The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

NCT07261696 | Not Yet Recruiting

• 1 other identifier: E-95860085-050.04-722238
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (2)

• Autonomic nervous system- HRV

  The procedure will be performed using a 24-hour ECG Holter monitor.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (3)

Study Group

EXPERIMENTAL

Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week

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

Other: Exercise

Control group

NO INTERVENTION

No Intervention

Interventions

Exercise OTHER

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

Sham group; Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir Üniversitesi

Niğde, Niğde Province, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gürkan Demirtaş, PhD

  Niğde Ömer Halisdemir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gürkan Demirtaş, PhD

CONTACT

+90 388 311 2105; gurkandemirtas@ohu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)