Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Osteoarthritis (OA) symptoms change
研究概览
简要总结
The purpose of the study is to examine the short and long term effects of Hatha yoga compared to the current recommended exercise program in promoting physical function, alleviating osteoarthritis (OA)-related symptoms, fear of falling, and improving mood, spiritual health, physical activity level, and quality of life in older adults with knee OA, and to determine the effect sizes for use in power calculations to design a larger efficacy clinical trial.
详细描述
The specific aims of this pilot project are to:
Aim 1: Examine the short and long term effect of participation in an 8-week intervention of Hatha yoga (HY) on pain, stiffness, physical function of the lower extremities, physical activity, mood, fear of falling, spiritual health, and quality of life in older women with knee OA, compared with the effect in those older adults who participated in aerobic/strengthening exercise (AE) or received general OA education (GE).
Aim 2: Describe the adherence rate (class and home practices) and exercise acceptability of the HY and AE programs.
A randomized controlled trial design with three groups were used: 1) A Hatha yoga (HY) intervention group, 2) an aerobic and local muscle strengthening exercise (AE) control group, and 3) a general OA education (GE) true control group. Both yoga and exercise groups involved group and home practice sessions. Participants in the GE group received education on OA management after randomization. A weekly phone call were placed to them during the intervention period to reinforce OA knowledge. Data were collected from all participants at baseline, 4 weeks, and 8 weeks during the intervention, and quarterly for one year during the follow up period.
Study Endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have been diagnosed with symptomatic OA of knee for at least 6 months,
- •have not practiced any form of yoga for at least 2 months; and
- •not currently participating in a supervised exercise program. "Currently" is defined as not participating in a supervised exercise program more than 2 times a week at the time of second-step screening.
排除标准
- •OA is asymptomatic,
- •have moderate/severe cognitive impairment, scored less than 8 on the Short Portable Mental Status Questionnaire,
- •have cardiovascular risk,
- •reported symptoms of joint locking,
- •instability indicated by chronic use of a knee brace, cane, walker, or wheelchair,
- •corticosteroid injection in the symptomatic joint within 3 months of study entry,
- •hyaluronic acid injection: hyaluronan (Hyalgan) and synthetic hylan G-F 20 (Synvisc) in the symptomatic joint within 6 months of study entry,
- •history of knee surgery within the last two years, arthroscopic lavage within 6 months, or a joint replacement of the lower extremities at any point,
- •self-reported significant medical comorbidities such as: 1) uncontrolled high blood pressure or existing heart condition; and 2) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis),
- •Individuals who have medication changes for arthritis symptoms will be permitted to remain in the trial; however, these changes will be monitored.
研究组 & 干预措施
Yoga Group
Participants in the yoga group received a total of eight weekly 45 minute yoga classes. A sequence of 8 - 10 core yoga poses, breathing and relaxation techniques were practiced in each yoga class, and 2 - 3 new poses were introduced progressively in each of the yoga session. Props such as blocks, blankets, belts, mats, and chairs were used during the session. Handouts were provided for participants to practice the yoga program for additional 30 minutes a day, 4 days a week at home.
干预措施: Hatha yoga (Other)
Aerobic and Strengthening Exercise Group
Participants in the exercise group received a total of eight weekly 45 minute exercise classes. A 15 minute of gentle aerobic exercise and a 30 minute of strengthening program that includes both isometric (without moving the joints) and isotonic (moving the joints) exercises of the lower extremities were taught to the participants. Handouts were provided for participants to practice the program at home for 30 minutes a day, 3 days a week (on non-consecutive days).
干预措施: Aerobic and strengthening exercises (Other)
General education
Participants in this group received a one-time OA educational brochures from the Arthritis Foundation including topics focusing on the disease process, diet and exercise and OA management education. Participants were instructed not to begin any new exercise programs during the study period.
干预措施: General education (Other)
结局指标
主要结局
Osteoarthritis (OA) symptoms change
时间窗: Change from baseline OA symtptoms at 8 weeks
OA pain, stiffness and function (total score) is evaluated using the Western Ontario and McMaster Universities OA (WOMAC) index scale.
Knee OA pain change
时间窗: Change from baseline number of medication used per day for OA pain at 8 weeks
Number of pain medication used per day for OA pain
次要结局
- Gait speed(4 and 8 weeks)
- Physical activity level(4 and 8 weeks)
- Spiritual health(4 and 8 weeks)
- Quality of life(4 and 8 weeks)
- Mood(4 and 8 weeks)
- Fear of falling(4 and 8 weeks)
- Physical function(4 and 8 weeks)