Trial Outcomes & Findings for Optimizing Physical Activity Outcomes After Total Knee Arthroplasty (NCT NCT03226106)
NCT ID: NCT03226106
Last Updated: 2024-10-16
Results Overview
Accelerometer-based measurement of free-living daily step count
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
End of intervention (14 weeks)
Results posted on
2024-10-16
Participant Flow
114 participants were enrolled in the study. There were n=22 participants lost to follow-up before randomization: n=14 post-consent screen fail, n=7 withdrew, and n=1 no valid baseline activity data. n=92 participants were randomized in the study.
Participant milestones
| Measure |
Physical Activity Behavior Intervention
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
Week 8
|
43
|
46
|
|
Overall Study
Week 14 (Intervention End)
|
43
|
46
|
|
Overall Study
COMPLETED
|
41
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Physical Activity Behavior Intervention
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Optimizing Physical Activity Outcomes After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Physical Activity Behavior Intervention
n=46 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
< High School / High School
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Education
Bachelor or Associate Degree
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Education
Master's or Professional Degree
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of intervention (14 weeks)Accelerometer-based measurement of free-living daily step count
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Free-living Daily Step Count
|
6947 step count
Interval 4656.0 to 8825.0
|
6339 step count
Interval 4851.0 to 8145.0
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
30-Second Chair-Stand Test W14
|
13 sit-stand-sit transitions
Interval 10.0 to 14.0
|
12 sit-stand-sit transitions
Interval 9.0 to 15.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
30-Second Chair-Stand Test W38
|
14 sit-stand-sit transitions
Interval 12.0 to 16.0
|
14 sit-stand-sit transitions
Interval 11.0 to 16.0
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)Physical function test measuring the total distance walked in a span of six minutes.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Six-Minute Walk Test W14
|
433 meters
Interval 391.0 to 478.0
|
434 meters
Interval 365.0 to 515.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)Physical function test measuring the total distance walked in a span of six minutes.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Six-Minute Walk Test W38
|
452 meters
Interval 427.0 to 488.0
|
451 meters
Interval 379.0 to 489.0
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Timed Up-and-Go Test W14
|
9.8 seconds
Interval 8.2 to 9.7
|
9.4 seconds
Interval 7.8 to 10.9
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Timed Up-and-Go Test W38
|
9.1 seconds
Interval 7.4 to 9.7
|
9.0 seconds
Interval 7.5 to 10.3
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index W14
|
18 score on a scale
Interval 5.0 to 26.0
|
21 score on a scale
Interval 12.0 to 30.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of the study)Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index W38
|
13 score on a scale
Interval 2.0 to 22.0
|
22 score on a scale
Interval 6.0 to 34.0
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Veterans RAND 12-Item Health Survey Physical Component W14
|
43 Percentage of total
Interval 38.0 to 50.0
|
39 Percentage of total
Interval 34.0 to 45.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Veterans RAND 12-Item Health Survey Physical Component W38
|
43 Percentage of total
Interval 39.0 to 52.0
|
41 Percentage of total
Interval 35.0 to 49.0
|
SECONDARY outcome
Timeframe: End of intervention (14 weeks)A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=43 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Veterans RAND 12-Item Health Survey Mental Component W14
|
54 Percentage of total
Interval 48.0 to 60.0
|
52 Percentage of total
Interval 44.0 to 60.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Veterans RAND 12-Item Health Survey Mental Component W38
|
55 Percentage of total
Interval 52.0 to 59.0
|
51 Percentage of total
Interval 42.0 to 60.0
|
SECONDARY outcome
Timeframe: 24 weeks after intervention (week 38 of study)Accelerometer-based measurement of free-living daily step count
Outcome measures
| Measure |
Physical Activity Behavior Intervention
n=41 Participants
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 Participants
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Free-living Daily Step Count W38
|
7287 step count
Interval 4279.0 to 9630.0
|
6855 step count
Interval 4441.0 to 9118.0
|
Adverse Events
Physical Activity Behavior Intervention
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Attention Control
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Physical Activity Behavior Intervention
n=46 participants at risk
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 participants at risk
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
General disorders
General disorders and administration site conditions
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & connective tissue disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Nervous system disorders
Nervous System Disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Vascular disorders
Vascular disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
Other adverse events
| Measure |
Physical Activity Behavior Intervention
n=46 participants at risk
A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: 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 researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
|
Attention Control
n=46 participants at risk
Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
23.9%
11/46 • Number of events 22 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
32.6%
15/46 • Number of events 28 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Cardiac disorders
Cardiac disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Eye disorders
Eye disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
General disorders
General disorders and administration site conditions
|
8.7%
4/46 • Number of events 4 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
10.9%
5/46 • Number of events 7 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Immune system disorders
Immune system disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Infections and infestations
Infections and infestations
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
8.7%
4/46 • Number of events 4 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & connective tissue disorders
|
10.9%
5/46 • Number of events 6 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
17.4%
8/46 • Number of events 11 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Psychiatric disorders
Psychiatric disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
0.00%
0/46 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
4.3%
2/46 • Number of events 3 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
|
Vascular disorders
Vascular disorder
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
Additional Information
Cory Christiansen, PT, PhD
Eastern Colorado VA Medical Center
Phone: 303-724-9101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place