Effectiveness of Yoga based Cardiac Rehabilitation (Yoga-CaRe) in Heart Failure: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 10
- 主要终点
- Co-primary outcome -1
研究概览
简要总结
Cardiac rehabilitation programme, a Class-I indication for patients with heart failure is virtually non-existent in India. India is home to millions of people with heart failure. A structured, culturally appropriate cardiac rehabilitation model suitable for India is lacking. Yoga has been widely used in clinical settings for its potential cardiovascular benefits among others. However, conclusive evidence on the effect of Yoga based cardiac rehabilitation programme in patients with heart failure is not established through adequately powered randomized controlled trials on several important outcomes such as clinical endpoints such as all-cause mortality and all-cause hospitalisation, patient-reported outcomes such as disease-specific quality of life outcomes, disease specific functional outcome measures such as six-minutes’ walk testand the mchanistic pathways through which Yoga-CaRe could exert benefits are not adequately explored.
The specific objectives of the research study are
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To develop a Yoga-based Cardiac Rehabilitation programme (Yoga-CaRe) for patients with Heart Failure following a systematic process.
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To test the effectiveness Yoga-CaRe programme on cardiovascular events and quality of life in a multi-centre randomized controlled trial
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To evaluate the mechanism behind the potential benefits of yoga in a mechanistic sub-study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and female patients above 18years Physician diagnosed heart failure patients based on ESC guidelines 2 Patients should be NYHA class II and or III 3 Willing and able to attend the complete hospital-based CR programme on their own Diagnosis of Heart Failure will be based on the European Society of Cardiology ESC Guidelines.
- •The diagnosis of HF-REF requires three conditions to be satisfied 1 Symptoms typical of Heart Failure 2 Signs typical of Heart Failure 3 Reduced Left Ventricular Ejection Fraction.
排除标准
- •1 Comorbid disease or behavioural or other limitations that interfere with performing Yoga training or prevent the completion of 1 year of exercise training 2 Elective Cardiovascular procedure or hospitalization planned in the coming 3 months 3 Currently pregnant or intend to become pregnant in the next year 4 Heart failure secondary to significant correctable/reversible cause like primary valvular disease or correctable congenital heart disease 5 Performance of exercise training/yoga at regular intervals (more than once per week) at a moderate-to-vigorous intensity at any time in the previous six weeks 6 Participation in other clinical trial.
结局指标
主要结局
Co-primary outcome -1
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
Major adverse cardiovascular events which is a composite
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
of all-cause mortality, nonfatal stroke and all cause hospitalisations at a median follow-up of one
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
year
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
Co-primary outcome-2
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire MLHFQ at three months
时间窗: Co-primary outcome-1 | Median follow-up of one | year and Co-primary outcome-1 | Three months
次要结局
- Six-minute walk test 6MWT(3 and 6 months)
- Cardiovascular mortality at end of trial follow-up(Median Follow-up 1 year)
- Heart Failure Specific Hospitalisation at end of trial follow-up(Median Follow-up 1 year)
- Quality of life as measured by MLHFQ(6 months and 12 months)
- Self rated health as measured by European Quality of Life Questionnare EQ-5D-5L(3 and 6 months)
- Smoking Cessation(3 months and 1 year)
- Adherence to prescribed therapy(Three months and final follow-up (median 1 year))
- Self reported frailty as reported by Fried Frailty Phenotype tool(3 and 6 months)
- Cost effectiveness(Median Follow-up 1 year)
- Quality of life and depression among care-givers(3 months and 6 months)
- Safety outcomes(Median Follow-up 1 year)