Trial Outcomes & Findings for SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis (NCT NCT02585323)
NCT ID: NCT02585323
Last Updated: 2025-10-06
Results Overview
Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.
COMPLETED
NA
51 participants
Baseline, 13 weeks, 26 weeks, 39 weeks
2025-10-06
Participant Flow
Patient participants were recruited between 2017 and 2019 from the Mary Pack Arthritis Program (Vancouver Coastal Health Authority) and the Fraser Health Authority in British Columbia, Canada. We also posted study information on Facebook, Twitter, Kajiji, and Craigslist.
Participant milestones
| Measure |
Immediate Intervention Group
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Intervention Group
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Baseline
STARTED
|
26
|
25
|
|
Baseline
COMPLETED
|
26
|
25
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Week 13 (RCT Period)
STARTED
|
26
|
25
|
|
Week 13 (RCT Period)
COMPLETED
|
24
|
24
|
|
Week 13 (RCT Period)
NOT COMPLETED
|
2
|
1
|
|
Week 26 (All Received Intervention)
STARTED
|
24
|
24
|
|
Week 26 (All Received Intervention)
COMPLETED
|
22
|
24
|
|
Week 26 (All Received Intervention)
NOT COMPLETED
|
2
|
0
|
|
Week 39 (All Received Intervention)
STARTED
|
22
|
24
|
|
Week 39 (All Received Intervention)
COMPLETED
|
20
|
24
|
|
Week 39 (All Received Intervention)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Immediate Intervention Group
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Intervention Group
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Week 13 (RCT Period)
Withdrawal by Subject
|
2
|
0
|
|
Week 13 (RCT Period)
Participant refused assessment
|
0
|
1
|
|
Week 26 (All Received Intervention)
Withdrawal by Subject
|
2
|
0
|
|
Week 39 (All Received Intervention)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delay Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 8 • n=26 Participants
|
64.8 years
STANDARD_DEVIATION 9 • n=25 Participants
|
64.9 years
STANDARD_DEVIATION 8.5 • n=51 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=26 Participants
|
19 Participants
n=25 Participants
|
42 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=26 Participants
|
6 Participants
n=25 Participants
|
9 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
26 participants
n=26 Participants
|
25 participants
n=25 Participants
|
51 participants
n=51 Participants
|
|
Daily number of minutes in moderate/vigorous physical activity
|
31.0 Minutes per day
STANDARD_DEVIATION 37.3 • n=26 Participants
|
71.3 Minutes per day
STANDARD_DEVIATION 99.8 • n=25 Participants
|
50.8 Minutes per day
STANDARD_DEVIATION 76.7 • n=51 Participants
|
|
Daily number of sedentary minutes
|
567.5 Minutes per day
STANDARD_DEVIATION 183.1 • n=26 Participants
|
551.1 Minutes per day
STANDARD_DEVIATION 234.9 • n=25 Participants
|
559.4 Minutes per day
STANDARD_DEVIATION 208.1 • n=51 Participants
|
|
Daily number of steps
|
6294.0 Steps per day
STANDARD_DEVIATION 3418.0 • n=26 Participants
|
7030.1 Steps per day
STANDARD_DEVIATION 3921.6 • n=25 Participants
|
6654.8 Steps per day
STANDARD_DEVIATION 3655.3 • n=51 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score - Symptom
|
68.5 units on a scale
STANDARD_DEVIATION 10.7 • n=26 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 12.3 • n=25 Participants
|
67.2 units on a scale
STANDARD_DEVIATION 11.5 • n=51 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score - Pain
|
72.6 units on a scale
STANDARD_DEVIATION 13.5 • n=26 Participants
|
65.1 units on a scale
STANDARD_DEVIATION 13.7 • n=25 Participants
|
69.0 units on a scale
STANDARD_DEVIATION 14.0 • n=51 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score - Activity of Daily Living
|
75.5 units on a scale
STANDARD_DEVIATION 14.7 • n=26 Participants
|
72.2 units on a scale
STANDARD_DEVIATION 15.8 • n=25 Participants
|
73.9 units on a scale
STANDARD_DEVIATION 15.2 • n=51 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score - Sports and Recreation
|
47.9 units on a scale
STANDARD_DEVIATION 23.7 • n=26 Participants
|
46.8 units on a scale
STANDARD_DEVIATION 25.4 • n=25 Participants
|
