insulin Resistance
Survivor: Baseline-6mo
|
-0.06 Score on a scale per 6 months
Interval -0.17 to 0.06
|
-0.02 Score on a scale per 6 months
Interval -0.13 to 0.09
|
-0.01 Score on a scale per 6 months
Interval -0.14 to 0.12
|
|
Cardiovascular Health: Insulin Resistance
Survivor: 6mo-12mo
|
-0.05 Score on a scale per 6 months
Interval -0.19 to 0.01
|
0.01 Score on a scale per 6 months
Interval -0.13 to 0.14
|
-0.03 Score on a scale per 6 months
Interval -0.19 to 0.12
|
|
Cardiovascular Health: Insulin Resistance
Partner: Baseline-6mo
|
0.01 Score on a scale per 6 months
Interval -0.1 to 0.12
|
-0.13 Score on a scale per 6 months
Interval -0.24 to -0.02
|
0.03 Score on a scale per 6 months
Interval -0.1 to 0.16
|
|
Cardiovascular Health: Insulin Resistance
Partner: 6mo-12mo
|
-0.01 Score on a scale per 6 months
Interval -0.15 to 0.13
|
0.13 Score on a scale per 6 months
Interval 0.0 to 0.26
|
-0.08 Score on a scale per 6 months
Interval -0.24 to 0.07
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiovascular Health: Resting Systolic Blood Pressure
Survivor: Baseline-6mo
|
-4.91 mmHg per 6 months
Interval -7.81 to -2.0
|
-5.50 mmHg per 6 months
Interval -8.31 to -2.69
|
-3.34 mmHg per 6 months
Interval -6.67 to 0.0
|
|
Cardiovascular Health: Resting Systolic Blood Pressure
Survivor: 6mo-12mo
|
0.83 mmHg per 6 months
Interval -2.46 to 4.12
|
3.46 mmHg per 6 months
Interval 0.41 to 6.51
|
2.38 mmHg per 6 months
Interval -1.25 to 6.02
|
|
Cardiovascular Health: Resting Systolic Blood Pressure
Partner: Baseline-6mo
|
-5.92 mmHg per 6 months
Interval -9.16 to -2.67
|
-7.58 mmHg per 6 months
Interval -10.8 to -4.34
|
-7.93 mmHg per 6 months
Interval -11.67 to -4.19
|
|
Cardiovascular Health: Resting Systolic Blood Pressure
Partner: 6mo-12mo
|
-0.41 mmHg per 6 months
Interval -3.58 to 2.76
|
-7.02 mmHg per 6 months
Interval -12.37 to -1.67
|
-1.56 mmHg per 6 months
Interval -5.14 to 2.03
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Cardiovascular Health: Resting Diastolic Blood Pressure
Survivor: Baseline-6mo
|
-2.07 mmHg per 6 months
Interval -3.84 to -0.29
|
-4.10 mmHg per 6 months
Interval -5.81 to -2.38
|
-2.34 mmHg per 6 months
Interval -4.4 to -0.29
|
|
Cardiovascular Health: Resting Diastolic Blood Pressure
Survivor: 6mo-12mo
|
1.42 mmHg per 6 months
Interval -0.83 to 3.67
|
1.14 mmHg per 6 months
Interval -0.95 to 3.22
|
1.48 mmHg per 6 months
Interval -1.01 to 3.97
|
|
Cardiovascular Health: Resting Diastolic Blood Pressure
Partner: Baseline-6mo
|
-3.26 mmHg per 6 months
Interval -5.29 to -1.23
|
-4.93 mmHg per 6 months
Interval -6.96 to -2.9
|
-2.50 mmHg per 6 months
Interval -4.87 to -0.13
|
|
Cardiovascular Health: Resting Diastolic Blood Pressure
Partner: 6mo-12mo
|
-0.58 mmHg per 6 months
Interval -2.65 to 1.49
|
-1.30 mmHg per 6 months
Interval -3.31 to 0.72
|
-2.26 mmHg per 6 months
Interval -4.6 to 0.09
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Inflammation-hsCRP
Survivor: Baseline-6mo
|
-0.11 mg/L per 6 months
Interval -0.34 to 0.13
|
0.09 mg/L per 6 months
Interval -0.32 to 0.14
|
-0.05 mg/L per 6 months
Interval -0.22 to 0.31
|
|
Inflammation-hsCRP
Survivor: 6mo-12mo
|
-0.12 mg/L per 6 months
Interval -0.36 to 0.12
|
-0.20 mg/L per 6 months
