The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

NCT ID: NCT07261696

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2026-12-05

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study Group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Sham group

Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week

Group Type: SHAM_COMPARATOR

Exercise

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Gürkan Demirtas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gürkan Demirtaş, PhD

Role: PRINCIPAL_INVESTIGATOR

Niğde Ömer Halisdemir University

Locations

Niğde Ömer Halisdemir Üniversitesi

Niğde, Niğde Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Gürkan Demirtaş, PhD

Role: CONTACT

gurkandemirtas@ohu.edu.tr

+90 388 311 2105

Facility Contacts

Gürkan Demirtaş, PhD

Role: primary

gurkandemirtas@ohu.edu.tr

+90 388 311 2105

Other Identifiers

E-95860085-050.04-722238

Identifier Type: -

Identifier Source: org_study_id