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临床试验/CTRI/2017/09/009925
CTRI/2017/09/009925已完成不适用

Evaluation of Autonomic tone, Vascular and Endothelial function in Myocardial Infarction Patients undergoing Yoga based Cardiac Rehabilitation

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Heart rate variability (HRV),

研究概览

简要总结

The therapeutic landscapes of yoga are diverse. Several studies have shown that yoga and meditation control risk factors for cardiovascular disease like hypertension, type II diabetes and insulin resistance, obesity, lipid profile, psychosocial stress and smoking. Some randomized studies suggest that yoga / meditation could retard or even regress early and advanced coronary atherosclerosis.

CR is the process of restoring desirable levels of physical, social, and psychological functioning after the onset of cardiovascular illness. The aims of CR programmes are to optimise patient’s functioning, enhance quality of life, and minimise the risk of recurrent cardiac events. Comprehensive CR programmes are multi-component interventions, which include elements of exercise training, relaxation and stress management, secondary prevention, and pay attention to the patient’s psychosocial adjustment.  Yoga covers most of the elements of a comprehensive CR programme: improved physical fitness, stress reduction and lifestyle. The proposed research is to understand the mechanism behind the effects of Yoga based cardiac rehabilitation on autonomic, vascular and endothelial functions in patients following Acute Myocardial Infarction. Most of the studies on yoga are limited to healthy subjects and diseased conditions other than myocardial infarction. This study is unique in that there is deficiency of data on the effect of yoga based cardiac rehabilitation in acute Myocardial infarction patients. Therefore, this study proposes to test the mechanisms underlying the effects of Yoga-Cardiac Rehabilitation program in patients with acute myocardial infarction to suggest a road map for future enhancement of Yoga based Cardiac rehabilitation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

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 MI
  • Willingness to attend the yoga sessions.

排除标准

  • Patients who regularly practice yoga
  • Current participation in other clinical trials
  • Severe valvular diseases, arrhythmias, heart failure (Killip class IV), end stage renal diseases and end stage liver diseases.

结局指标

主要结局

Heart rate variability (HRV),

时间窗: Baseline - 3 weeks post MI | Intervention - 3 Months | Post intervention - at the end of 3rd month | follow up - 3 months after intervention

Blood Pressure Variability (BPV),

时间窗: Baseline - 3 weeks post MI | Intervention - 3 Months | Post intervention - at the end of 3rd month | follow up - 3 months after intervention

Baroreflex Sensitivity (BRS), Pulse wave velocity (PWV),

时间窗: Baseline - 3 weeks post MI | Intervention - 3 Months | Post intervention - at the end of 3rd month | follow up - 3 months after intervention

Augmentation Index (AIx), Flow mediated dilatation (FMD)

时间窗: Baseline - 3 weeks post MI | Intervention - 3 Months | Post intervention - at the end of 3rd month | follow up - 3 months after intervention

次要结局

  • Echocardiography(Baseline - 3 weeks post MI)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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