Interval -0.43 to 0.02
|
0.13 mg/L per 6 months
Interval -0.39 to 0.13
|
|
Inflammation-hsCRP
Partner: Baseline-6mo
|
0.01 mg/L per 6 months
Interval -0.34 to 0.13
|
-0.11 mg/L per 6 months
Interval -0.32 to 0.1
|
-0.04 mg/L per 6 months
Interval -0.29 to 0.22
|
|
Inflammation-hsCRP
Partner: 6mo-12mo
|
-0.12 mg/L per 6 months
Interval -0.4 to 0.17
|
-0.13 mg/L per 6 months
Interval -0.4 to 0.15
|
-0.03 mg/L per 6 months
Interval -0.34 to 0.29
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Inflammation-TNF Alpha
Survivor: Baseline-6mo
|
-0.01 pg/mL per 6 months
Interval -0.05 to 0.03
|
-0.02 pg/mL per 6 months
Interval -0.05 to 0.02
|
-0.03 pg/mL per 6 months
Interval -0.08 to 0.01
|
|
Inflammation-TNF Alpha
Survivor: 6mo-12mo
|
-0.01 pg/mL per 6 months
Interval -0.06 to 0.04
|
-0.02 pg/mL per 6 months
Interval -0.07 to 0.03
|
-0.01 pg/mL per 6 months
Interval -0.06 to 0.05
|
|
Inflammation-TNF Alpha
Partner: Baseline-6mo
|
-0.02 pg/mL per 6 months
Interval -0.06 to 0.02
|
-0.02 pg/mL per 6 months
Interval -0.06 to 0.02
|
0.00 pg/mL per 6 months
Interval -0.05 to 0.05
|
|
Inflammation-TNF Alpha
Partner: 6mo-12mo
|
0.00 pg/mL per 6 months
Interval -0.05 to 0.06
|
0.00 pg/mL per 6 months
Interval -0.05 to 0.06
|
0.03 pg/mL per 6 months
Interval -0.3 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Objective Physical Function
Partner: Baseline-6mo
|
0.15 Score on a scale per 6 months
Interval -0.14 to 0.43
|
0.82 Score on a scale per 6 months
Interval 0.54 to 1.11
|
0.73 Score on a scale per 6 months
Interval 0.41 to 1.06
|
|
Objective Physical Function
Partner: 6mo-12mo
|
0.11 Score on a scale per 6 months
Interval -0.13 to 0.34
|
-0.18 Score on a scale per 6 months
Interval -0.41 to 0.05
|
-0.11 Score on a scale per 6 months
Interval -0.38 to 0.16
|
|
Objective Physical Function
Survivor: Baseline-6mo
|
0.75 Score on a scale per 6 months
Interval 0.46 to 1.04
|
0.86 Score on a scale per 6 months
Interval 0.6 to 1.17
|
0.73 Score on a scale per 6 months
Interval 0.41 to 1.06
|
|
Objective Physical Function
Survivor: 6mo-12mo
|
-0.03 Score on a scale per 6 months
Interval -0.27 to 0.22
|
-0.07 Score on a scale per 6 months
Interval -0.3 to 0.15
|
-0.30 Score on a scale per 6 months
Interval -0.57 to -0.03
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.
Measures QOL in cancer patients including subscales of physical functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=82 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=85 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=81 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Quality of Life (QOL): QLQ-C30 - Physical Functioning
Survivor: Baseline-6mo
|
2.12 Score on a scale per 6 months
Interval 0.13 to 4.11
|
1.23 Score on a scale per 6 months
Interval -0.7 to 3.17
|
1.26 Score on a scale per 6 months
Interval -0.85 to 3.37
|
|
Quality of Life (QOL): QLQ-C30 - Physical Functioning
Survivor: 6mo-12mo
|
-1.44 Score on a scale per 6 months
Interval -3.56 to 0.68
|
-0.30 Score on a scale per 6 months
Interval -2.4 to 1.8
|
1.74 Score on a scale per 6 months
Interval -0.63 to 4.1
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 monthsPopulation: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.
