The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia; Autonomic Dysfunction
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gürkan Demirtaş, PhD; Phone Number: +90 388 311 2105; Email: gurkandemirtas@ohu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Niğde Province
    • Niğde, Niğde Province, Turkey (Türkiye), 51200
      • Niğde Ömer Halisdemir Üniversitesi
      • Contact: Gürkan Demirtaş, PhD; Phone Number: +90 388 311 2105; Email: gurkandemirtas@ohu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No Intervention
Experimental: Study Group; Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week	Other: Exercise; Inspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks.
Sham Comparator: Sham group; Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week	Other: Exercise; Inspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain- Visual Analogue Scale	Visual Analogue Scale 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.
Pain- Pressure Pain Treshold	The pain threshold will be assessed using a standard pressure algometer	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.	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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: Nigde Omer Halisdemir University
• Investigators: Principal Investigator: Gürkan Demirtaş, PhD, Nigde Omer Halisdemir University

Study record dates

Study Major Dates

• Study Start (Estimated): December 5, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Autonomic Nervous System Diseases; Fibromyalgia; Primary Dysautonomias; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: E-95860085-050.04-722238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No