Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Daily Number of Minutes in Moderate/Vigorous Physical Activity
研究概览
简要总结
Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trial is to assess the efficacy of a Fitbit Flex (a wireless physical activity tracking device) paired with a new application, plus a brief education session and telephone counselling by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee osteoarthritis.
详细描述
Current practice guidelines emphasize the use of exercise and weight reduction as the first-line management of knee osteoarthritis (OA; affecting 1 in 10 Canadians). However, up to 90% of people with OA are inactive. Several modifiable risk factors are associated with low physical activity participation, including lack of motivation, doubts about the effectiveness of prescribed exercises and lack of health professional advice regarding ways to progress their physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active.
Our primary objective is to assess the efficacy of a Fitbit/Fitviz intervention, involving the use of a Fitbit Flex paired with a FitViz application (app), a brief education session, and telephone counselling by a physiotherapist, to improve physical activity participation and reduce sedentary time in people with knee OA. Our secondary objective is to assess the effect of the intervention on patients' OA disease status and self-efficacy in disease management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience; 2) To conduct a pilot test for the Fitbit/FitViz intervention; 3) To evaluate the effect of the Fitbit/FitViz intervention in patients with knee OA. 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) as determined by an objective measure, 2) reduce sedentary time during waking hours, 3) improve in OA disease status, and 4) improve in their self-efficacy of OA management.
The investigators will use a mixed-method 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), connective tissue diseases, or gout.
- •Have no history of using disease-modifying anti-rheumatic drugs, such as hydroxychloroquine, sulfasalazine, methotrexate, biologic agents (e.g., Humira, Enbrel), or gout medications.
- •Have no prior knee arthroplasty, 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, or ankle joints in the past 12 months.
- •Have an email address and use online/mobile applications.
- •Are able to attend one 1.5-hour education session.
排除标准
- •Have received a hyaluronate injection in a knee in the last 6 months.
- •Have received a steroid injection in a knee in the last 6 months.
- •Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire.
研究组 & 干预措施
Immediate Intervention Group
Education session, Fitbit/FitViz, PT counselling: Participants receive this intervention in Months 1-3. The session will include a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, and an orientation to the Fitbit Flex and the FitViz app. In Months 1 and 2, participants will use the Fitbit/FitViz. The PT will review the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities. In Month 3, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. In Months 4-9, participants may continue using the Fitbit/FitViz without access to a PT.
干预措施: Education session, Fitbit/FitViz, PT counselling (Behavioral)
Delayed Intervention Group
Same intervention with a 3 month delay: The full intervention will be initiated in Month 4 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physiotherapist. In Months 6-9, participants will continue using Fitbit/FitViz without the PT phone calls.
干预措施: Same intervention with a 3 month delay (Behavioral)
结局指标
主要结局
Daily Number of Minutes in Moderate/Vigorous Physical Activity
时间窗: Baseline, 13 weeks, 26 weeks, 39 weeks
Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.
次要结局
- Theory of Planned Behavior Questionnaire - Intention(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Daily Number of Sedentary Minutes(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life(Baseline, 13 weeks, 26 weeks, 39 weeks)
- The Patient Health Questionnaire-9 (PHQ-9)(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Partners in Health Scale(Baseline, Months 3, 6, and 9)
- Self-Reported Habit Index (SRHI) - Sitting at Work Subscale(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Self-Reported Habit Index (SRHI) - Walking Subscale(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Theory of Planned Behavior Questionnaire - Subjective Norm(Baseline, 13 weeks, 26 weeks, 39 weeks)
- Theory of Planned Behavior Questionnaire - Perceived Control(Baseline, 13 weeks, 26 weeks, 39 weeks)
研究者
Linda Li
Professor
University of British Columbia