Yoga in Pulmonary hypertension: Open label, multi centric, randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 试验地点
- 3
- 主要终点
- The six-minute walk distance obtained from the six-minute walk test
研究概览
简要总结
This study aims to test if yoga can be a safe and effective form of cardiac rehabilitation for patients with pulmonary hypertension. Due to limited access to traditional rehabilitation programs in India, yoga offers a low-cost and culturally acceptable alternative.
Patients will be divided into three groups:
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Control group: Receiving standard medical care,
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Intervention group1: Yoga based cardiac rehabilitation
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Intervention group 2: Following a home-based rehabilitation program.
The main outcome of the study is improvement in exercise capacity, which will be measured using the six-minute walk test.
Other important outcomes include:
Changes in quality of life, measured through a patient questionnaire
Changes in heart function, assessed by echocardiography
Levels of inflammation markers in the blood
Heart rate variability, to understand changes in the nervous system.
The study will help assess if yoga can be a practical and beneficial alternative to traditional cardiac rehabilitation for patients with pulmonary hypertension in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with pulmonary hypertension, defined as peak tricuspid regurgitation velocity of more than 3.5meters per second by 2 dimensional echocardiogram.
- •Stable on medications for 3 months prior to enrollment WHO functional class II and III 6MWD less than 440m.
排除标准
- •Patients who choose to get recruited in the cardiopulmonary rehabilitation program.
- •WHO functional class 1 and
- •Recent episode of syncope within less than 1 month.
- •Recent acute coronary event within less than 3 months Evidence of left heart failure.
- •Pregnant or planning to get pregnant in the study period.
- •Uncontrolled arrhythmia.
- •Unstable angina.
- •Practicing yoga regularly more or enrolled in cardiac rehabilitation program.
- •Participating in any other clinical trial Significant neuromuscular complications inhibiting participation in the trial.
- •Significant hepatic or renal dysfunction Enzymes more than 2 times normal or Serum creatinine more than 2 times.
结局指标
主要结局
The six-minute walk distance obtained from the six-minute walk test
时间窗: At baseline, three months and six months
次要结局
- high sensitivity CRP(At baseline and six months)
- Heartrate variability(At baseline and six months)
- WHO functional class(Baseline, three months and six months)
- Quality of life assessment using emPHasis 10 questionnaire(baseline, three months and six months)
- Cardiopulmonary exercise test(Baseline and six months)
- Echocardiogram(At baseline, three months and six months)
- N terminal pro brain natriuretic peptide(Baseline and six months)
- Interleukin 6(At baseline and six months)
研究者
Dr Prashant Bobhate
Kokilaben Dhirubai Ambani Hospital, Mumbai