FibromyalgiaNCT07261696
The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia
A study testing Exercise in people with Fibromyalgia and Autonomic Dysfunction, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Autonomic Dysfunction
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 5 Dec 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged between 18 and 65 years old,
- Have been diagnosed with fibromyalgia according to the 2010/2016 ACR criteria,
- Be female,
- Have moderate pain lasting at least 3 months and defined as at least 30 mm on the 0-100 mm visual analogue scale (VAS).
Who cannot join
- Presence of chronic heart disease,
- Current use of narcotic drugs,
- History of asthma or other chronic respiratory diseases,
- Pregnancy,
- Diabetes, kidney, adrenal, pituitary or thyroid disorders,
- History of serious neurological or psychiatric disorders (e.g. mania, psychosis, suicidal tendencies, bipolar disorder, schizophrenia, autism spectrum disorders),
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- Neurodegenerative diseases (e.g. Parkinson's, Alzheimer's, Huntington's disease),
- Head trauma, migraine,
- Presence of active cardiac implants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir Üniversitesi
Niğde, Niğde Province, 51200
Gürkan Demirtaş, PhD, +90 388 311 2105, gurkandemirtas@ohu.edu.tr
About this study
Official title: The Effects of Inspiratory Muscle Training on the Autonomic Nervous System and Clinical Symptoms in Female Patients With Fibromyalgia
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Although exercise is recommended in treatment, low motivation and fatigue often limit participation. Therefore, inspiratory muscle training (IMT), which targets the respiratory muscles, is seen as an easy-to-apply alternative.This randomized, controlled, double-blind study will be conducted at Niğde Ömer Halisdemir University Hospital. Fifty-one women aged 18-65 years who meet the 2010/2016 ACR criteria for fibromyalgia will be randomly assigned to three groups: training (30% of maximal inspiratory pressure), sham (0-10%), and control (no training). ANS functions will be assessed using heart rate variability and the COMPASS-31 questionnaire. Pain, sleep quality, fatigue, anxiety, depression, and respiratory muscle strength will also be evaluated. Training will be performed with the Powerbreathe® device twice daily for six weeks.The study aims to investigate the effects of IMT on ANS functions in fibromyalgia and to explore its relationship with symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression.
Read the detailed description
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms, the exact cause of which remains unclear. Autonomic nervous system (ANS) dysfunction, characterized by increased sympathetic activity and decreased parasympathetic tone, is considered one of the major pathophysiological mechanisms of the disease. Exercise is a strongly recommended non-pharmacological approach in the treatment of fibromyalgia; however, low motivation, fatigue, and poor adherence often limit the applicability of conventional aerobic or resistance exercise programs. Therefore, inspiratory muscle training (IMT), which specifically targets the respiratory muscles, is considered an alternative method that is easy to apply and may have regulatory effects on ANS function.
This randomized, controlled, double-blind, and prospective study will be conducted in the Rheumatology and Cardiology Clinics of Niğde Ömer Halisdemir University Training and Research Hospital. A total of 51 female participants aged 18-65 years who meet the 2010/2016 American College of Rheumatology (ACR) criteria for fibromyalgia will be randomly assigned to three groups: the training group (30% maximal inspiratory pressure [MIP]), the sham group (0-10% MIP), and the control group (no training). ANS functions will be evaluated by heart rate variability (HRV) and the COMPASS-31 questionnaire. Pain will be assessed using the Visual Analog Scale and pressure pain threshold; sleep quality by the Pittsburgh Sleep Quality Index; fatigue by the Modified Fatigue Impact Scale; anxiety and depression by the Hospital Anxiety and Depression Scale; and respiratory muscle strength by the Powerbreathe® K5 device. Training will be performed using the Powerbreathe® Classic device twice daily, seven days per week, for six weeks.
The primary aim of this study is to evaluate the effects of inspiratory muscle training on autonomic nervous system functions in patients with fibromyalgia. Secondarily, the effects of this training on symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression, as well as the relationship between these symptoms and changes in ANS activity, will be investigated.
- Conditions
- Fibromyalgia, Autonomic Dysfunction
- Being tested
- Exercise
- Medical subject headings
- Fibromyalgia, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Inspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week Receives: Other: Exercise |
| Sham group | Sham comparator | Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week Receives: Other: Exercise |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic nervous system- HRV
The procedure will be performed using a 24-hour ECG Holter monitor.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Autonomic Nervous System- COMPASS-31
The Composite Autonomic Symptom Score-31 questionnaire will be used.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Secondary outcomes (6)
Pain- Visual Analogue Scale
Visual Analogue Scale will be used.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Pain- Pressure Pain Treshold
The pain threshold will be assessed using a standard pressure algometer
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Sleep- Pittsburgh sleep quality index
Pittsburgh sleep quality index questionnaire will be used.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Fatigue- Modified Fatigue Impact Scale
Modified Fatigue Impact Scale will be used.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Anxiety and Depression- Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire will be used.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Maximal inspiratory pressure
Measurements will be taken using the PowerBreathe K5 MIP device to determine the exercise load.
