NCT07641166

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 17, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2026

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 3, 2026

Last Update Submit

June 8, 2026

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing

    Baseline and after 8 weeks

Secondary Outcomes (3)

  • Health-Related Quality of Life

    Baseline and after 8 weeks

  • Fibromyalgia Symptom Severity

    Baseline and after 8 weeks

  • Respiratory Muscle Strength

    Baseline and after 8 weeks

Study Arms (2)

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

Other: Manual Diaphragmatic ReleaseOther: Aerobic Training

Control group

ACTIVE COMPARATOR

30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks.

Other: Aerobic Training

Interventions

Aerobic TrainingOTHER

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.

Control groupStudy group
Manual Diaphragmatic ReleaseOTHER

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.

Study group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Saher Lotfy Elgayar, Ph.D

CONTACT

+201020429911saherlotfy020@gmail.com

Mohammed Youssef Elhamrawy, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 11, 2026

Study Start (Estimated)

June 17, 2026

Primary Completion (Estimated)

November 3, 2026

Study Completion (Estimated)

November 8, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share