Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- SF-36 quality of life
研究概览
简要总结
Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.
详细描述
Study design :
Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two parallel groups
- Arm control workshops around social activities
- Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.
Population concerned :
Patients with stabilized chronic heart failure (last episode of acute heart failure dating back more than a month) followed at the Pitié Salpêtrière cardiology institut
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥18 years old
- •Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of measurement method)
- •Stabilized (last episode of acute heart failure dating back more than a month) in NYHA stage I to III dyspnoea, ambulatory, discharged from hospital for > 1 month
- •Drug treatment optimized according to the judgment of the investigator
- •Ability to participate in activities as proposed (remote or face-to-face)
- •Patient affiliated with a social security scheme
- •Written consent to participate
排除标准
- •Patients who have practiced yoga regularly (> once a month) in the six months prior to selection.
- •Current pregnancy / lactation
- •Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or severe curable valve disease
- •Severe renal impairment GFR<25ml/min/1.73 m2 or on dialysis.
- •Persons subject to legal protection measures (guardianship, curatorship)
- •Person not "receptive" to the practice of yoga
- •Participation in intervention research
结局指标
主要结局
SF-36 quality of life
时间窗: at day 0 and maximum at 5 month
The SF-36 quality of life self-questionnaire is one of the most widely used questionnaires to assess the quality of life of patients. Its result is between 0 and 100. It includes a physical summary score and a psychological summary score.
次要结局
- Weight (kg)(at day 0 and maximum at 5 month)
- Heart rate (Bpm)(at day 0 and maximum at 5 month)
- Score Hospital Anxiety and Depression Scale (HAD)(at day 0 and maximum at 5 month)
- Waist circumference (cm)(at day 0 and maximum at 5 month)
- Concentration of Nt-pro BNP Biomarker(3 months before inclusion and maximum 7 months after inclusion)
- Blood pressure (mmHg)(at day 0 and maximum at 5 month)
- NYHA assessment(at day 0 and maximum at 5 month)
- Concentration of CRP Biomarkers(3 months before inclusion and maximum 7 months after inclusion)
- Distance during 6-minute walk test(3 months before inclusion and maximum 7 months after inclusion)
- VO2 charge level(3 months before inclusion and maximum 7 months after inclusion)
- First ventilatory load level(3 months before inclusion and maximum 7 months after inclusion)
- Concentration IL6 Biomarkers(3 months before inclusion and maximum 7 months after inclusion)
- Peak VO2(3 months before inclusion and maximum 7 months after inclusion)
- VE/VCO2(3 months before inclusion and maximum 7 months after inclusion)
- First ventilatory threshold(3 months before inclusion and maximum 7 months after inclusion)