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临床试验/NCT01608282
NCT01608282终止不适用

Capitalizing on the Teachable Moment: the OPEN (Osteoarthritis Physical Activity & Exercise Net) for Improving Physical Activity in Early Knee Osteoarthritis

University of British Columbia2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
75
试验地点
2
主要终点
Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).

研究概览

简要总结

OPEN (Osteoarthritis Physical Activity and Exercise Net) is a website created based on a well developed behavioural theory. This intervention is developed for people with early knee osteoarthritis (OA) who have been sedentary. The investigators aim to engage these individuals to become physically active at a time when their joint symptoms tend to be mild. The primary goal of this proof-of-concept randomized controlled trial is to determine if the OPEN website plus an information pamphlet about OA will improve participation in physical activity in persons with early knee OA, compared to those who receive only the pamphlet.

详细描述

Being physically active has been shown to reduce pain, improve quality of life and potentially reduce joint damage. However, our recent survey in British Columbia found only 1 in 4 people with mild osteoarthritis symptoms (pain; stiffness) met the recommended level of physical activity. Research in people without arthritis shows that web-based tools can increase walking behaviour, but none of these tools are designed with the needs of people with arthritis in mind. Research in other chronic diseases has found that people are more likely to quit smoking shortly after the diagnosis of a smoking-related disease. Thus, the diagnosis of osteoarthritis presents an ideal 'teachable moment' to engage those who have been sedentary to become physically active.

This project will address the Research Question: Can an interactive website increase physical activity in people with previously undiagnosed knee OA and those with a diagnosis of knee OA with no contraindication for being physically active? We have created a website, called OPEN (Osteoarthritis Physical Activity & Exercise Net), based on a well developed behavioural theory. A total of 252 sedentary people with knee osteoarthritis will be recruited in British Columbia to test the website. Half of them will be assigned to use the OPEN website for 3 months and will receive an education pamphlet produced by The Arthritis Society; the other half will only receive the pamphlet. During the test period, participants will complete an online questionnaire at 0, 3 and 6 months to allow us to follow changes in physical activity, knee symptoms and outcomes related to their motivation to become physically active. In addition,Participants will be stratified by OA diagnosis (having previously undiagnosed OA, as identified by a validated questionnaire, versus having a knee OA diagnosis). participants from Metro Vancouver who have previously undiagnosed knee OA will complete an aerobic fitness test administered by a blind assessor. Changes between the two groups will be compared.

Our project directly targets physical inactivity at a time when the joint damage tends to be mild, and when people are more motivated to adopt a healthy behaviour. If the OPEN is found to be effective in improving physical activity, it opens further opportunities to promote early diagnosis and to implement lifestyle interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have felt pain/discomfort in or around the knee during the previous year that lasted more than 28 separate or consecutive days.
  • Are 50 years or older.
  • Have not been physically active regularly (meaning, you have not participated in moderate intensity activities more than 90 minutes a week) in the past six months.
  • Have access to the internet.
  • Live in British Columbia.

排除标准

  • Have physician diagnosis of rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases or fibromyalgia.
  • Have a history of using disease-modifying anti-rheumatic drugs (DMARD) or gout medications.
  • Have had total knee replacement surgery or currently being considered for.
  • Have had any knee surgery within the past four months.
  • Have had acute injury to the knee in the past six months.
  • Have been using medication that may impair physical activity tolerance (e.g., beta blockers)
  • Are at other risks from exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q)

结局指标

主要结局

Modified Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).

时间窗: Change from baseline in levels of physical activity at 3 months and 6 months

Proportion of participants meeting the American College of Sports Medicine physical activity recommendation of 150 minutes or more of weekly physical activity (moderate or heavy intensity).

次要结局

  • Knee Injury and OA Outcome Score (KOOS).(Change from baseline in knee pain, stiffness, daily activity, sports/recreation and quality of life at 3 months and 6 months)
  • Rhode's 7-point Likert-type Theory of Planned Behaviour questionnaire(Change from baseline in motivation for physical activity at 3 months and 6 months)
  • Aerobic fitness (V02Peak)(Change from baseline in aerobic fitness at 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Li

Professor

University of British Columbia

研究点 (2)

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