Measures QOL in cancer patients including subscales of emotional functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=82 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=85 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=81 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Quality of Life (QOL): QLQ-C30 - Emotional Functioning
Survivor: Baseline-6mo
|
4.18 Score on a scale per 6 months
Interval 0.94 to 7.42
|
1.82 Score on a scale per 6 months
Interval -1.36 to 4.98
|
4.67 Score on a scale per 6 months
Interval 1.26 to 8.09
|
|
Quality of Life (QOL): QLQ-C30 - Emotional Functioning
Survivor: 6mo-12mo
|
-0.34 Score on a scale per 6 months
Interval -2.22 to 2.64
|
-0.39 Score on a scale per 6 months
Interval -3.33 to 2.56
|
-1.99 Score on a scale per 6 months
Interval -5.3 to 1.31
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: This measure had a significant amount of missing data for partners (due to a survey logic error) so the total sample size is reduced.
The SF-36 measures quality of life using 8 subscales: perceived physical function, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. All subscales have possible scores from 0-100, with items from each subscale averaged together. Low scores indicate worse physical functioning, while higher scores indicate better physical functioning.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=132 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=135 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=124 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Quality of Life (QOL): SF-36 Physical Function Subscale
Survivor: Baseline-6mo
|
1.73 Score on a scale per 6 months
Interval 0.55 to 2.91
|
2.47 Score on a scale per 6 months
Interval 1.33 to 3.62
|
0.96 Score on a scale per 6 months
Interval -0.28 to 2.2
|
|
Quality of Life (QOL): SF-36 Physical Function Subscale
Survivor: 6mo-12mo
|
-0.76 Score on a scale per 6 months
Interval -1.86 to 0.34
|
-0.56 Score on a scale per 6 months
Interval -1.65 to 0.54
|
-0.81 Score on a scale per 6 months
Interval -2.03 to 0.4
|
|
Quality of Life (QOL): SF-36 Physical Function Subscale
Partner: Baseline-6mo
|
1.81 Score on a scale per 6 months
Interval 0.01 to 3.61
|
1.94 Score on a scale per 6 months
Interval 0.13 to 3.76
|
0.12 Score on a scale per 6 months
Interval -1.83 to 2.07
|
|
Quality of Life (QOL): SF-36 Physical Function Subscale
Partner: 6mo-12mo
|
-0.89 Score on a scale per 6 months
Interval -2.24 to 0.46
|
-0.04 Score on a scale per 6 months
Interval -1.41 to 1.33
|
1.02 Score on a scale per 6 months
Interval -0.47 to 2.52
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Center for Epidemiological Studies-Depression (CES-D) scale to determine the degree of depressive symptoms. Scores range from 0-60, with higher scores indicating more symptoms that occur at higher frequencies.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Depressive Symptoms: CES-D
Survivor: Baseline-6mo
|
-1.50 Score on a scale per 6 months
Interval -2.96 to -0.04
|
-0.72 Score on a scale per 6 months
Interval -2.14 to 0.7
|
-1.10 Score on a scale per 6 months
Interval -2.63 to 0.44
|
|
Depressive Symptoms: CES-D
Survivor: 6mo-12mo
|
-0.10 Score on a scale per 6 months
Interval -1.35 to 1.16
|
0.26 Score on a scale per 6 months
Interval -0.99 to 1.5
|
-0.21 Score on a scale per 6 months
Interval -1.59 to 1.18
|
|
Depressive Symptoms: CES-D
Partner: Baseline-6mo
|
-1.41 Score on a scale per 6 months
Interval -2.65 to -0.16
|
-1.73 Score on a scale per 6 months
Interval -2.95 to -0.52
|
-1.76 Score on a scale per 6 months
Interval -3.11 to -0.41
|
|
Depressive Symptoms: CES-D
Partner: 6mo-12mo
|
1.07 Score on a scale per 6 months
Interval -0.3 to 2.45
|
-0.29 Score on a scale per 6 months
Interval -1.64 to 1.05
|
0.83 Score on a scale per 6 months
Interval -0.68 to 2.34
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are total number of individuals (survivors + partners)
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form 8a, using T score, standardized to mean = 50, SD = 10. Possible range for this short form is 37.1-83.1. Higher T scores reflect higher anxiety. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=164 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Anxiety: PROMIS Anxiety Short Form
Survivor: Baseline-6mo
|
-1.93 T score on a scale per 6 months
Interval -3.36 to -0.51
|
-2.23 T score on a scale per 6 months
Interval -3.62 to -0.84
|
-1.18 T score on a scale per 6 months
Interval -2.69 to 0.33
|
|
Anxiety: PROMIS Anxiety Short Form
Survivor: 6mo-12mo
|
