About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Manual Diaphragmatic Release
Other interventionThrice a week for 8 weeks, the participant will assume a supine position with relaxed limbs. The therapist will position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. During the inspiratory phase, the therapist gently pulls the contact points toward the head and slightly laterally, progressively deepening contact within the costal margin over successive respiratory cycles to release restriction.
Aerobic Training
Other intervention3 sessions per week consisting of 30-45 minutes of cycling at low-to-moderate intensity on a cycle ergometer. Intensity will be managed at a workout heart rate ranging between 60% to 70% of the maximal heart rate, accompanied by a brief warm-up and cool-down phase.
Treatment groups
Trial outcomes
Primary outcomes
Exercise Capacity
Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing
Secondary outcomes
Health-Related Quality of Life
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The survey provides scores for physical and mental health status, with scores ranging from 0 to 100, where higher scores indicate better health-related quality of life.
Fibromyalgia Symptom Severity
Symptoms will be assessed using the Revised Fibromyalgia Impact Questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity and a greater impact of fibromyalgia on daily functioning and quality of life.
Respiratory Muscle Strength
Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested
Locations
Sponsors and contacts
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