A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in pain
研究概览
简要总结
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Objective: To evaluate the effectiveness of a program of functional exercises in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. Intervention: The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group will perform stretching exercises with the same duration and frequency. evaluation instruments: Visual Analog Scale for pain; Fibromyalgia Impact Questionnaire; Time-up and go test; 1Repetitian Maximum test; Sit and reach test; Berg Balance Scale; and Short Form-36 and amount of analgesics used during the intervention period was evaluated.
详细描述
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and the functional capacity of patients. There is growing evidence of the benefits of exercise to improve fibromyalgia symptoms, making these interventions part of the therapeutic arsenal. Objective: To evaluate the effectiveness of a functional exercise program in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. METHODS: This was a randomized controlled trial with blind evaluator. 82 female patients with fibromyalgia were included, aged between 18 and 65 years, randomized into two groups, intervention and control. The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group performed stretching exercises with the same duration and frequency. The evaluation instruments were: Visual Analog Scale for pain evaluation; Fibromyalgia Impact Questionnaire, to evaluate health-related quality of life; Time-up and go test for functional performance assessment; 1Repetitium Maximum, for evaluation of muscle strength; sit and reach test for the assessment of flexibility; Berg Balance Scale, to assess balance; and Short Form-36 to assess overall quality of life. In addition, the amount of analgesics used during the intervention period was evaluated.
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)
盲法说明
Randomised electronically generated randomisation table. Secret allocation (sealed opaque envelopes).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Classification of fibromyalgia based on the criteria of the American College of Rheumatology
- •Age 18 to 65 years;
- •Pain intensity between 4 and 8cm on a visual analog scale ranging from 0 to 10cm
- •Stable medication for at least three months
排除标准
- •Uncontrolled cardiorespiratory disease
- •Health condition for which physical exercise was contraindicated
- •Serious psychiatric disorder
- •Uncontrolled diabetes mellitus
- •Inflammatory rheumatic disease
- •History of regular physical exercise (30min, 3 times a week) in the previous 3 months
结局指标
主要结局
Change in pain
时间窗: Baseline, after 7, 14, 26 and 38 weeks
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.
次要结局
- Change in functional performance(Baseline, after 7, 14, 26 and 38 weeks)
- Change in balance(Baseline, after 7, 14, 26 and 38 weeks)
- Change in health-related quality of life(Baseline, after 7, 14, 26 and 38 weeks)
- Change in Flexibility(Baseline, after 7, 14, 26 and 38 weeks)
- Change in medications consumption(Baseline, after 7, 14, 26 and 38 weeks)
- Change in Muscular Strength(Baseline, after 7, 14, 26 and 38 weeks)
- Change in General quality of life(Baseline, after 7, 14, 26 and 38 weeks)
研究者
Giovana Fernandes
PhD Student
Federal University of São Paulo