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| Name | Class |
|---|---|
| Simon Fraser University | OTHER |
| 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 randomized controlled trail is to assess the efficacy of a physical activity counseling model, involving a group education session, the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee OA. Engaging in regular physical activity can have the additional benefit of improving cognitive functioning.
This project will address the Research Question: Can a non-intrusive physical activity tracking tool, combined with a group education session and advice from a physiotherapist (PT), increase physical activity in patients with knee osteoarthritis (OA)? The investigators focus on knee OA because it is common (affecting 1 in 10) and can be debilitating. Being physically active improves pain, mobility and quality of life; 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. Our primary objective is to determine whether a model involving 1) a group education session, 2) the use of Fitbit Flex, a commercially available physical activity tracker, and 3) remote coaching by a PT can improve physical activity and reduce sedentary time in patients with knee OA. This model of care is in line with the goal of Mary Pack Arthritis Program (MPAP) to optimize activity independence of OA patients with MPAP's available human resources. In this proof-of-concept randomized controlled trial (RCT), 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 in OA disease status, and 4) improve in their self-efficacy of OA management, 4) To examine whether individuals in the Intervention Group will show improved cognitive function over the intervention period compared to the control group, and 5) To examine the pre-intervention factors that predict the degree to which individuals in the Intervention Group increase MVPA and reduce sedentary time.
The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Experimental | 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 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity. |
|
| Delayed Intervention Group | Experimental | Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed. |
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| 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 called Fitbit Flex, and remote counseling 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 accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold. | Baseline; 2 months, 4 months and 6 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Sedentary Behaviors | We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of 20 minutes or more during waking hours. | Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months. |
| KOOS - Symptoms |
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Inclusion Criteria:
In addition, participants may be eligible (not required) to partake in a brain magnetic resonance imaging (MRI) assessment if they:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Li, PhD | Arthritis Research Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Research Canada | Richmond | British Columbia | V6X 2C7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30577819 | Derived | Falck RS, Best JR, Li LC, Chan PCY, Feehan LM, Liu-Ambrose T. Can we improve cognitive function among adults with osteoarthritis by increasing moderate-to-vigorous physical activity and reducing sedentary behaviour? Secondary analysis of the MONITOR-OA study. BMC Musculoskelet Disord. 2018 Dec 21;19(1):447. doi: 10.1186/s12891-018-2369-z. | |
| 29712630 |
| Label | URL |
|---|---|
| Study webpage | View source |
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After enrollment, participants completed the baseline assessment, and after completion of baseline participants were randomly assigned to the immediate group or the delayed group (ie, control) in 1:1 allocation ratio.
The recruitment period was from February 2015 - October 2016. Recruitment strategies included placing study advertisement material at Community Health Centres and Mary Pack Arthritis Centre. We also had study advertisement disseminated through Arthritis Research Canada website and group collaborators' group newsletters.
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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 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity. 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 called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately. |
| FG001 | Delayed Intervention Group | Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed. Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 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 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes 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; 2 months, 4 months and 6 months from baseline |
|
During the data collection for the randomized controlled trial, adverse event data was tracked using a monthly log (self-reported) by the 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 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity. 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 called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately. |
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Our sample was relatively active; hence, the results may not be generalizable to people with knee OA who are more sedentary. Also, the long-term effect of the intervention remained unclear.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Li, Professor, University of British Columbia | Arthritis Research Canada | 604-207-4020 | lli@arthritisresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2016 | Apr 3, 2019 | Prot_SAP_000.pdf |
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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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|
| Same intervention with a 2 month delay | Behavioral | The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay. |
|
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; 2 months, 4 months and 6 months from baseline |
| KOOS - Pain | Pain 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; 2 months, 4 months and 6 months from baseline |
| KOOS - Activity of Daily Living | Activity 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; 2 months, 4 months and 6 months from baseline |
| KOOS - Sports & Recreation | Sports & Recreation 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; 2 months, 4 months and 6 months from baseline |
| KOOS - 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; 2 months, 4 months and 6 months from baseline |
| Partners in Health Scale | The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. Scores range from 0 to 96, with lower being better. | Baseline; 2 months, 4 months and 6 months from baseline |
| Li LC, Sayre EC, Xie H, Falck RS, Best JR, Liu-Ambrose T, Grewal N, Hoens AM, Noonan G, Feehan LM. Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study. J Med Internet Res. 2018 Apr 30;20(4):e159. doi: 10.2196/jmir.8514. |
| BG001 | Delayed Intervention Group | Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Gross annual household income (CAN$) | Count of Participants | Participants |
|
| Diagnosed with OA | Count of Participants | Participants |
|
| In general would you say your health is... | Count of Participants | Participants |
|
| Compared to one year ago, how would you rate your health in general now? | Count of Participants | Participants |
|
| Number of comorbid conditions | Median | Inter-Quartile Range | Comorbid conditions |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Delayed Intervention Group | Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed. |
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| Secondary | Time Spent in Sedentary Behaviors | We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of 20 minutes or more 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 | Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months. |
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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; 2 months, 4 months and 6 months from baseline |
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| Secondary | KOOS - Pain | Pain 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; 2 months, 4 months and 6 months from baseline |
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| Secondary | KOOS - Activity of Daily Living | Activity 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; 2 months, 4 months and 6 months from baseline |
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| Secondary | KOOS - Sports & Recreation | Sports & Recreation 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; 2 months, 4 months and 6 months from baseline |
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| Secondary | KOOS - 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; 2 months, 4 months and 6 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 self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting 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; 2 months, 4 months and 6 months from baseline |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Delayed Intervention Group | Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed. Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay. | 0 | 31 | 0 | 31 | 0 | 31 |
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| Widowed/Never married/Other |
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| 24,001-40,000 |
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| 40,001-60,000 |
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| 60,001-80,000 |
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| 80,001-100,000 |
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| >100,000 |
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| No answer |
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| Good |
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| Fair |
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| Poor |
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| About the same |
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| Somewhat worse |
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| Much worse |
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| 4 months |
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| 6 months |
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| 4 months |
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| 6 months |
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| 4 months |
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| 6 months |
|
| 4 months |
|
| 6 months |
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| 4 months |
|
| 6 months |
|
| 4 months |
|
| 6 months |
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| 4 months |
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| 6 months |
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