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临床试验/CTRI/2021/10/037127
CTRI/2021/10/037127尚未招募不适用

Impact of acute and chronic regular exercise on arterial stiffness and reflection measures in coronary artery disease patients

Jayoti Vidyapeeth Womens University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月10日最近更新:
适应症

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
The primary objective of this research is to identify whether long term exercise can beneficially modify hemodynamic profile especially pulse wave velocity and augmentation index in subjects with Coronary artery disease

研究概览

简要总结

Cardiovascular disease (CVD) is predicted as theleading cause of death worldwide until 2030 with measures for early detectionand progress monitoring essential to manage the condition and its associatedhealth costs. In the developed world, much progress has alreadybeen made in the fight against heart disease. However, death ratedue to cardiovascular diseases continuously increasing in the developing partof the world since last 50 years.  InIndia, many studies had reported soar in the cardiovascular disease incomparison to last 60 years from 1% to 9-10% in urban areas and <1% to 4%-6%in rural locations. Further, coronary heart disease is still theleading cause-of-death for both men and women in India. In contrast to 1990,mortality among men and women has raised by 31% and 13% in 2015. For men and women, coronary heart disease is listed at number one, followed bypulmonary disorders and cancer respectively. Vascular stiffness dueto arteriosclerosis may reduce arterial elasticity which is as an independent, non-invasive predictor of future incidence of coronary heart disease, stroke, andmortality. Further, greater vascular stiffness has been considered asone of the leading signs of vascular damage leading to CVD. 

This current project willdetermine the acute and chronic effects of 8-weeks of aerobic, resistance andcombined exercise on arterial hemodynamic function (i.e. PWV, AIx) in thosewith coronary artery disease.

AIMS

1.     Toexamine the impact of acute aerobic exercise on arterial stiffness measures inpatients with CAD;

2.     Toexamine the impact of chronic exercise training on resting and post-exercise arterialstiffness measures in patients with CAD;

3.     Toidentify the mechanisms (e.g. blood pressure, heart rate, NO availability,endothelial function) by which acute/chronic aerobic exercise alters arterialstiffness in patients with CAD;

EXPECTED RESEARCH CONTRIBUTION

Our research will help to identify whether long term exercise canbeneficially modify hemodynamic profile especially PVW and AIx in subjects withCAD. In addition, it will investigate the mechanisms for such benefits toimprove CVD risk for patients with CAD.

This study will be a prospective,single-blind, randomised controlled study examining the effects of exercise onarterial stiffness. Patients with CAD (n=60-80; 15-20 per group) will berandomised to one of four treatment groups (aerobic exercise, resistance exercise,combined aerobic and resistance exercise, and no exercise).  The three exercise groups will undertake 8weeks of supervised training, three times a week in accordance with recommendedguidelines (ACSM). The non-exercise groups will undertake no exercise training.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •the presence of CAD, which is defined as the patient having at least one of the following: angiographically documented stenosis ≥50% in at least one major coronary artery; prior history of myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CAGB) surgery; positive exercise stress test determined by a positive nuclear scan, or symptoms of chest discomfort accompanied by electrocardiographic (ECG) changes of > 1mm horizontal or down sloping ST segment depression.

排除标准

  • •non-cardiac surgical procedure within two months, MI or CABG within two months, PCI within one month, NYHA class II-IV symptoms of heart failure, documented valve stenosis, documented severe chronic obstructive pulmonary disease, symptomatic peripheral arterial disease, unstable angina, uncontrolled hypertension, uncontrolled atrial arrhythmia or ventricular dysrhythmia, insulin requiring diabetes mellitus, and any musculoskeletal abnormality that would limit exercise participation.

结局指标

主要结局

The primary objective of this research is to identify whether long term exercise can beneficially modify hemodynamic profile especially pulse wave velocity and augmentation index in subjects with Coronary artery disease

时间窗: 4 weeks and 8 weeks

次要结局

  • This study will further investigate the mechanisms for changes in hemodynamic profile benefits to improve CVD risk for patients with CAD(4 weeks and 8 weeks)

研究者

发起方
Jayoti Vidyapeeth Womens University
申办方类型
Other [self sponsored study]

研究点 (1)

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