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

ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorMiddle East University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Diaphragmatic Release

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Study groupActive comparator 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Capacity

Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing

Time frame
Baseline and after 8 weeks

Secondary outcomes

1

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
2

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
3

Respiratory Muscle Strength

Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested

Time frame
Baseline and after 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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