Efficacy of Pulmonary Rehabilitation Augmented by Yoga on Exercise Capacity and Quality of Life in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
研究概览
简要总结
The trial is a single center open label randomized parallel group three arm non inferiority study being conducted at AIIMS New Delhi. 116 eligible COPD patients are enrolled and randomised by sex into one of three intervention arms yoga alone,pulmonary rehabilitation alone or combined yoga plus PR, each for 12 weeks. The interventions include in-person, supervised hospital sessions, followed by telesupervised home sessions using wearable devices to monitor adherence and activity.
Primary and Secondary Outcomes
Primary outcome is improvement in exercise capacity measured by the 6 minute walk test at 12 weeks. Secondary outcomes include maximal exercise capacity, VO2 max, COPD Assessment Test, lung function FEV1, forced oscillometry parameters, body plethysmography, time to next exacerbation, body composition, inflammatory biomarkers CRP, SAA, IL6, IL10, YKL40, 8Isoprostane, FENO and feasibility of telemonitored parameters.
Methodology and Analysis
Inclusion criteria are Moderate to severe COPD with controlled symptoms, willingness for in hospital and home based intervention, written consent. Exclusion criteria are Active respiratory infections, major comorbidities, inability to perform trial activities, before yoga rehab participation or concurrent trial participation
Data analysis is planned via Intention to treat and per protocol approaches with analysis of covariance ANCOVA and adjustments for baseline values and confounders dropouts expected at 20 with results interpreted under CONSORT and noninferiority reporting guidelines
Rationale and Expected Impact
The study seeks to clarify the clinical effectiveness of combining yoga and PR versus single modalities aiming for improvements in functional capacity inflammation and wellbeing for COPD patients in a cost effective accessible hybrid format. Outcomes are expected to inform best practices for integrative nonpharmacological management in pulmonary rehabilitation settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate to severe COPD (FEV1 less than 50% predicted) Controlled symptoms for the last 7 days, without systemic steroids or antibiotics Willing to participate and attend in-hospital pulmonary rehabilitation for the next 12 weeks Ready to give written informed consent.
排除标准
- •Patients requiring hospitalisation (till stabilization/recovery) (shall be reassessed for inclusion after discharge) On treatment for active respiratory infections (e.g., tuberculosis, chronic pulmonary aspergillosis etc.) Presence of severe comorbidities such as hematological or solid organ malignancy, symptomatic cardiovascular disease, musculoskeletal or neurological disease that might affect ambulation or exercise training Ccognitive dysfunction, mental disorder or abnormal behaviors Inability to follow up as per protocol Participation in a pulmonary rehabilitation programme in the past 12 months Currently practicing yoga based rehabilitation Participating in another interventional trial Patients with a life expectancy of less than four weeks.
研究者
Pawan Tiwari
All India Institute of Medical Sciences, New Delhi