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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | 30 women with fibromyalgia who will receive manual diaphragmatic release sessions followed by a structured aerobic training program on a cycle ergometer for 8 weeks |
|
| Control group | Active Comparator | 30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Diaphragmatic Release | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Capacity | Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing | Baseline and after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saher Lotfy Elgayar, Ph.D | Contact | +201020429911 | saherlotfy020@gmail.com | |
| Mohammed Youssef Elhamrawy, Ph.D | Contact |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Aerobic Training | Other | 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. |
|
| 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. |
| Baseline and after 8 weeks |
| Respiratory Muscle Strength | Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested | Baseline and after 8 weeks |
| D009422 |
| Nervous System Diseases |