Fibromyalgia (FM)NCT06647147
Aerobic Training on Lung Function in Fibromyalgia
A study testing Aerobic training and Diaphragmatic breathing exercises in people with Fibromyalgia (FM) and Respiration Disorders, run by Middle East University.
Trial summary
Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Fibromyalgia (FM), Respiration Disorders
- What is being tested?
- Aerobic training and Diaphragmatic breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2024to 15 May 2025
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Well controlled fibromyalgia.
- Mild restrictive lung affection.
- Body mass index less than 30kg/m2.
- Moderate level of physical activity.
Who cannot join
- Any chest diseases.
- Musculoskeletal/ neurological limitations to exercise.
- Smokers.
- Pregnant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Aerobic Training on Lung Function in Women With Fibromyalgia
Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.
Read the detailed description
Eighty women with fibromyalgia will be equally randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. The Ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the CON will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. The lung functions will be assessed by the spirometry testing. The chest expansion will be determined using a tape measurement. Additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. All the outcomes will be examined at baseline, and after 12 weeks of the intervention.
- Conditions
- Fibromyalgia (FM), Respiration Disorders
- Being tested
- Aerobic training, Diaphragmatic breathing exercises
- Medical subject headings
- Fibromyalgia, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
For twelve weeks, the women in the study group will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down.
Diaphragmatic breathing exercisesOther
From the hook-lying position, the women will receive instructions to position their hands on the rectus abdominis muscle located under the anterior chest wall. They will be advised to inhale slowly and deeply, expanding their abdomen without causing any movement in their upper chest, while simultaneously relaxing their shoulders. Slowly, the women will expel every breath. Air will be inhaled via the nose, swelling the abdomen. After the breath ceased, the women will purse her lips and exhale from his mouth with half-opened lips and a hollow belly. A single respiratory cycle consists of a three-second intake, followed by a three-second pause, and concluding with a six-second expiration phase.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | 40 women with fibromyalgia will participate in low to moderate intensity aerobic training plus diaphragmatic breathing exercises. Receives: Other: Aerobic training; Other: Diaphragmatic breathing exercises |
| Control group | Active comparator | 40 women with fibromyalgia will only participate in diaphragmatic breathing exercises. Receives: Other: Diaphragmatic breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second will be measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.
Measured: At baseline and 12 weeks
Secondary outcomes (2)
Chest expansion
A centimeter tape measure will be used to assess chest expansion, and all measurements will be taken with the patients adopting a straight posture while standing. Two levels of chest expansion will be measured, the axillary level will be evaluated for upper chest expansion assessment, and the xyphoid level will be evaluated for lower chest expansion assessment.
Measured: At baseline and 12 weeks
Exercise capacity
Cardiopulmonary exercise test will be conducted for all women at baseline and post-study based on the guidelines set by the American College of Sports Medicine to determine VO2max for each women.
Measured: At baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start25 Nov 2024 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Kasr El Aini Hospital
- Investigators
- Mohammed Sayed Saif, Ph.D, Study director, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647147
- Sponsor's protocol ID
- Aerobic Training
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Training on Lung Function in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06647147
- Acronym / sponsor ID
- Aerobic Training
- Conditions
- Fibromyalgia (FM), Respiration Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.
Detailed description
Eighty women with fibromyalgia will be equally randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. The Ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the CON will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. The lung functions will be assessed by the spirometry testing. The chest expansion will be determined using a tape measurement. Additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. All the outcomes will be examined at baseline, and after 12 weeks of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Aerobic training, Other: Diaphragmatic breathing exercises40 women with fibromyalgia will participate in low to moderate intensity aerobic training plus diaphragmatic breathing exercises. |
| Control group | Active comparator | Other: Diaphragmatic breathing exercises40 women with fibromyalgia will only participate in diaphragmatic breathing exercises. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Well controlled fibromyalgia.
- Mild restrictive lung affection.
- Body mass index less than 30kg/m2.
- Moderate level of physical activity.
Key exclusion criteria (4 listed)
- Any chest diseases.
- Musculoskeletal/ neurological limitations to exercise.
- Smokers.
- Pregnant.
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 |
|---|---|---|
| Aerobic trainingFor twelve weeks, the women in the study group will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down. | Other | Study group |
| Diaphragmatic breathing exercisesFrom the hook-lying position, the women will receive instructions to position their hands on the rectus abdominis muscle located under the anterior chest wall. They will be advised to inhale slowly and deeply, expanding their abdomen without causing any movement in their upper chest, while simultaneously relaxing their shoulders. Slowly, the women will expel every breath. Air will be inhaled via the nose, swelling the abdomen. After the breath ceased, the women will purse her lips and exhale from his mouth with half-opened lips and a hollow belly. A single respiratory cycle consists of a three-second intake, followed by a three-second pause, and concluding with a six-second expiration phase. | Other | Control group, Study group |
Primary outcome
Lung function
Time frame: At baseline and 12 weeks
Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second will be measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.
2 secondary outcomes
Chest expansion
Time frame: At baseline and 12 weeks
Exercise capacity
Time frame: At baseline and 12 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 17 Oct 2024.
- 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 Sayed Saif, Ph.D study director
National institute for Gerontology
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Diaphragmatic breathing exercises in people with Fibromyalgia (FM) and Respiration Disorders, 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 4 inclusion and 4 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 17 Oct 2024. 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?
Lung function (time frame: At baseline and 12 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 17 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.