FibromyalgiaNCT07641166
Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia
A study testing Manual Diaphragmatic Release and Aerobic Training in people with Fibromyalgia, run by Middle East University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Manual Diaphragmatic Release and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2026to 8 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Youssef Elhamrawy, Ph.D contact
About this study
Official title: Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Manual Diaphragmatic Release, Aerobic Training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Manual Diaphragmatic Release; Other: Aerobic Training |
| Control group | Active comparator | 30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks. Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing
Measured: Baseline and after 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: Baseline and after 8 weeks
Respiratory Muscle Strength
Maximal Inspiratory Pressure and Maximal Expiratory Pressure will be tested
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start17 Jun 2026 (estimated)
- Primary completion3 Nov 2026 (estimated)
- Study completion8 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641166
- Sponsor's protocol ID
- Diaphragmatic Release
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07641166
- Acronym / sponsor ID
- Diaphragmatic Release
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 17 Jun 2026 (estimated)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 8 Nov 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: 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 group | Active comparator | Other: Aerobic Training30 women with fibromyalgia who will participate in the standardized aerobic training program alone for 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Diaphragmatic ReleaseThrice 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. | Other | Study group |
| Aerobic Training3 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. | Other | Control group, Study group |
Primary outcome
Exercise Capacity
Time frame: Baseline and after 8 weeks
Maximal Oxygen Consumption via Cardiopulmonary Exercise Testing
3 secondary outcomes
Health-Related Quality of Life
Time frame: Baseline and after 8 weeks
Fibromyalgia Symptom Severity
Time frame: Baseline and after 8 weeks
Respiratory Muscle Strength
Time frame: Baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Youssef Elhamrawy, Ph.D contact
Questions about this trial
What is this clinical trial studying?
A study testing Manual Diaphragmatic Release and Aerobic Training in people with Fibromyalgia, run by Middle East University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Lotfy Elgayar, Ph.D (+201020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.