Trial Outcomes & Findings for Physical Activity and Participation (NCT NCT02268916)
NCT ID: NCT02268916
Last Updated: 2022-09-19
Results Overview
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
6 months
Results posted on
2022-09-19
Participant Flow
Participant milestones
| Measure |
Intervention
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
35
|
42
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
Reasons for withdrawal
| Measure |
Intervention
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Participant did not have diabetes
|
1
|
0
|
|
Overall Study
Did not complete home monitoring activities after baseline visit
|
9
|
4
|
Baseline Characteristics
Physical Activity and Participation
Baseline characteristics by cohort
| Measure |
Intervention
n=51 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=52 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Continuous
|
72.83 years
STANDARD_DEVIATION 5.55 • n=5 Participants
|
71.54 years
STANDARD_DEVIATION 6.73 • n=7 Participants
|
72.14 years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 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
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only participants who completed the home monitoring activities were included in the outcomes analysis.
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
Outcome measures
| Measure |
Intervention
n=35 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=42 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Physical Activity
|
401.88 KCal/week
Standard Deviation 3909.59
|
-263.81 KCal/week
Standard Deviation 4414.79
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only participants with completed surveys were included in the analysis.
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.
Outcome measures
| Measure |
Intervention
n=35 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=42 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Social Participation
Satisfaction social roles
|
0.18 T-score
Standard Deviation 7.47
|
0.63 T-score
Standard Deviation 8.43
|
|
Social Participation
Satisfaction discretionary social roles
|
0.35 T-score
Standard Deviation 8.14
|
0.85 T-score
Standard Deviation 7.29
|
|
Social Participation
Ability to participate social roles and activities
|
-0.55 T-score
Standard Deviation 7.50
|
-0.36 T-score
Standard Deviation 7.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Only participants who completed the 6-months physical function assessment were included in the analysis.
Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds).
Outcome measures
| Measure |
Intervention
n=32 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=38 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Physical Function
|
0.01 seconds
Standard Deviation 1.68
|
-0.25 seconds
Standard Deviation 2.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Only participants who completed the 6-months physical function assessment were included in the analysis.
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second).
Outcome measures
| Measure |
Intervention
n=32 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=38 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Physical Function
|
0.01 meter per second
Standard Deviation 0.14
|
0.00 meter per second
Standard Deviation 0.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Only participants who completed the 6-months physical function assessment were included in the analysis.
Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters).
Outcome measures
| Measure |
Intervention
n=32 Participants
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed
n=36 Participants
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling
|
|---|---|---|
|
Physical Function
|
4.23 meters
Standard Deviation 45.97
|
5.19 meters
Standard Deviation 35.73
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Wait-listed Without OT-Led Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-listed With OT-Led Counseling
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=52 participants at risk
OT-led counseling based on home activity pattern
Counseling: OT led counseling
|
Wait-listed Without OT-Led Counseling
n=52 participants at risk
Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education
|
Wait-listed With OT-Led Counseling
n=52 participants at risk
Usual activity during the study. At the end of the study, will receive OT-led counseling
Counseling: At the end of the study, will receive OT-led counseling
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Minor , possibly study related adverse events
|
3.8%
2/52 • Number of events 2 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
|
Musculoskeletal and connective tissue disorders
Minor, possibly study related adverse events
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
1.9%
1/52 • Number of events 1 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
|
Musculoskeletal and connective tissue disorders
Minor, possibly related to the study
|
1.9%
1/52 • Number of events 1 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
0.00%
0/52 • For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place