The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia

Sponsor
Nigde Omer Halisdemir University
Study ID
NCT07261696
Status
Not Yet Recruiting

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Conditions

  • Autonomic Dysfunction
  • Fibromyalgia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 3, 2025
Start date
Dec 5, 2025
Status verified
Oct 2025
Primary completion
Dec 5, 2026
Completion
Dec 5, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week
  • Sham Comparator: Sham group
    Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week
  • No Intervention: Control group
    No Intervention

Primary Outcome Measure

Autonomic nervous system- HRV [ Time Frame: 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. ]

Central Contacts

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