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Clinical Trials in Turkey / NCT07261696
Starting soon Not applicable

The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

NCT07261696 · tracked via the Priya Life Science Turkey tracker
Sponsor
Nigde Omer Halisdemir University
Phase
Not applicable
Started
2025-12-05
Last updated
2025-12-03

Condition(s) studied

FibromyalgiaAutonomic Dysfunction

Investigational drug(s) / intervention(s)

Exercise

Exercise: Inspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks.

Study 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. 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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), * Neurodegenerative diseases (e.g. Parkinson's, Alzheimer's, Huntington's disease), * Head trauma, migraine, * Presence of active cardiac implants.

Primary outcome measure(s)

  • Autonomic nervous system- HRV — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Niğde Ömer Halisdemir Üniversitesi Niğde Niğde Province

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261696 on ClinicalTrials.gov ↗ ← All trials in Turkey