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| Name | Class |
|---|---|
| Arthritis Research Centre of Canada | OTHER |
| Vancouver General Hospital | OTHER |
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Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150 minutes or more per week. The primary goal of this pilot randomized controlled trail is to assess the feasibility and preliminary efficacy of a multi-component intervention/model of care involving a group education session, use of the Fitbit Flex (a wireless physical activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to improve physical activity and reduce sedentary time in patients with knee OA.
Knee osteoarthritis (OA) is common (affecting 1 in 10), painful, and debilitating. Being physically active improves pain, mobility and quality of life for people living with knee OA; however, less than half of patients are active. Combining the best evidence in OA care and digital technology, the investigators propose a new model of care for improving physical activity in patients with OA.
The investigators primary objective is to determine the feasibility and preliminary efficacy of a multi-component model of care involving 1) a group education and structured goal-setting session, 2) the use of Fitbit Flex (a commercially available physical activity tracker) and 3) weekly telephone activity counselling by a physiotherapist for improving physical activity and reducing sedentary time in patients with knee OA.
In this pilot randomized controlled trial the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve OA disease status, and 4) improve abilities to self-manage their condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Active Comparator | 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. |
|
| Delayed Intervention Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education session, Fitbit Flex, and remote coaching by a PT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 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. | Baseline; 1 month and 2 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Sedentary Behavior | 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. | Baseline; 1 month and 2 months from baseline |
| KOOS - Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Li, PT, PhD | Arthritis Research Canada; University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Research Canada | Richmond | British Columbia | V6X 2C7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28652228 | Derived | Li LC, Sayre EC, Xie H, Clayton C, Feehan LM. A Community-Based Physical Activity Counselling Program for People With Knee Osteoarthritis: Feasibility and Preliminary Efficacy of the Track-OA Study. JMIR Mhealth Uhealth. 2017 Jun 26;5(6):e86. doi: 10.2196/mhealth.7863. | |
| 27965808 | Derived | Clayton C, Feehan L, Goldsmith CH, Miller WC, Grewal N, Ye J, Yoo JY, Li LC. Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol. Pilot Feasibility Stud. 2015 Aug 22;1:30. doi: 10.1186/s40814-015-0027-x. eCollection 2015. |
| Label | URL |
|---|---|
| Study webpage | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | Minutes per day | Baseline; 1 month and 2 months from baseline |
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Adverse events were tracked using a monthly log (self-reported) over the duration of the study (6 months) for each participant.
We tracked self-reported adverse events (falls, cardiovascular and musculoskeletal events).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Our sample was physically active at baseline. Also, the majority of our participants were women. Men and women may respond to behavioral interventions differently, but we are unable to examine the effect of sex on the outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Li | Arthritis Research Canada | 604-207-4020 | lli@arthritisresearch.ca |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| D009043 | Motor Activity |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |
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This study used a delayed control design.
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| Same intervention with a 1 month delay | Behavioral | The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay. |
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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.
| Baseline; 1 month and 2 months from baseline |
| KOOS - Pain | Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better. | Baseline; 1 month and 2 months from baseline |
| KOOS - Activities of Daily Living | 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. | Baseline; 1 month and 2 months from baseline |
| KOOS - Sport and Recreation Function | 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. | Baseline; 1 month and 2 months from baseline |
| KOOS - Knee-related Quality of Life | 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. | Baseline; 1 month and 2 months from baseline |
| Partners in Health Scale | 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. | Baseline; 1 month and 2 months from baseline |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Marital Status | Count of Participants | Participants |
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| Gross annual household income | Count of Participants | Participants |
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| Diagnosed with OA | Count of Participants | Participants |
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| In general, would you say your health is ... | Count of Participants | Participants |
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| Compared to one year ago, how would you rate your health in general? | Count of Participants | Participants |
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| Comorbid conditions | Median | Inter-Quartile Range | comorbid conditions |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| OG001 | 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. |
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| Secondary | Time Spent in Sedentary Behavior | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | Minutes per day | Baseline; 1 month and 2 months from baseline |
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| Secondary | KOOS - Symptoms | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| Secondary | KOOS - Pain | Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| Secondary | KOOS - Activities of Daily Living | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| Secondary | KOOS - Sport and Recreation Function | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| Secondary | KOOS - Knee-related Quality of Life | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| Secondary | Partners in Health Scale | 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. | The number of participants analyzed is the same as the number of participants assigned to each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1 month and 2 months from baseline |
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| EG001 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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