A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Absolute Value of OA Symptoms at 8 Weeks
研究概览
简要总结
The study hypothesized that it is feasible and safe to use Hatha yoga in older women with knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and stiffness, enhance physical function, and improve quality of sleep and quality of life in older women with knee OA.
详细描述
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Potential participants were initially screened via telephone by a trained research assistant for eligibility which was based on the following inclusion criteria:
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community-dwelling women aged 65 years or over;
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had a symptomatic OA of knee diagnosis for at least 6 months;
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had no previous training in any form of yoga; and
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were not currently participating in a supervised exercise program.
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Once initial screening eligibility was established, the individual was seen at home to confirm:
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the presence of knee OA symptoms using the Clinical Criteria for the Classification of Idiopathic OA of the Knee developed by the American College of Rheumatology.
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Cognitively intact using the Short Portable Mental Status Questionnaire (SPMSQ).
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Exclusion criteria included:
- symptoms of joint locking;
- instability indicated by chronic use of a knee brace, cane, walker, or wheelchair;
- a corticosteroid injection in the symptomatic joint within three months of study entry;
- a hyaluronic acid injection in the symptomatic joint within six months of study entry;
- a history of knee surgery within the last two years or a joint replacement at any point;
- individuals who had self-reported significant medical comorbidities that might preclude exercise participation such as: a) uncontrolled high blood pressure or existing heart condition; and b) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis);
- individuals who had medication changes for arthritis symptoms were permitted to remain in the trial; however, these changes were monitored.
- Primary outcome measures included:
- OA symptoms (e.g., pain, stiffness and physical function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1) (WOMAC) and a single question that asked about the number of pain medications used per day.
- WOMAC scale contains 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The 5-point Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. Higher values represent a worse OA symptom.
- Secondary outcome measures included:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 86 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •community-dwelling women aged 65 years or over
- •had a symptomatic OA of knee diagnosis for at least 6 months
- •had no previous training in any form of yoga; and
- •were not currently participating in a supervised exercise program
- •cognitively intact
排除标准
- •symptoms of joint locking;
- •instability indicated by chronic use of a knee brace, cane, walker, or wheelchair;
- •a corticosteroid injection in the symptomatic joint within three months of study entry;
- •a hyaluronic acid injection in the symptomatic joint within six months of study entry;
- •a history of knee surgery within the last two years or a joint replacement at any point;
- •individuals who had self-reported significant medical comorbidities that might preclude exercise participation such as: a) uncontrolled high blood pressure or existing heart condition; and b) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis) were also be excluded.
结局指标
主要结局
Absolute Value of OA Symptoms at 8 Weeks
时间窗: 8 weeks
Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Absolute Value of OA Pain at 8 Weeks
时间窗: 8 weeks
A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.
次要结局
- Absolute Value of Quality of Sleep at 8 Weeks(8 weeks)
- Absolute Value of Quality of Life at 8 Weeks(8 weeks)
- Absolute Value of BMI at 8 Weeks(8 weeks)
- Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks(8 weeks)