Fibromyalgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERManual Diaphragmatic Release
Thrice 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.
OTHERAerobic Training
3 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.
Sponsors
Middle East University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | Baseline and after 8 weeks | Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | Baseline and after 8 weeks | 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 | Baseline and after 8 weeks | 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 | Baseline and after 8 weeks | Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested |
Contacts
CONTACTSaher Lotfy Elgayar, Ph.D
CONTACTMohammed Youssef Elhamrawy, Ph.D
Outcome results
None listed