47.4 units on a scale
STANDARD_DEVIATION 24.3 • n=51 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score - Quality of Life
|
44.0 units on a scale
STANDARD_DEVIATION 16.0 • n=26 Participants
|
47.5 units on a scale
STANDARD_DEVIATION 16.0 • n=25 Participants
|
45.7 units on a scale
STANDARD_DEVIATION 17.4 • n=51 Participants
|
|
Partners in Health Scale
|
76.8 units on a scale
STANDARD_DEVIATION 11.0 • n=26 Participants
|
78.0 units on a scale
STANDARD_DEVIATION 12.0 • n=25 Participants
|
77.4 units on a scale
STANDARD_DEVIATION 11.4 • n=51 Participants
|
|
Patient Health Questionnaire-9
|
5.2 units on a scale
STANDARD_DEVIATION 4.6 • n=26 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 5.3 • n=25 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 4.9 • n=51 Participants
|
|
Self-Reported Habit Index - Sitting at Work subscale
|
5.0 units on a scale
STANDARD_DEVIATION 1.4 • n=26 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.1 • n=25 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 1.8 • n=51 Participants
|
|
Self-Reported Habit Index - Sitting at Leisure subscale
|
4.8 units on a scale
STANDARD_DEVIATION 1.1 • n=26 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 1.4 • n=25 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.2 • n=51 Participants
|
|
Self-Reported Habit Index - Walking subscale
|
4.3 units on a scale
STANDARD_DEVIATION 1.8 • n=26 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.0 • n=25 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 1.9 • n=51 Participants
|
|
Theory of Planned Behavior Questionnaire - Attitude toward Physical Activity
|
6.0 units on a scale
STANDARD_DEVIATION 0.6 • n=26 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 0.6 • n=25 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 0.6 • n=51 Participants
|
|
Theory of Planned Behavior Questionnaire - Subjective Norm
|
6.2 units on a scale
STANDARD_DEVIATION 0.6 • n=26 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 0.8 • n=25 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 0.7 • n=51 Participants
|
|
Theory of Planned Behavior Questionnaire - Perceived Control
|
5.8 units on a scale
STANDARD_DEVIATION 1.0 • n=26 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 0.7 • n=25 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 0.9 • n=51 Participants
|
|
Theory of Planned Behavior Questionnaire - Intention
|
6.2 units on a scale
STANDARD_DEVIATION 0.8 • n=26 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 0.8 • n=25 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 0.8 • n=51 Participants
|
PRIMARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 1 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown 29 weeks: I Group: 2 withdrew - reason unknown
Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Daily Number of Minutes in Moderate/Vigorous Physical Activity
Baseline (T0)
|
31.0 Minutes per day
Standard Deviation 37.3
|
71.3 Minutes per day
Standard Deviation 99.8
|
|
Daily Number of Minutes in Moderate/Vigorous Physical Activity
13 weeks (T1)
|
37.7 Minutes per day
Standard Deviation 30.5
|
49.4 Minutes per day
Standard Deviation 63.6
|
|
Daily Number of Minutes in Moderate/Vigorous Physical Activity
26 weeks (T2)
|
37.0 Minutes per day
Standard Deviation 32.3
|
74.6 Minutes per day
Standard Deviation 102.1
|
|
Daily Number of Minutes in Moderate/Vigorous Physical Activity
39 weeks (T3)
|
34.0 Minutes per day
Standard Deviation 25.2
|
54.8 Minutes per day
Standard Deviation 66.2
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 1 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown 29 weeks: I Group: 2 withdrew - reason unknown
Time spent in sedentary behaviour was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of \<=1.5 METs, occurring in bouts of \>= 20 minutes during waking hours.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Daily Number of Sedentary Minutes
Baseline (T0)
|
567.5 Minutes per day
Standard Deviation 183.1
|
551.1 Minutes per day
Standard Deviation 234.9
|
|
Daily Number of Sedentary Minutes
13 weeks (T1)
|
531.4 Minutes per day
Standard Deviation 173.5
|
