Feasibility and Preliminary Efficacy of an Activity Tracker-driven Intervention for Promoting Physical Activity in People Living With Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
研究概览
简要总结
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.
详细描述
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.
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
入排标准
- 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 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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Education session, Fitbit Flex, and remote coaching by a PT (Behavioral)
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.
干预措施: Same intervention with a 1 month delay (Behavioral)
结局指标
主要结局
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
时间窗: 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.
次要结局
- Time Spent in Sedentary Behavior(Baseline; 1 month and 2 months from baseline)
- KOOS - Symptoms(Baseline; 1 month and 2 months from baseline)
- KOOS - Pain(Baseline; 1 month and 2 months from baseline)
- KOOS - Activities of Daily Living(Baseline; 1 month and 2 months from baseline)
- KOOS - Sport and Recreation Function(Baseline; 1 month and 2 months from baseline)
- KOOS - Knee-related Quality of Life(Baseline; 1 month and 2 months from baseline)
- Partners in Health Scale(Baseline; 1 month and 2 months from baseline)
研究者
Linda Li
Professor
University of British Columbia