Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Six-Minute Walk Test Distance
研究概览
简要总结
This study aims to investigate the effects of Clinical Pilates on physical and psychosocial outcomes in individuals with interstitial lung disease (ILD). Interstitial lung disease is a group of chronic conditions that affect lung tissue and can lead to breathing difficulties, reduced physical capacity, fatigue, and decreased quality of life.
In addition to medical treatment, exercise-based rehabilitation approaches may help individuals with ILD improve their physical function and overall well-being. Clinical Pilates is a structured exercise method that focuses on breathing control, posture, core stability, flexibility, and body awareness.
Participants in this study will be randomly assigned to either a Clinical Pilates group or a control group receiving standard care. The Clinical Pilates program will be delivered by a trained physiotherapist over several weeks through supervised sessions.
The main outcomes of this study include physical function, respiratory symptoms, quality of life, and psychological well-being. The results of this study are expected to provide evidence on whether Clinical Pilates can be an effective and safe supportive approach for pulmonary rehabilitation in individuals with interstitial lung disease.
详细描述
This study is designed to evaluate the effectiveness of Clinical Pilates as a supportive rehabilitation approach for individuals with interstitial lung disease (ILD). ILD is a group of chronic and progressive lung disorders characterized by impaired gas exchange, reduced lung compliance, and exercise intolerance. Individuals with ILD commonly experience dyspnea, fatigue, decreased physical capacity, and psychosocial difficulties, which negatively affect daily functioning and quality of life.
Although pharmacological treatment is essential for disease management, pulmonary rehabilitation has been increasingly recognized as an important component of comprehensive care in ILD. Exercise-based interventions may improve functional capacity, symptom perception, and psychological well-being. However, evidence regarding specific structured exercise methods such as Clinical Pilates in individuals with ILD remains limited.
Clinical Pilates is a physiotherapist-guided exercise approach that emphasizes controlled breathing, postural alignment, core stability, flexibility, and body awareness. The method aims to enhance movement efficiency, improve respiratory control, and support both physical and mental well-being. Due to its low-impact and adaptable nature, Clinical Pilates may be particularly suitable for individuals with chronic respiratory conditions.
In this randomized controlled study, eligible participants will be randomly assigned to either a Clinical Pilates intervention group or a control group receiving standard care. The intervention will consist of supervised Clinical Pilates sessions delivered by a trained physiotherapist over a predefined period. The exercises will be individually adapted according to participants' functional capacity and clinical status.
The primary outcomes of the study include physical function and respiratory symptoms. Secondary outcomes include quality of life, psychological well-being, and psychosocial functioning. Outcome measures will be assessed at baseline and after completion of the intervention period.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Clinically confirmed diagnosis of interstitial lung disease (ILD) by a physician.
- •Clinically stable condition (no acute exacerbation or hospitalization related to ILD within the last 4 weeks).
- •On stable medical treatment and routine follow-up.
- •Able to walk and participate in low-to-moderate intensity exercise as determined by the clinician/physiotherapist.
- •Able to understand study procedures and provide written informed consent.
排除标准
- •Coexisting chronic respiratory disease that may confound outcomes (e.g., COPD, uncontrolled asthma, bronchiectasis).
- •Acute exacerbation of ILD or hospitalization within the last 4 weeks.
- •Unstable cardiovascular disease or other medical conditions making exercise unsafe (e.g., unstable angina, recent myocardial infarction).
- •Severe neurological, musculoskeletal, or balance disorders limiting safe participation in exercise.
- •Pulmonary hypertension or oxygen dependency requiring unstable/high-flow support if judged unsafe for exercise participation by the treating clinician.
- •Current participation in another structured exercise / pulmonary rehabilitation program during the study period.
- •Major psychiatric disorder or cognitive impairment interfering with participation or adherence.
- •Pregnancy.
研究组 & 干预措施
Clinical Pilates Group
Participants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement.
干预措施: Clinical Pilates (Behavioral)
Clinical Pilates Group
Participants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement.
干预措施: standart care (Other)
Standard Care Control Group
Participants will receive standard medical care for interstitial lung disease without additional structured exercise or Clinical Pilates intervention.
干预措施: standart care (Other)
结局指标
主要结局
Six-Minute Walk Test Distance
时间窗: Baseline (Week 0) and Week 8
Physical function will be assessed using the Six-Minute Walk Test (6MWT). Total walking distance will be recorded.
Modified Medical Research Council Dyspnea Scale Score
时间窗: Baseline (Week 0) and Week 8
Respiratory symptom severity will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale total score. Points (range 0-4; higher scores indicate worse dyspnea)
次要结局
未报告次要终点
研究者
Seda Karaca
Dr
Recep Tayyip Erdogan University