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NCT Number: NCT07641166

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

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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Exercise Capacity

    Time frame: Baseline and after 8 weeks

    Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing

Secondary outcomes

  1. Health-Related Quality of Life

    Time frame: 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.

  2. Fibromyalgia Symptom Severity

    Time frame: 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.

  3. Respiratory Muscle Strength

    Time frame: Baseline and after 8 weeks

    Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Youssef Elhamrawy, Ph.D

CONTACT

Saher Lotfy Elgayar, Ph.D

CONTACT

[email protected]

+201020429911

Sponsors and collaborators

Lead sponsor

Middle East University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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