Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
Evaluate the effect of manual diaphragmatic release on exercise capacity, inspiratory muscles strength, symptoms severity, and health-related quality of life in women diagnosed with fibromyalgia.
详细描述
Sixty women diagnosed with fibromyalgia will be recruited from outpatient rheumatology and physical therapy clinics. Following clinical screening, patients will be randomly assigned into two parallel groups:
The Study Group: Will include 30 women participating in manual diaphragmatic release plus aerobic training for 8 weeks.
The Control Group: Will include 30 women participating in aerobic training only for 8 weeks.
At baseline and post-study (after 8 weeks), outcomes will be comprehensively assessed. The primary focus is to determine whether manual release of the diaphragm improves exercise capacity, minimizes the overall impact of fibromyalgia symptoms, improves health-related quality of life metrics, and enhances respiratory muscles strength.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of fibromyalgia fulfilling the American College of Rheumatology diagnostic criteria.
- •Sedentary or low physical activity status (not participating in structured exercise programs within the past 3 months).
排除标准
- •Severe psychiatric comorbidities (e.g., major depressive disorder with active suicidal ideation) or cognitive impairments.
- •Presence of comorbid rheumatologic or autoimmune conditions that overlap with muscle/joint symptoms (e.g., severe rheumatoid arthritis, systemic lupus erythematosus).
- •Primary chronic respiratory/chest diseases (e.g., severe COPD or active asthma).
- •Cardiovascular disorders or uncontrolled hypertension.
- •Pregnancy.
研究者
Saher Lotfy El Gayar
Assistant Professor of Physical Therapy
Middle East University