Measured: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start5 Dec 2025 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gürkan Demirtas, Nigde Omer Halisdemir University
- Investigators
- Gürkan Demirtaş, PhD, Principal investigator, Niğde Ömer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261696
- Sponsor's protocol ID
- E-95860085-050.04-722238
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on the Autonomic Nervous System and Clinical Symptoms in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07261696
- Acronym / sponsor ID
- E-95860085-050.04-722238
- Conditions
- Fibromyalgia, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Although exercise is recommended in treatment, low motivation and fatigue often limit participation. Therefore, inspiratory muscle training (IMT), which targets the respiratory muscles, is seen as an easy-to-apply alternative.This randomized, controlled, double-blind study will be conducted at Niğde Ömer Halisdemir University Hospital. Fifty-one women aged 18-65 years who meet the 2010/2016 ACR criteria for fibromyalgia will be randomly assigned to three groups: training (30% of maximal inspiratory pressure), sham (0-10%), and control (no training). ANS functions will be assessed using heart rate variability and the COMPASS-31 questionnaire. Pain, sleep quality, fatigue, anxiety, depression, and respiratory muscle strength will also be evaluated. Training will be performed with the Powerbreathe® device twice daily for six weeks.The study aims to investigate the effects of IMT on ANS functions in fibromyalgia and to explore its relationship with symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression.
Detailed description
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms, the exact cause of which remains unclear. Autonomic nervous system (ANS) dysfunction, characterized by increased sympathetic activity and decreased parasympathetic tone, is considered one of the major pathophysiological mechanisms of the disease. Exercise is a strongly recommended non-pharmacological approach in the treatment of fibromyalgia; however, low motivation, fatigue, and poor adherence often limit the applicability of conventional aerobic or resistance exercise programs. Therefore, inspiratory muscle training (IMT), which specifically targets the respiratory muscles, is considered an alternative method that is easy to apply and may have regulatory effects on ANS function.
This randomized, controlled, double-blind, and prospective study will be conducted in the Rheumatology and Cardiology Clinics of Niğde Ömer Halisdemir University Training and Research Hospital. A total of 51 female participants aged 18-65 years who meet the 2010/2016 American College of Rheumatology (ACR) criteria for fibromyalgia will be randomly assigned to three groups: the training group (30% maximal inspiratory pressure [MIP]), the sham group (0-10% MIP), and the control group (no training). ANS functions will be evaluated by heart rate variability (HRV) and the COMPASS-31 questionnaire. Pain will be assessed using the Visual Analog Scale and pressure pain threshold; sleep quality by the Pittsburgh Sleep Quality Index; fatigue by the Modified Fatigue Impact Scale; anxiety and depression by the Hospital Anxiety and Depression Scale; and respiratory muscle strength by the Powerbreathe® K5 device. Training will be performed using the Powerbreathe® Classic device twice daily, seven days per week, for six weeks.
The primary aim of this study is to evaluate the effects of inspiratory muscle training on autonomic nervous system functions in patients with fibromyalgia. Secondarily, the effects of this training on symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression, as well as the relationship between these symptoms and changes in ANS activity, will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: ExerciseTraining at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week |
| Sham group | Sham comparator | Other: ExerciseTraining at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged between 18 and 65 years old,
- Have been diagnosed with fibromyalgia according to the 2010/2016 ACR criteria,
- Be female,
- Have moderate pain lasting at least 3 months and defined as at least 30 mm on the 0-100 mm visual analogue scale (VAS).
Key exclusion criteria (9 listed)
- Presence of chronic heart disease,
- Current use of narcotic drugs,
- History of asthma or other chronic respiratory diseases,
- Pregnancy,
- Diabetes, kidney, adrenal, pituitary or thyroid disorders,
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 |
|---|---|---|
| ExerciseInspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks. | Other | Sham group, Study Group |
Primary outcome
Autonomic nervous system- HRV
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
The procedure will be performed using a 24-hour ECG Holter monitor.
Autonomic Nervous System- COMPASS-31
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
The Composite Autonomic Symptom Score-31 questionnaire will be used.
6 secondary outcomes
Pain- Visual Analogue Scale
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Pain- Pressure Pain Treshold
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Sleep- Pittsburgh sleep quality index
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Fatigue- Modified Fatigue Impact Scale
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Anxiety and Depression- Hospital Anxiety and Depression Scale
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
Maximal inspiratory pressure
Time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.
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 3 Dec 2025.
- 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.
Gürkan Demirtaş, PhD principal investigator
Niğde Ömer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia and Autonomic Dysfunction, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 9 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Gürkan Demirtaş, PhD (+90 388 311 2105, gurkandemirtas@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic nervous system- HRV (time frame: At the time participants joined the study and after the 6-week training for the intervention and sham groups, and 6 weeks later for the control group.). The study lists 2 primary outcomes in all. 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 3 Dec 2025.