The Effects of Inspiratory Muscle Training on the Autonomic Nervous System and Clinical Symptoms in Female Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Autonomic nervous system- HRV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Autonomic nervous system- HRV
时间窗: 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.
The procedure will be performed using a 24-hour ECG Holter monitor.
Autonomic Nervous System- COMPASS-31
时间窗: 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.
The Composite Autonomic Symptom Score-31 questionnaire will be used.
次要结局
- 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.)
- Maximal inspiratory pressure(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.)
研究者
Gürkan Demirtas
PhD
Nigde Omer Halisdemir University