558.3 Minutes per day
Standard Deviation 224.9
|
|
Daily Number of Sedentary Minutes
26 weeks (T2)
|
492.5 Minutes per day
Standard Deviation 156.6
|
499.5 Minutes per day
Standard Deviation 248.9
|
|
Daily Number of Sedentary Minutes
39 weeks (T3)
|
502.8 Minutes per day
Standard Deviation 135.3
|
483.1 Minutes per day
Standard Deviation 225.4
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Symptom Subscale ranges from 0 - 100, with 0 indicates extreme knee symptoms and 100 indicates no knee symptoms.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom
Baseline (T0)
|
68.5 units on a scale
Standard Deviation 10.7
|
65.7 units on a scale
Standard Deviation 12.3
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom
13 weeks (T1)
|
69.3 units on a scale
Standard Deviation 12.7
|
66.9 units on a scale
Standard Deviation 14.9
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom
26 weeks (T2)
|
65.4 units on a scale
Standard Deviation 45.8
|
72.2 units on a scale
Standard Deviation 16.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom
39 weeks (T3)
|
68.4 units on a scale
Standard Deviation 16.3
|
72.5 units on a scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Pain Subscale ranges from 0 - 100, with 0 indicates extreme knee pain and 100 indicates no knee pain.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
Baseline (T0)
|
72.6 score on a scale
Standard Deviation 13.5
|
65.1 score on a scale
Standard Deviation 13.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
13 weeks (T1)
|
73.1 score on a scale
Standard Deviation 15.3
|
65.9 score on a scale
Standard Deviation 15.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
26 weeks (T2)
|
72.5 score on a scale
Standard Deviation 18.3
|
74.8 score on a scale
Standard Deviation 15.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
39 weeks (T3)
|
72.1 score on a scale
Standard Deviation 19.8
|
72.8 score on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Sport and Recreation Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with sport and recreational activities due to knee problems and 100 indicates no difficulties.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation
Baseline (T0)
|
47.9 units on a scale
Standard Deviation 23.7
|
46.8 units on a scale
Standard Deviation 25.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation
13 weeks (T1)
|
47.1 units on a scale
Standard Deviation 22.4
|
52.5 units on a scale
Standard Deviation 22.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation
26 weeks (T2)
|
50.5 units on a scale
Standard Deviation 30.1
|
62.5 units on a scale
Standard Deviation 22.5
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation
39 weeks (T3)
|
51.6 units on a scale
Standard Deviation 30.4
|
55.8 units on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Activity of Daily Living Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with activity of daily living and 100 indicates no difficulties.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living
39 weeks (T3)
|
74.8 score on a scale
Standard Deviation 20.7
|
80.0 score on a scale
Standard Deviation 14.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living
Baseline (T0)
|
75.5 score on a scale
Standard Deviation 14.7
|
72.2 score on a scale
Standard Deviation 15.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living
13 weeks (T1)
|
75.0 score on a scale
Standard Deviation 13.1
|
70.3 score on a scale
Standard Deviation 16.9
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living
26 weeks (T2)
|
77.7 score on a scale
Standard Deviation 18.9
|
80.3 score on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Quality of Life Subscale ranges from 0 - 100, with 0 indicates extreme problems with the knee and 100 indicates no problems.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
Baseline (T0)
|
44.0 score on a scale
Standard Deviation 16.0
|
47.5 score on a scale
Standard Deviation 16.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
13 weeks (T1)
|
48.7 score on a scale
Standard Deviation 17.5
|
46.9 score on a scale
Standard Deviation 13.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
