Joint Diseases, Knee Osteoarthritis
Conditions
Keywords
Physical activity, Exercise, Osteoarthritis, Knee, Arthritis
Brief summary
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.
Detailed description
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.
Interventions
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.
BEHAVIORALSame 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.
Sponsors
Arthritis Research Centre of Canada
Vancouver General Hospital
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study used a delayed control design.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50, and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee during the last year (equal to or more than 28 separate or consecutive days). * Have no previous diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout. * Have no history of using disease-modifying anti-rheumatic drugs or gout medications. * Have no prior knee replacement surgery, and not on a waiting list for total knee replacement surgery. * Have no history of acute injury to the knee in the past 6 months. * Have not had surgery in the back, hip, knee, foot or ankle joints in the past 12 months. * Have an email address and daily access to a computer with internet connection. * Be able to attend a 2-hour education session at the Mary Pack Arthritis Centre.
Exclusion criteria
* Have a body mass index of equal to or greater than 40 * Have received a steroid injection in a knee in the last 6 months * Have received a hyaluronate injection in a knee in the last 6 months * Use medication that may impair activity tolerance (e.g. beta blockers) * Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire (PAR-Q)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | Baseline; 1 month and 2 months from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS - Symptoms | Baseline; 1 month and 2 months from baseline | 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. |
| KOOS - Pain | Baseline; 1 month and 2 months from baseline | Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better. |
| KOOS - Activities of Daily Living | Baseline; 1 month and 2 months from baseline | 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. |
| Time Spent in Sedentary Behavior | Baseline; 1 month and 2 months from baseline | 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. |
| KOOS - Knee-related Quality of Life | Baseline; 1 month and 2 months from baseline | 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. |
| Partners in Health Scale | Baseline; 1 month and 2 months from baseline | 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. |
| KOOS - Sport and Recreation Function | Baseline; 1 month and 2 months from baseline | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Total | Delayed Intervention Group | Immediate Intervention Group |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 8.6 | 58.7 years STANDARD_DEVIATION 6 | 52.3 years STANDARD_DEVIATION 9.7 |
| Body Mass Index | 27.2 kg/m^2 STANDARD_DEVIATION 4.7 | 25.4 kg/m^2 STANDARD_DEVIATION 4.2 | 29.1 kg/m^2 STANDARD_DEVIATION 4.5 |
| Comorbid conditions | 2.5 comorbid conditions | 2 comorbid conditions | 3 comorbid conditions |
| Compared to one year ago, how would you rate your health in general? About the same | 27 Participants | 12 Participants | 15 Participants |
| Compared to one year ago, how would you rate your health in general? Much better | 1 Participants | 0 Participants | 1 Participants |
| Compared to one year ago, how would you rate your health in general? Much worse | 0 Participants | 0 Participants | 0 Participants |
| Compared to one year ago, how would you rate your health in general? Somewhat better | 1 Participants | 1 Participants | 0 Participants |
| Compared to one year ago, how would you rate your health in general? Somewhat worse | 5 Participants | 4 Participants | 1 Participants |
| Diagnosed with OA No, but met the 'likely OA' criteria | 14 Participants | 8 Participants | 6 Participants |
| Diagnosed with OA Yes | 20 Participants | 9 Participants | 11 Participants |
| Gross annual household income $12,001 - $24,000 | 1 Participants | 1 Participants | 0 Participants |
| Gross annual household income $24,001 - $40,000 | 2 Participants | 2 Participants | 0 Participants |
| Gross annual household income $40,001 - $60,000 | 5 Participants | 1 Participants | 4 Participants |
| Gross annual household income $60,001 - $80,000 | 0 Participants | 0 Participants | 0 Participants |
| Gross annual household income $80,001 - $100,000 | 3 Participants | 1 Participants | 2 Participants |
| Gross annual household income No answer | 7 Participants | 4 Participants | 3 Participants |
| Gross annual household income Over $100,000 | 14 Participants | 7 Participants | 7 Participants |
| Gross annual household income Under $12,000 | 2 Participants | 1 Participants | 1 Participants |
| In general, would you say your health is ... Excellent | 6 Participants | 1 Participants | 5 Participants |
| In general, would you say your health is ... Fair | 4 Participants | 1 Participants | 3 Participants |
| In general, would you say your health is ... Good | 13 Participants | 9 Participants | 4 Participants |
| In general, would you say your health is ... Poor | 0 Participants | 0 Participants | 0 Participants |
| In general, would you say your health is ... Very good | 11 Participants | 6 Participants | 5 Participants |
| Marital Status Married/Common Law | 25 Participants | 14 Participants | 11 Participants |
| Marital Status Separated/ Divorced | 5 Participants | 1 Participants | 4 Participants |
| Marital Status Widowed/ Never Married/ Other | 4 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Canada | 34 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 28 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | Baseline | 41.3 Minutes per day | Standard Deviation 51.6 |
| Immediate Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 1 Month | 64.2 Minutes per day | Standard Deviation 70.5 |
| Immediate Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 2 Months | 67.7 Minutes per day | Standard Deviation 85.8 |
