Not yet taking people in TürkiyeNo phase

The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

Key facts

Who runs it: Nigde Omer Halisdemir University
Where: Niğde, TürkiyeSee the site
Trial code: NCT07261696
Status: Not yet recruiting
People taking part: 51 people, planned
Started: 5 Dec 2025
Expected to end: 5 Dec 2026
Type of study: Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested: Exercise
Record updated: 3 December 2025

Who can take part

Age: 18 years to 65 years
Sex: Women only
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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 take part

Current use of narcotic drugs,
Presence of chronic heart disease,
History of asthma or other chronic respiratory diseases,
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),
Neurodegenerative diseases (e.g. Parkinson's, Alzheimer's, Huntington's disease),
Presence of active cardiac implants
Pregnancy,
Head trauma, migraine,

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in Türkiye

Niğde Ömer Halisdemir ÜniversitesiNiğde, TürkiyeContact: Gürkan Demirtaş, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Study GroupTreatment being tested
Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week
Treatment: Exercise
Sham groupSham treatment, for comparison
Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week
Treatment: Exercise
Control groupNo study treatment, for comparison
No Intervention