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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

Baseline, 13 weeks, 26 weeks, 39 weeks

Results posted on

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

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 9

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Delay Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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.

Additional Information

Dr. Linda Li

University of British Columbia

Phone: 604-207-4020

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place