| Delayed Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | Baseline | 66.5 Minutes per day | Standard Deviation 71 |
| Delayed Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 1 Month | 56.0 Minutes per day | Standard Deviation 60.1 |
| Delayed Intervention Group | Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | 2 Months | 81.9 Minutes per day | Standard Deviation 64.4 |
Comparison: ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.p-value: 0.0295% CI: [-56.6, -5.7]ANCOVA
Comparison: ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.p-value: 0.7195% CI: [-19.6, 28.9]ANCOVA
Comparison: ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.p-value: 0.2995% CI: [-31.1, 9.1]ANCOVA
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | KOOS - Activities of Daily Living | Baseline | 81.8 score on a scale | Standard Deviation 17.1 |
| Immediate Intervention Group | KOOS - Activities of Daily Living | 1 Month | 75.1 score on a scale | Standard Deviation 19.7 |
| Immediate Intervention Group | KOOS - Activities of Daily Living | 2 Months | 83 score on a scale | Standard Deviation 14.9 |
| Delayed Intervention Group | KOOS - Activities of Daily Living | Baseline | 78.3 score on a scale | Standard Deviation 15.9 |
| Delayed Intervention Group | KOOS - Activities of Daily Living | 1 Month | 79.1 score on a scale | Standard Deviation 18.9 |
| Delayed Intervention Group | KOOS - Activities of Daily Living | 2 Months | 82.2 score on a scale | Standard Deviation 17.1 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | KOOS - Knee-related Quality of Life | Baseline | 53.3 score on a scale | Standard Deviation 18.4 |
| Immediate Intervention Group | KOOS - Knee-related Quality of Life | 1 Month | 51.8 score on a scale | Standard Deviation 19.5 |
| Immediate Intervention Group | KOOS - Knee-related Quality of Life | 2 Months | 56.6 score on a scale | Standard Deviation 20.2 |
| Delayed Intervention Group | KOOS - Knee-related Quality of Life | Baseline | 47.4 score on a scale | Standard Deviation 16.1 |
| Delayed Intervention Group | KOOS - Knee-related Quality of Life | 1 Month | 48.9 score on a scale | Standard Deviation 19.3 |
| Delayed Intervention Group | KOOS - Knee-related Quality of Life | 2 Months | 52.3 score on a scale | Standard Deviation 18 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | KOOS - Pain | 1 Month | 71.4 score on a scale | Standard Deviation 17.5 |
| Immediate Intervention Group | KOOS - Pain | 2 Months | 79.1 score on a scale | Standard Deviation 13 |
| Immediate Intervention Group | KOOS - Pain | Baseline | 74.5 score on a scale | Standard Deviation 16.2 |
| Delayed Intervention Group | KOOS - Pain | Baseline | 68.6 score on a scale | Standard Deviation 16.1 |
| Delayed Intervention Group | KOOS - Pain | 1 Month | 71.6 score on a scale | Standard Deviation 15.2 |
| Delayed Intervention Group | KOOS - Pain | 2 Months | 74 score on a scale | Standard Deviation 15.4 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | KOOS - Sport and Recreation Function | Baseline | 55.6 score on a scale | Standard Deviation 29.5 |
| Immediate Intervention Group | KOOS - Sport and Recreation Function | 1 Month | 54.7 score on a scale | Standard Deviation 28.3 |
| Immediate Intervention Group | KOOS - Sport and Recreation Function | 2 Months | 64.4 score on a scale | Standard Deviation 28.4 |
| Delayed Intervention Group | KOOS - Sport and Recreation Function | Baseline | 51.2 score on a scale | Standard Deviation 26 |
| Delayed Intervention Group | KOOS - Sport and Recreation Function | 1 Month | 54.4 score on a scale | Standard Deviation 31.4 |
| Delayed Intervention Group | KOOS - Sport and Recreation Function | 2 Months | 55.6 score on a scale | Standard Deviation 22.6 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | KOOS - Symptoms | Baseline | 70.6 score on a scale | Standard Deviation 15.8 |
| Immediate Intervention Group | KOOS - Symptoms | 1 Month | 68.3 score on a scale | Standard Deviation 18.4 |
| Immediate Intervention Group | KOOS - Symptoms | 2 Months | 72.5 score on a scale | Standard Deviation 20.2 |
| Delayed Intervention Group | KOOS - Symptoms | Baseline | 70.4 score on a scale | Standard Deviation 14.9 |
| Delayed Intervention Group | KOOS - Symptoms | 1 Month | 66.8 score on a scale | Standard Deviation 18.2 |
| Delayed Intervention Group | KOOS - Symptoms | 2 Months | 73.2 score on a scale | Standard Deviation 15.4 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Partners in Health Scale | Baseline | 21.9 score on a scale | Standard Deviation 17.6 |
| Immediate Intervention Group | Partners in Health Scale | 1 Month | 17.2 score on a scale | Standard Deviation 17 |
| Immediate Intervention Group | Partners in Health Scale | 2 Months | 21.6 score on a scale | Standard Deviation 21.9 |
| Delayed Intervention Group | Partners in Health Scale | Baseline | 26.8 score on a scale | Standard Deviation 15.3 |
| Delayed Intervention Group | Partners in Health Scale | 1 Month | 31.9 score on a scale | Standard Deviation 17.9 |
| Delayed Intervention Group | Partners in Health Scale | 2 Months | 22.9 score on a scale | Standard Deviation 15.2 |
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.
Time frame: Baseline; 1 month and 2 months from baseline
Population: The number of participants analyzed is the same as the number of participants assigned to each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Time Spent in Sedentary Behavior | Baseline | 548.4 Minutes per day | Standard Deviation 169.1 |
| Immediate Intervention Group | Time Spent in Sedentary Behavior | 1 Month | 524.9 Minutes per day | Standard Deviation 192.1 |
| Immediate Intervention Group | Time Spent in Sedentary Behavior | 2 Months | 523.9 Minutes per day | Standard Deviation 200.2 |
| Delayed Intervention Group | Time Spent in Sedentary Behavior | Baseline | 453.3 Minutes per day | Standard Deviation 180.5 |
| Delayed Intervention Group | Time Spent in Sedentary Behavior | 1 Month | 492.8 Minutes per day | Standard Deviation 164.8 |
| Delayed Intervention Group | Time Spent in Sedentary Behavior | 2 Months | 393.1 Minutes per day | Standard Deviation 144.2 |