Investigating the Effect of Interval Walking and Qigong on Some Clinical and Biological Outcomes of People With Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility measurement: recruitment, compliance, and dropout
研究概览
简要总结
Knee osteoarthritis (KOA) causes pain and limited function that leads to a sedentary lifestyle. The sedentary lifestyle increases the risk of cardiovascular diseases. In addition, many subjects with KOA have knee pain and sleep disturbance that limit their function, quality of life and cause body fatigue. Walking exercise can benefit people with KOA. However, continues walking for more than 30 minutes can increase pain that may stop people from participation in walking exercise.
Interval walking may complete the same amount of walking exercise in several separate time periods, without causing extra pain in people with KOA. Mind-body exercise may improve sleep and pain in people with KOA.
This study will help researchers to find out whether the interval walking, or mind-body exercise may help people with KOA to improve their pain, fitness level, sleep quality, exercise participation, fatigue, and quality of life.
By doing this study, researchers hope to learn more about the interval walking or mind-body exercise in people with KOA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are the following:
- •60-79 years of age and diagnosed with KOA by a physician or meet the ACR criteria (95% sensitivity, and 69% specificity) for KOA. The ACR criteria include experiencing almost daily knee pain and having at least 3 of these 6 criteria: (1) Age more than 50 years old, (2) less than 30 minutes of morning stiffness, (3) increased warmth of the knee, (4) crepitus with flexion or extension, (5) joints' bony enlargement , and (6) tenderness of joint line with palpation, or subject must be diagnosed radiologically, with grade II or more according to the Kellgren and Lawrence rating scale.
- •Frequent knee pain or aching on most of the preceding 30 days.
- •An average of mild to moderate pain intensity level (5 to 75 mm on the 100 mm VAS) in the last 7 days
- •Sedentary lifestyle assessed using 2011 Compendium of Physical Activities questionnaire. The subject is considered sedentary if engaging in exercise or physical activity with metabolic equivalents of task (MET) less than 4, not more than two times/week.
排除标准
- •Unwilling to attend 3 sessions/week at Kirmayer Fitness Center
- •Having other types of arthritis such as rheumatoid arthritis or gout
- •Neurological disorders
- •CVD including hypertension that prevent them from engaging in walking exercise
- •Currently using beta blocker medication
- •Underwent any lower limb surgery during the past 6 months
- •A history of two or more incidents of fall during the last 6 months
- •Current hip or spine pain that prevents them from engaging in walking exercise.
研究组 & 干预措施
interval group
干预措施: Interval walking and Qigong exercise (Behavioral)
Qigong exercise
干预措施: Interval walking and Qigong exercise (Behavioral)
continuous walking
干预措施: Interval walking and Qigong exercise (Behavioral)
结局指标
主要结局
Feasibility measurement: recruitment, compliance, and dropout
时间窗: 6 week
Feasibility will be quantified using rates of participant recruitment, compliance, and dropout rate from the exercise program using exercise diary filled by the exercise supervisor. The Percentage of recruited subjects per month will be reported. The dropout rate is defined as the percentage of subjects who do not complete the study intervention and choose to withdraw. The compliance is defined as the percentage of the completed exercise program. The exercise diary log of subjects who drop out of the study will not be included when compliance is calculated. (feasibility measures will be reported in percentage)
Acceptability
时间窗: 6 week
Acceptability will be assessed via participants' program evaluation scores and rating of treatment satisfaction at the end-intervention evaluation. The subjects will be asked to score, on an 11-point scale, ranging from 0 (poor) to 10 (excellent) for questions "How do you rate this exercise program overall in regarding to ease of use?" and "How do you rate this exercise program overall in regarding to improving your symptoms?" Participants will be also asked to rate their overall level of satisfaction with the intervention using an 11-point numerical rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
次要结局
- Comprehensive pain assessment: the Measure of Intermittent and Constant Osteoarthritis Pain(6 week)
- Blood pressure(6 week)
- Fatigue: Multidimensional Fatigue Inventory (MFI-20)(6 week)
- Heart rate variability (HRV)(6 week)
- Sleeping Quality: Pittsburgh Sleep Quality Index(6 week)
- Depression: Geriatric Depression Scale(6 week)
- Fitness level- The 6-minute walk test(6 week)
- Pain intensity measurement(6-week)
- Resting heart rate (rHR) and heart rate recovery (HRR)(6 week)
- insomnia severity(6 week)
- 36 short form Quality of Life(6 week)
- Inflammatory biomarkers(6 week)
- Knee Injury and Osteoarthritis Outcome Score(6 week)