26 weeks (T2)
|
49.4 score on a scale
Standard Deviation 15.7
|
54.7 score on a scale
Standard Deviation 14.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
39 weeks (T3)
|
49.3 score on a scale
Standard Deviation 19.1
|
54.4 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. Range 0-27; lower score = less depressive symptoms),
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
The Patient Health Questionnaire-9 (PHQ-9)
26 weeks (T2)
|
3.6 score on a scale
Standard Deviation 3.3
|
4.5 score on a scale
Standard Deviation 5.2
|
|
The Patient Health Questionnaire-9 (PHQ-9)
39 weeks (T3)
|
4.2 score on a scale
Standard Deviation 4.1
|
4.5 score on a scale
Standard Deviation 5.3
|
|
The Patient Health Questionnaire-9 (PHQ-9)
Baseline (T0)
|
5.2 score on a scale
Standard Deviation 4.6
|
5.4 score on a scale
Standard Deviation 5.3
|
|
The Patient Health Questionnaire-9 (PHQ-9)
13 weeks (T1)
|
4.0 score on a scale
Standard Deviation 3.0
|
4.7 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, and 9Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Partners in Health Scale ranges from 0 to 96, calculated from responses to 12 items on a 9-point Likert scale. A score of 0 represents poor self-management, and a score of 96 represents greater self-management capabilities.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Partners in Health Scale
Baseline (T0)
|
76.8 score on a scale
Standard Deviation 11.0
|
78.0 score on a scale
Standard Deviation 12.0
|
|
Partners in Health Scale
13 weeks (T1)
|
76.7 score on a scale
Standard Deviation 11.5
|
81.6 score on a scale
Standard Deviation 9.6
|
|
Partners in Health Scale
26 weeks (T2)
|
78.9 score on a scale
Standard Deviation 9.0
|
82.6 score on a scale
Standard Deviation 9.3
|
|
Partners in Health Scale
29 weeks (T3)
|
81.0 score on a scale
Standard Deviation 7.0
|
82.6 score on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Self-Reported Habit Index (SRHI) - Sitting at Work Subscale
Baseline (T0)
|
5.0 score on a scale
Standard Deviation 1.4
|
4.5 score on a scale
Standard Deviation 2.1
|
|
Self-Reported Habit Index (SRHI) - Sitting at Work Subscale
13 weeks (T1)
|
5.2 score on a scale
Standard Deviation 1.6
|
4.4 score on a scale
Standard Deviation 2.0
|
|
Self-Reported Habit Index (SRHI) - Sitting at Work Subscale
26 weeks (T2)
|
4.7 score on a scale
Standard Deviation 2.1
|
4.3 score on a scale
Standard Deviation 2.1
|
|
Self-Reported Habit Index (SRHI) - Sitting at Work Subscale
39 weeks (T3)
|
5.0 score on a scale
Standard Deviation 1.9
|
4.1 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale
39 weeks (T3)
|
5.5 score on a scale
Standard Deviation 1.1
|
4.7 score on a scale
Standard Deviation 1.7
|
|
Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale
Baseline (T0)
|
4.8 score on a scale
Standard Deviation 1.1
|
5.1 score on a scale
Standard Deviation 1.4
|
|
Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale
13 weeks (T1)
|
5.1 score on a scale
Standard Deviation 1.1
|
4.7 score on a scale
Standard Deviation 1.6
|
|
Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale
26 weeks (T2)
|
5.0 score on a scale
Standard Deviation 1.1
|
4.4 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Self-Reported Habit Index (SRHI) - Walking Subscale
Baseline (T0)
|
4.3 score on a scale
Standard Deviation 1.8
|
4.8 score on a scale
Standard Deviation 2.0
|
|
Self-Reported Habit Index (SRHI) - Walking Subscale
13 weeks (T1)
|
4.4 score on a scale
Standard Deviation 1.6
|
4.6 score on a scale
Standard Deviation 2.0
|
|
Self-Reported Habit Index (SRHI) - Walking Subscale
26 weeks (T2)
|
4.6 score on a scale
Standard Deviation 1.8
|
4.8 score on a scale
Standard Deviation 1.6
|
|
Self-Reported Habit Index (SRHI) - Walking Subscale
39 weeks (T3)
|
4.7 score on a scale
Standard Deviation 1.8
|
4.6 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity
Baseline (T0)
|
6.0 score on a scale
Standard Deviation 0.6
|
6.1 score on a scale
Standard Deviation 0.6
|
|
Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity
13 weeks (T1)
|
5.9 score on a scale
Standard Deviation 0.7
|
6.1 score on a scale
