Physiotherapy-Integrated Yoga and Mindfulness Plus Home Exercise Versus Home Exercise Alone for Individuals With Fibromyalgia (PhYoMind): A Single-Blind, Parallel-Group, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disability, Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The current study investigates the effect of an integrative physiotherapy and mind-body program called PhYoMind intervention on disability and symptoms in individuals with fibromyalgia (FM). Participants will be randomized to either the PhYoMind intervention, which combines specific physiotherapy techniques with yoga and mindfulness, or to a home exercise control group. The intervention lasts 8 weeks, with supervised and home sessions. The primary outcome is disability, with secondary outcomes including measures of central and autonomic nervous system function, pain perception, stress, fatigue, and sleep quality. Adverse events and adherence of the intervention will be also assessed.
详细描述
FM is a chronic disorder characterized by widespread pain, fatigue, sleep disturbances, and autonomic/central nervous system dysfunction. Despite its high prevalence, treatment options remain limited and often focus on symptom management rather than addressing underlying dysregulation. Emerging evidence also implicates abnormalities in the central nervous system (CNS) and autonomic nervous system (ANS) in the development and persistence of FM symptoms.
Although physiotherapy and mind-body interventions including yoga and mindfulness have individually shown benefits for fibromyalgia symptoms, there is a lack of research on combined interventions integrating these therapies.
The present randomized controlled trial investigates the effects of PhYoMind, a novel integrative and complementary program combining physiotherapy techniques in particular, Proprioceptive Neuromuscular Facilitation (PNF), Nerve Gliding Exercises (NGE), Mobility Exercises (ME), and Post-Isometric Relaxation (PIR), with yoga and mindfulness practices. The intervention aims to improve disability and address multiple symptoms in people with FM through this integrated program.
Participants will be randomly assigned to receive either the PhYoMind program or a home exercises including stretching, strengthening, and aerobic exercises over 8 weeks. Two supervised sessions per week will be complemented by prescribed home exercises. Outcomes will be assessed at baseline (Week 0) and immediately after post-intervention (Week 8), including disability (primary outcome), as well as pain perception, stress, fatigue, sleep quality, central/autonomic nervous system function. In addition, adverse events and adherence of the intervention will be assessed.
This study will contribute valuable evidence regarding the potential benefits of an integrated physiotherapy and mind-body interventions in managing fibromyalgia symptoms.
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
- Single (Outcomes Assessor)
盲法说明
Data analysis will also be conducted blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology
排除标准
- •Other serious illnesses causing severe pain and complicating participation in the study
- •Receiving another physiotherapy treatment concurrently with this study
- •Regular practice of yoga and/or mindfulness exercises prior to the study
- •History of acute myocardial infarction or heart failure and resulting cardiac capacity limitations.
- •Uncontrolled hypertension (resting systolic/diastolic blood pressure ≥160/100 mmHg)
- •Current treatment with medications known to significantly affect HRV (e.g. beta-blockers or antiarrhythmic drugs)
- •Pregnancy or planned pregnancy during the study period
- •Severe psychiatric disorders or insufficient cognitive abilities resulting in inability to participate in the study
- •Participants must either be on a stable treatment for FMS or not receiving any treatment, with no intention to alter their treatment plan during the study period. (Any unintended changes in fibromyalgia-related medications or other treatments during the study will be recorded and documented).
研究组 & 干预措施
Home Exercise Group
Only Home Exercise (walking + strenghtening + streching)
干预措施: Exercise (Other)
PhYoMind Intervention Group
Physiotherapy techniques integrated with yoga and mindfulness + Home Exercise
干预措施: PhYoMind (Other)
结局指标
主要结局
Disability, Fibromyalgia Impact Questionnaire (FIQ)
时间窗: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
The FIQ is a valid and reliable questionnaire with a total score range of 0-100 measuring overall disease severity, pain severity, physical functioning, work difficulties, morning fatigue, depression, anxiety, and general well-being rated by individuals with fibromyalgia. Higher scores indicate a greater impact of symptoms.
次要结局
- Central Nervous System Assessment, Central Sensitization Inventory (CSI)(At baseline (Week 0) and after 8 weeks of intervention (Week 8))
- Autonomic Nervous System Assessment, Heart Rate Variability (HRV)(At baseline (Week 0) and after 8 weeks of intervention (Week 8))
- Sleep Assessment, Pittsburgh Sleep Quality Index (PSQI)(At baseline (Week 0) and after 8 weeks of intervention (Week 8))
- Stress Assessment, Perceived Stress Scale (PSS)(At baseline (Week 0) and after 8 weeks of intervention (Week 8))
- Pain Perception, The Visual Analog Scale (VAS)(At baseline (Week 0) and after 8 weeks of intervention (Week 8))
- Fatique Assessment, The 20-item Multidimensional Fatigue Index (MFI)(At Baseline (Week 0) and after 8 weeks of intervention (Week 8))