Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Westerm Ontário and McMaster Universities
研究概览
简要总结
Physical exercise is a widely recommended treatment modality for osteoarthritis, which can be performed through a supervised group exercise or a home exercise program. However, up to now only little research has been conducted on the home exercise program in Brazil. The objective of this study is to compare the efficacy between supervised group exercise and home exercise program in people with knee osteoarthritis. Methods: The study population consists of 46 men and woman with knee osteoarthritis aged between 40 and 65. The patients should be clinically diagnosed with knee osteoarthritis and classified in Kelgreen-Laurence grades I, II and III. Primary outcomes are the Westerm Ontário and McMaster Universities (WOMAC), Lower Extremity Functional Scale (LEFS), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia, 40-meter walk test, isometric strength of hip (abduction and adduction) and knee (flexion and extension) and postural control. The patients are randomized into 2 groups, with one group receiving 12 sessions of supervised group exercise and the other group following an exercise program at home. The program lasts 6 weeks with both groups receiving the same exercise protocol consisting of stretching, isometric and isotonic exercises for major muscle groups in both lower extremities. The Mann-Whitney U test is used to examine the Anthropometric variables. The ANOVA is used to compare outcomes before and after treatment. A value of p< 0.05 is considered to be statistically signifcant.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 45 and 65 years;
- •Kellgren-Lawrence Grade I, II and III with knee osteoarthritis determined clinically and radiographically.
排除标准
- •history of surgery in the lower limb;
- •patients who performed physiotherapy in the last six months;
- •disease or disability which contraindicate the performance of the exercise training (vestibular problems, cardiorespiratory, rheumatic and neurological diseases).
研究组 & 干预措施
Supervised group exercise
The supervised exercise group will receive a lower extremity exercise treatment, under physiotherapist supervision for 60 min, two times a week (12 sessions).
干预措施: Supervised group exercise (Other)
Home-based exercise
For the home-based exercise group, exercises will be demonstrated to the patient with the supervision and guidance of a physiotherapist in an exercise session. These patients will perform the same exercise protocol at home at least twice a week.
In addition to the initial session, subjects will perform further two supervised sessions (at one week and four weeks after the initial session).
The exercise program are the same as the supervised group exercise.
干预措施: Home-based exercise (Other)
结局指标
主要结局
Westerm Ontário and McMaster Universities
时间窗: 15 min
The Westerm Ontário and McMaster Universities (WOMAC) questionnaire is a multidimensional measure of pain, stiffness, and physical functional disability in patients with osteoarthritis. In this study we will use the Visual Analogue Scale format with 24 items and five response levels for each item (none- 0 points, mild-25, moderate-50, severe-75 or extreme-100 points). The range of the scores is function (0-1700), pain (0-500) and stiffness (0-200) and the final score of each item is obtained by dividing the final result by the number of questions of each item. The total score is obtained by adding all the items and dividing by 24. Scores range from 0 to 100 for the total WOMAC, where 0 represents the best health status and 100 the worst possible status. The higher the score, the poorer the function.
次要结局
- Isometric strength of hip and knee(35 min.)
- Pain Catastrophizing Scale (PCS)(10 min)
- Body Mass Index(5 min.)
- Tampa Scale for Kinesiophobia(10 min)
- Lower Extremity Functional Scale(10 min)
- 40-meter walk test(2 min)
- Postural control(30 min.)
研究者
Michele Forgiarini Saccol
Professor of Physical Therapy and Rehabilitation's Department
Universidade Federal de Santa Maria