Trial Outcomes & Findings for Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (NCT NCT02738086)
NCT ID: NCT02738086
Last Updated: 2020-02-18
Results Overview
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
3 months
Results posted on
2020-02-18
Participant Flow
Participant milestones
| Measure |
Early PABC Intervention (Months 1-3)
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Wait-List Control Intervention (Months 4-6)
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
Baseline characteristics by cohort
| Measure |
Early PABC Intervention
n=16 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Wait-List Control Intervention
n=15 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
BMI
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6 • n=7 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Time Since Amputation (months)
|
37 months
STANDARD_DEVIATION 41 • n=5 Participants
|
36 months
STANDARD_DEVIATION 16 • n=7 Participants
|
36 months
STANDARD_DEVIATION 31 • n=5 Participants
|
|
Level of Amputation
Transtibial
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Level of Amputation
Transfemoral
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Geriatric Depression Scale score
|
4.1 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Mini-Mental Status Examination score
|
28.4 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Chakrabarty Grade score
|
84.8 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
85.7 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
|
85.2 units on a scale
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Functional Comorbidity Index score
|
6.8 Number of Comorbidities
STANDARD_DEVIATION 3.3 • n=5 Participants
|
6.0 Number of Comorbidities
STANDARD_DEVIATION 3.2 • n=7 Participants
|
6.4 Number of Comorbidities
STANDARD_DEVIATION 3.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsRetention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Outcome measures
| Measure |
Early PABC Intervention
n=16 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=15 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Retention Rate
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
Outcome measures
| Measure |
Early PABC Intervention
n=29 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Dose Goal Attainment
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 monthsAcceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
Outcome measures
| Measure |
Early PABC Intervention
n=29 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Acceptability
|
5.8 score on a scale
Standard Deviation 0.8
|
—
|
PRIMARY outcome
Timeframe: 3 monthsSafety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
Outcome measures
| Measure |
Early PABC Intervention
n=16 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=15 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Study-Related Adverse Events
|
20 Adverse Events
|
29 Adverse Events
|
SECONDARY outcome
Timeframe: 3 monthsPhysical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Outcome measures
| Measure |
Early PABC Intervention
n=14 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=13 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Accelerometer-Based Physical Activity
|
1609 Steps
Interval 826.0 to 2393.0
|
1897 Steps
Interval 1242.0 to 2551.0
|
SECONDARY outcome
Timeframe: 3 monthsThe Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Outcome measures
| Measure |
Early PABC Intervention
n=15 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=15 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Late Life Function and Disability Scale, Frequency
|
49.3 score on a scale
Interval 46.2 to 52.4
|
54.5 score on a scale
Interval 48.5 to 60.6
|
SECONDARY outcome
Timeframe: 6 monthsPhysical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Outcome measures
| Measure |
Early PABC Intervention
n=14 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=13 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Accelerometer-Based Physical Activity
|
1716 Steps
Interval 948.0 to 2483.0
|
1773 Steps
Interval 1189.0 to 2357.0
|
SECONDARY outcome
Timeframe: 6 monthsThe Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Outcome measures
| Measure |
Early PABC Intervention
n=14 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=13 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Late Life Function and Disability Scale, Frequency
|
52.5 score on a scale
Interval 48.6 to 56.3
|
51.3 score on a scale
Interval 48.4 to 54.3
|
SECONDARY outcome
Timeframe: 3 monthsThe Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Outcome measures
| Measure |
Early PABC Intervention
n=15 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=15 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Late Life Function and Disability Scale, Limitation
|
71.4 score on a scale
Interval 63.2 to 79.7
|
68.1 score on a scale
Interval 55.3 to 80.9
|
SECONDARY outcome
Timeframe: 6 monthsThe Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Outcome measures
| Measure |
Early PABC Intervention
n=14 Participants
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 2: Wait-List Control Intervention
n=13 Participants
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|
|
Late Life Function and Disability Scale, Limitation
|
74.3 score on a scale
Interval 65.3 to 83.3
|
68.6 score on a scale
Interval 60.7 to 76.4
|
Adverse Events
GROUP 1: Early PABC Intervention (Months 1-3)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GROUP 1: No Contact Phase (Months 4-6)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
GROUP 2: PABC Attention Control (Months 1-3)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GROUP 2: PABC Intervention (Months 4-6)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GROUP 1: Early PABC Intervention (Months 1-3)
n=16 participants at risk
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 1: No Contact Phase (Months 4-6)
n=16 participants at risk
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
|
GROUP 2: PABC Attention Control (Months 1-3)
n=15 participants at risk
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
|
GROUP 2: PABC Intervention (Months 4-6)
n=15 participants at risk
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Disorder - Other
|
6.2%
1/16 • Number of events 1 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
6.2%
1/16 • Number of events 1 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/15 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/15 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
|
Skin and subcutaneous tissue disorders
Non-Healing Wounds
|
0.00%
0/16 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/16 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
6.7%
1/15 • Number of events 1 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/15 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/16 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
6.2%
1/16 • Number of events 1 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/15 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
0.00%
0/15 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
Other adverse events
| Measure |
GROUP 1: Early PABC Intervention (Months 1-3)
n=16 participants at risk
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
GROUP 1: No Contact Phase (Months 4-6)
n=16 participants at risk
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
|
GROUP 2: PABC Attention Control (Months 1-3)
n=15 participants at risk
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
|
GROUP 2: PABC Intervention (Months 4-6)
n=15 participants at risk
GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
4/16 • Number of events 4 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
12.5%
2/16 • Number of events 2 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
33.3%
5/15 • Number of events 5 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
20.0%
3/15 • Number of events 3 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
|
Skin and subcutaneous tissue disorders
Wound
|
43.8%
7/16 • Number of events 8 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
18.8%
3/16 • Number of events 3 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
33.3%
5/15 • Number of events 5 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
40.0%
6/15 • Number of events 6 • For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place