An interventional study of Manual Diaphragmatic Release and Aerobic Training in Fibromyalgia, sponsored by Middle East University. Not yet recruiting. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Middle East University · Not applicable, Interventional, and Treatment
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Middle East University is the lead sponsor of 19 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Manual Diaphragmatic Release · Other: Aerobic Training
30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks.
Other: Aerobic Training
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.
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.
Exercise Capacity
Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing
Time frame: Baseline and after 8 weeks
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.
Time frame: Baseline and after 8 weeks
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.
Time frame: Baseline and after 8 weeks
Respiratory Muscle Strength
Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested
Time frame: Baseline and after 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Middle East University