-0.30 T score on a scale per 6 months
Interval -1.8 to 1.21
|
0.42 T score on a scale per 6 months
Interval -1.08 to 1.91
|
-0.23 T score on a scale per 6 months
Interval -1.89 to 1.44
|
|
Anxiety: PROMIS Anxiety Short Form
Partner: Baseline-6mo
|
-1.71 T score on a scale per 6 months
Interval -3.09 to -0.33
|
-0.94 T score on a scale per 6 months
Interval -2.28 to 0.41
|
-1.40 T score on a scale per 6 months
Interval -2.89 to 0.1
|
|
Anxiety: PROMIS Anxiety Short Form
Partner: 6mo-12mo
|
1.17 T score on a scale per 6 months
Interval -0.46 to 2.8
|
-0.16 T score on a scale per 6 months
Interval -1.74 to 1.42
|
-1.25 T score on a scale per 6 months
Interval -3.02 to 0.52
|
SECONDARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.
Measured by the Fear of Recurrence scale to assess the amount of concern survivors have about their cancer returning in the future. Participants respond to 22 questions ranging from 1 (strongly agree) to 5 (strongly disagree). The possible range is 22-110. Higher scores reflect higher fear. Reported values reflect the estimated slope over 6-months.
Outcome measures
| Measure |
Arm I (Supervised Exercise Together)
n=82 Participants
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=85 Participants
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention (supervised): Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=81 Participants
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Fear of Recurrence
Survivor: Baseline-6mo
|
-2.61 Score on a scale per 6 months
Interval -5.01 to -0.2
|
-2.48 Score on a scale per 6 months
Interval -4.82 to -0.14
|
-3.72 Score on a scale per 6 months
Interval -6.31 to -1.13
|
|
Fear of Recurrence
Survivor: 6mo-12mo
|
-1.63 Score on a scale per 6 months
Interval -3.99 to 0.73
|
-1.72 Score on a scale per 6 months
Interval -4.04 to 0.59
|
-0.31 Score on a scale per 6 months
Interval -2.89 to 2.28
|
Adverse Events
Arm I (Supervised Exercise Together)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm II (Supervised Exercise Separately)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm III (Unsupervised Exercise Separately)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Supervised Exercise Together)
n=164 participants at risk
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 participants at risk
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 participants at risk
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention: Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Infections and infestations
Abscess - survivors
|
1.2%
2/164 • Number of events 2 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/170 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/162 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
Surgical and medical procedures
Surgery - survivors
|
0.61%
1/164 • Number of events 1 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.59%
1/170 • Number of events 1 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.62%
1/162 • Number of events 1 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
Vascular disorders
TIA - survivors
|
0.61%
1/164 • Number of events 1 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/170 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/162 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
Surgical and medical procedures
Surgery - partners
|
0.00%
0/164 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.59%
1/170 • Number of events 1 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/162 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
Other adverse events
| Measure |
Arm I (Supervised Exercise Together)
n=164 participants at risk
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm II (Supervised Exercise Separately)
n=170 participants at risk
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Exercise Intervention: Complete supervised exercise
Questionnaire Administration: Ancillary studies
|
Arm III (Unsupervised Exercise Separately)
n=162 participants at risk
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Exercise Intervention: Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint or muscle pain - survivors
|
5.5%
9/164 • Number of events 9 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
3.5%
6/170 • Number of events 6 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
1.9%
3/162 • Number of events 3 • An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
Additional Information
Dr. Kerri Winters-Stone
Oregon Health & Science University
Phone: 503-494-0813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place