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临床试验/CTRI/2024/03/064448
CTRI/2024/03/064448尚未招募不适用

Effect of exercise based cardiac rehabilitation on heart rate variability, functional exercise capacity and quality of life in patients with heart failure.

Ramaiah University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
: HRV, functional capacity (using 6MWD) and QOL (Kansas City Cardiomyopathy Questionnaire (KCCQ))

研究概览

简要总结

Cardiovascular diseases are the leading cause of death and disability in India. Marked reduction in exercise capacity has detrimental effects on activities of daily living, health-related quality of life. This leads to increased risk of mortality and hospital admission rate is high following a heart failure (HF), which may be due to gaps in secondary prevention in general and a lack of cardiac rehabilitation (CR) services in particular. Numerous cardiac rehabilitation studies have demonstrated functional benefits, improvement in quality of life, and clinical outcomes from exercise training in patients with heart failure. Autonomic dysfunction is an independent predictor of cardiovascular disease and mortality after heart failure. Heart rate variability (HRV) is a widely used, easy, non-invasive method that is reproducible and cost-effective for estimating cardiac autonomic modulation. A depressed HRV is a valuable indicator of autonomic dysfunction. Depressed HRV suggests poor functioning of cardiac autonomic modulation and thus impaired ability of the heart to adapt to a range of physiological and environmental stimuli. Low heart rate variability (HRV) is an indicator of increased risk of sudden cardiac death in patients with chronic heart failure.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  •  Males and Females aged above 18 years.
  •  Left ventricular ejection fraction < 40% (Assessed by 2D Echo) by Simpson’s method.
  •  Patients diagnosed with NYHA Class II and III Heart failure within 6 months.

排除标准

  •  Presence of any other diseases limiting life expectancy  Severe valvular diseases  Class IV HF  Recurrent ventricular arrythmias  End stage renal and liver disease  Subjects already involved in any form of exercise training programs or clinical trials.

结局指标

主要结局

: HRV, functional capacity (using 6MWD) and QOL (Kansas City Cardiomyopathy Questionnaire (KCCQ))

时间窗: : HRV, functional capacity (using 6MWD) and QOL (Kansas City Cardiomyopathy Questionnaire (KCCQ))

次要结局

未报告次要终点

研究者

发起方
Ramaiah University of Applied Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Veena Kiran Nambiar

M.S.Ramaiah medical college

研究点 (1)

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