Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia

NCT07641166 — Not applicable, Not yet recruiting, 60 participants, Middle East University

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Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled Trial

RegistryNCT07641166
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment60 (Estimated)
SponsorMiddle East University (Other)
ConditionsFibromyalgia
InterventionsManual Diaphragmatic Release, Aerobic Training (Other)
Datesstart 2026-06-17 (estimated), primary completion 2026-11-03 (estimated), completion 2026-11-08 (estimated), first posted 2026-06-11, last updated 2026-06-11

Related Papers Related Patents Related Grants Related Experts
All trials for Fibromyalgia All trials of Manual Diaphragmatic Release All trials of Aerobic Training

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Study groupActive comparatorOther: Manual Diaphragmatic Release; Other: Aerobic Training30 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 groupActive comparatorOther: Aerobic Training30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks.
  • 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.
  • 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.

+Outcome measures

Primary outcomes

  • Exercise Capacity [Baseline and after 8 weeks]: Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing

Secondary outcomes

  • 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

+Eligibility

Sex: Female, ages: 18 Years to 55 Years

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.