Trial Outcomes & Findings for Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA (NCT NCT02313506)
NCT ID: NCT02313506
Last Updated: 2019-11-19
Results Overview
Participants wore a SenseWear Mini device for 7 days at baseline, and Months 1 and 2. We calculated the average time spent in MVPA accumulated in bouts per day. A bout is defined as 10 consecutive minutes or more at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline; 1 month and 2 months from baseline
Results posted on
2019-11-19
Participant Flow
Our recruitment strategy identified 46 eligible individuals. Recruitment was from January 2015 to March 2015. Participants were recruited from 1) postings on Facebook, Twitter, Kajiji, Craigslist, and the Arthritis Research Canada website, 2) emails sent by the Arthritis Consumer Experts the Vancouver Coastal Health Research Institute to its staff.
Participant milestones
| Measure |
Immediate Intervention Group
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
Same intervention with a 1 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA
Baseline characteristics by cohort
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
Same intervention with a 1 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Marital Status
Married/Common Law
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Marital Status
Separated/ Divorced
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Widowed/ Never Married/ Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Gross annual household income
Under $12,000
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gross annual household income
$12,001 - $24,000
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gross annual household income
$24,001 - $40,000
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gross annual household income
$40,001 - $60,000
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gross annual household income
$60,001 - $80,000
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gross annual household income
$80,001 - $100,000
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gross annual household income
Over $100,000
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Gross annual household income
No answer
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Diagnosed with OA
Yes
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Diagnosed with OA
No, but met the 'likely OA' criteria
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
In general, would you say your health is ...
Excellent
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
In general, would you say your health is ...
Very good
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
In general, would you say your health is ...
Good
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
In general, would you say your health is ...
Fair
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
In general, would you say your health is ...
Poor
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Compared to one year ago, how would you rate your health in general?
Much better
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Compared to one year ago, how would you rate your health in general?
Somewhat better
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Compared to one year ago, how would you rate your health in general?
About the same
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Compared to one year ago, how would you rate your health in general?
Somewhat worse
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Compared to one year ago, how would you rate your health in general?
Much worse
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Comorbid conditions
|
3 comorbid conditions
n=5 Participants
|
2 comorbid conditions
n=7 Participants
|
2.5 comorbid conditions
n=5 Participants
|
|
Body Mass Index
|
29.1 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Participants wore a SenseWear Mini device for 7 days at baseline, and Months 1 and 2. We calculated the average time spent in MVPA accumulated in bouts per day. A bout is defined as 10 consecutive minutes or more at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Baseline
|
41.3 Minutes per day
Standard Deviation 51.6
|
66.5 Minutes per day
Standard Deviation 71.0
|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
1 Month
|
64.2 Minutes per day
Standard Deviation 70.5
|
56.0 Minutes per day
Standard Deviation 60.1
|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
2 Months
|
67.7 Minutes per day
Standard Deviation 85.8
|
81.9 Minutes per day
Standard Deviation 64.4
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of \> 20 minutes during waking hours.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
Time Spent in Sedentary Behavior
Baseline
|
548.4 Minutes per day
Standard Deviation 169.1
|
453.3 Minutes per day
Standard Deviation 180.5
|
|
Time Spent in Sedentary Behavior
1 Month
|
524.9 Minutes per day
Standard Deviation 192.1
|
492.8 Minutes per day
Standard Deviation 164.8
|
|
Time Spent in Sedentary Behavior
2 Months
|
523.9 Minutes per day
Standard Deviation 200.2
|
393.1 Minutes per day
Standard Deviation 144.2
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
KOOS - Symptoms
2 Months
|
72.5 score on a scale
Standard Deviation 20.2
|
73.2 score on a scale
Standard Deviation 15.4
|
|
KOOS - Symptoms
Baseline
|
70.6 score on a scale
Standard Deviation 15.8
|
70.4 score on a scale
Standard Deviation 14.9
|
|
KOOS - Symptoms
1 Month
|
68.3 score on a scale
Standard Deviation 18.4
|
66.8 score on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
KOOS - Pain
Baseline
|
74.5 score on a scale
Standard Deviation 16.2
|
68.6 score on a scale
Standard Deviation 16.1
|
|
KOOS - Pain
1 Month
|
71.4 score on a scale
Standard Deviation 17.5
|
71.6 score on a scale
Standard Deviation 15.2
|
|
KOOS - Pain
2 Months
|
79.1 score on a scale
Standard Deviation 13
|
74 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Activities of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
KOOS - Activities of Daily Living
1 Month
|
75.1 score on a scale
Standard Deviation 19.7
|
79.1 score on a scale
Standard Deviation 18.9
|
|
KOOS - Activities of Daily Living
2 Months
|
83 score on a scale
Standard Deviation 14.9
|
82.2 score on a scale
Standard Deviation 17.1
|
|
KOOS - Activities of Daily Living
Baseline
|
81.8 score on a scale
Standard Deviation 17.1
|
78.3 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Sport and Recreation Function was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
KOOS - Sport and Recreation Function
1 Month
|
54.7 score on a scale
Standard Deviation 28.3
|
54.4 score on a scale
Standard Deviation 31.4
|
|
KOOS - Sport and Recreation Function
2 Months
|
64.4 score on a scale
Standard Deviation 28.4
|
55.6 score on a scale
Standard Deviation 22.6
|
|
KOOS - Sport and Recreation Function
Baseline
|
55.6 score on a scale
Standard Deviation 29.5
|
51.2 score on a scale
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Quality of life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
KOOS - Knee-related Quality of Life
Baseline
|
53.3 score on a scale
Standard Deviation 18.4
|
47.4 score on a scale
Standard Deviation 16.1
|
|
KOOS - Knee-related Quality of Life
1 Month
|
51.8 score on a scale
Standard Deviation 19.5
|
48.9 score on a scale
Standard Deviation 19.3
|
|
KOOS - Knee-related Quality of Life
2 Months
|
56.6 score on a scale
Standard Deviation 20.2
|
52.3 score on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline; 1 month and 2 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
The Partners in Health Scale is a 12-item measure designed to assess disease self-management abilities including knowledge of health conditions, ability to participate in decision-making with health care professionals, and ability to pursue a healthy lifestyle. Scores range from 0 to 96, with lower being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
|
Delayed Intervention Group
n=17 Participants
Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
|
|---|---|---|
|
Partners in Health Scale
Baseline
|
21.9 score on a scale
Standard Deviation 17.6
|
26.8 score on a scale
Standard Deviation 15.3
|
|
Partners in Health Scale
1 Month
|
17.2 score on a scale
Standard Deviation 17
|
31.9 score on a scale
Standard Deviation 17.9
|
|
Partners in Health Scale
2 Months
|
21.6 score on a scale
Standard Deviation 21.9
|
22.9 score on a scale
Standard Deviation 15.2
|
Adverse Events
Immediate Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place