Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change from baseline in analogue scale (VAS) score at week 12
研究概览
简要总结
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.
详细描述
Objective
To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.
Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).
Study Type: Interventional (Clinical Trial)
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
- •Participants were well communicative, motivated, and willing to participate in the study.
排除标准
- •The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.
结局指标
主要结局
Change from baseline in analogue scale (VAS) score at week 12
时间窗: Week 12
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
时间窗: Week 12
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
时间窗: Week 12
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Change from baseline in Short Form 36 (SF-36) score at week 12.
时间窗: Week 12
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Change from baseline in weight (kilograms) at week 12.
时间窗: Week 12
Weight was measured with body composition analyzer (Tanita MC580).
Change from baseline in body mass index (BMI) at week 12
时间窗: Week 12
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Change from baseline in total body fat percentage at week 12
时间窗: Week 12
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in in total body muscle percentage at week 12.
时间窗: Week 12
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
时间窗: Week 12
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
次要结局
未报告次要终点
研究者
Füsun Ardıç
Director, Head of Physical Medicine and Rehabilitation, Principal Investigator, Clinical Professor
Pamukkale University