Effectiveness of Yoga-based Cardiac Rehabilitation (Yoga-CaRe) in Heart Failure: An Apple-Watch Enabled Physiological Sub-study of Yoga-CaRe HF trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Co-primary outcome -1 Major adverse cardiovascular events which is a composite of all-cause mortality, nonfatal stroke and all cause hospitalisations at a median follow-up of one year
研究概览
简要总结
400 patients with heart failure and reduced ejection fraction aged 18 and above from the ongoing Yoga-CaRe HF trial from selected tertairy centres. Yoga-CaRe HF trial is a randomzied conrtolled trial evaluating the effects of yoga based cardiac rehabilitation in patients with heart failure and reduced ejection fraction (NYHA clasee II & III) in 3500 patients recruied from 15 hospitals arooss the country. The primary outcomes are the major adverse cardiovascular events and quality of life. The trial ongoing with near 2000 participant recruitment as on 02-09-2024.
In this sub-study, we will use Apple Watches (series 8 and after) to correlate these well-characterized physiological markers like sleep duration, Deep sleep, Atrial fibrillation episodes with information derived from accelerometry, such as step count and activity such as total energy spent, active energy spent, walking and running distance etc., photoplethysmography, such as heart rate, heart rate variability, and heart rhythm, sleep patterns, energy expenditure and specialized physiological measures occasionally available, such as a 1-lead electrocardiogram (ECG) and oxygen
These test will be conducted at baseline, three months and at six months.
These investigations will help in exploring the direct effects of Yoga-CaRe on heart functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 interferew ith 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 Major adverse cardiovascular events which is a composite of all-cause mortality, nonfatal stroke and all cause hospitalisations at a median follow-up of one year
时间窗: Co-primary outcome-1 Median follow-up of one year and Co-primary outcome-2 Three months
Co-primary outcome-2 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-2 Three months
次要结局
- 1.Sleep duration(2.Deep sleep)
研究者
Prof Dorairaj Pabhakaran MD DM Msc
Centre for Chronic Disease Control