Standard Deviation 0.7
|
|
Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity
26 weeks (T2)
|
6.0 score on a scale
Standard Deviation 0.5
|
6.2 score on a scale
Standard Deviation 0.6
|
|
Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity
39 weeks (T3)
|
6.0 score on a scale
Standard Deviation 0.5
|
6.1 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Theory of Planned Behavior Questionnaire - Subjective Norm
Baseline (T0)
|
6.2 score on a scale
Standard Deviation 0.6
|
6.3 score on a scale
Standard Deviation 0.8
|
|
Theory of Planned Behavior Questionnaire - Subjective Norm
13 weeks (T1)
|
6.2 score on a scale
Standard Deviation 0.8
|
6.2 score on a scale
Standard Deviation 0.7
|
|
Theory of Planned Behavior Questionnaire - Subjective Norm
26 weeks (T2)
|
6.1 score on a scale
Standard Deviation 0.8
|
6.3 score on a scale
Standard Deviation 0.8
|
|
Theory of Planned Behavior Questionnaire - Subjective Norm
39 weeks (T3)
|
6.2 score on a scale
Standard Deviation 1.1
|
6.3 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Theory of Planned Behavior Questionnaire - Perceived Control
Baseline (T0)
|
5.8 score on a scale
Standard Deviation 1.0
|
6.1 score on a scale
Standard Deviation 0.7
|
|
Theory of Planned Behavior Questionnaire - Perceived Control
13 weeks (T1)
|
5.6 score on a scale
Standard Deviation 1.4
|
5.8 score on a scale
Standard Deviation 1.2
|
|
Theory of Planned Behavior Questionnaire - Perceived Control
26 weeks (T2)
|
5.6 score on a scale
Standard Deviation 1.5
|
6.2 score on a scale
Standard Deviation 1.0
|
|
Theory of Planned Behavior Questionnaire - Perceived Control
39 weeks (T3)
|
5.7 score on a scale
Standard Deviation 1.4
|
6.2 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, 13 weeks, 26 weeks, 39 weeksPopulation: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Outcome measures
| Measure |
Immediate Group
n=26 Participants
Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz.
|
Delayed Group
n=25 Participants
Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Theory of Planned Behavior Questionnaire - Intention
Baseline (T0)
|
6.2 score on a scale
Standard Deviation 0.8
|
6.3 score on a scale
Standard Deviation 0.8
|
|
Theory of Planned Behavior Questionnaire - Intention
13 weeks (T1)
|
5.9 score on a scale
Standard Deviation 1.0
|
6.4 score on a scale
Standard Deviation 0.6
|
|
Theory of Planned Behavior Questionnaire - Intention
26 weeks (T2)
|
5.7 score on a scale
Standard Deviation 1.1
|
6.3 score on a scale
Standard Deviation 0.6
|
|
Theory of Planned Behavior Questionnaire - Intention
39 weeks (T3)
|
5.8 score on a scale
Standard Deviation 0.8
|
6.3 score on a scale
Standard Deviation 0.9
|
Adverse Events
Immediate Group
Delay Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Group
n=26 participants at risk
Education session, Fitbit/FitViz, PT counselling: Participants received this intervention in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, and an orientation to the Fitbit Flex and the FitViz app. In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities. In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit/FitViz.
|
Delay Group
n=25 participants at risk
Same intervention with a 13-week delay: The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physiotherapist.
In Week 26-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit/FitViz.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall during physical activity
|
7.7%
2/26 • Number of events 2 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
|
4.0%
1/25 • Number of events 1 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
19.2%
5/26 • Number of events 5 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
|
8.0%
2/25 • Number of events 2 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.00%
0/26 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
|
0.00%
0/25 • 39 weeks
Self-reported adverse events were collected, including cardiovascular events, musculoskeletal events (e.g., muscle pain, ligament sprain), or falls while being physically active, were collected.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place