The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNigde Omer Halisdemir University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Presence of chronic heart disease,
Current use of narcotic drugs,
History of asthma or other chronic respiratory diseases,
Pregnancy,
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionInspiratory muscle training program will be applied to the study and sham group for 7 days/6 weeks.
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Study GroupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Autonomic nervous system- HRV
The procedure will be performed using a 24-hour ECG Holter monitor.
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.2
Autonomic Nervous System- COMPASS-31
The Composite Autonomic Symptom Score-31 questionnaire will be used.
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.Secondary outcomes
1
Pain- Visual Analogue Scale
Visual Analogue Scale will be used.
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.2
Pain- Pressure Pain Treshold
The pain threshold will be assessed using a standard pressure algometer
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.3
Sleep- Pittsburgh sleep quality index
Pittsburgh sleep quality index questionnaire will be used.
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.4
Fatigue- Modified Fatigue Impact Scale
Modified Fatigue Impact Scale will be used.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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