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临床试验/NCT05195788
NCT05195788Enrolling By Invitation不适用

Investigating the Impact of Cardiac Rehabilitation on Brain Activity and Cognition in Adults With Congenital Heart Disease

Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
2
主要终点
Change in brain hemodynamics

研究概览

简要总结

The proposed trial is designed to evaluate the effect of an individualised cardiac rehabilitation program, consisting of aerobic and muscle strengthening exercises, on brain activity and cognitive functions in adults with congenital heart disease

详细描述

Thanks to advances in medical research, individuals born with heart defects (Congenital Heart Disease: CHD), are now 95% more likely to reach adulthood, with around 250,000 adults with CHD currently living in Canada. CHD-related diseases and conditions are extremely common in the adult CHD population, and undermine the successes achieved by medical research. For example, compared to healthy peers, adults with CHD are between 3 to 6 times more likely to experience heart accidents or develop other heart conditions during lifetime. Adults with CHD also have more health problems, and have between 1.5 and 2 increased risk of precocious cognitive decline and dementia. Better lifestyle choices and management of medical risk factors play a crucial role in preventing such problems and in increasing the quality of life of those living with CHD. In this regard, physical activity has been suggested as one of the most cost-effective methods for decreasing mortality and incidence of cardiovascular diseases related to CHD. An increasing body of studies have shown that both physical activity and exercise training improve physical and mental health in adults with CHD, who typically tend to be less active than healthy adults. Although physical activity and exercise training have been shown to enhance cognition and brain activity in individuals with other cardiovascular diseases, such effects in CHD are yet to be investigated.

In the present project, the impact of a cardiac rehabilitation program on brain activity and on cognitive functions will be explored in adults with moderate and severe forms of CHD. The 3-month intervention will include an individualised program consisting of combined aerobic and muscle strengthening exercises provided by certified kinesiologists, to be completed at the research center and at home (hybrid program). Brain imaging technology (fNIRS) will be used to measure changes in brain activity related to the intervention. The benefits on cognitive functions, such as attention, executive functions and memory, will be measured with standardized neuropsychological tests before and after the intervention. The results of this project will contribute to a better understanding of the many benefits of exercise training in individuals with CHD, and will lay the foundations for optimal interventions, targeted to prevent CHD-related conditions and impairments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • being able to read, understand and sign the information and consent form;
  • being aged 18 or more at the time of consent;
  • having a diagnosis of congenital heart disease with moderate or severe risk;
  • being referred to the EPIC center in cardiovascular rehabilitation;
  • being able to perform a maximal cardiopulmonary stress test and an exercise training program in accordance with current recommendations for cardiovascular rehabilitation;
  • having Internet access.

排除标准

  • recent major cardiovascular events or interventions <3 months;
  • uncontrolled mental or psychiatric disorder in the last 6 months;
  • genetic syndromes affecting cognition;
  • excessive alcohol consumption (> 15 drinks / week);
  • current participation in other clinical trials;
  • contraindication to stress testing and / or physical training;
  • severe intolerance to physical exercise.

结局指标

主要结局

Change in brain hemodynamics

时间窗: Baseline, post-intervention at 3 months

Neurovascular coupling (Stroop task). This component will be investigated at the cortical level using functional near infrared spectroscopy (fNIRS), and measured in changes in hemodynamics (oxygenated hemoglobin concentration).

次要结局

  • Changes in episodic memory(Baseline, post-intervention at 3 months)
  • Changes in executive functions(Baseline, post-intervention at 3 months)
  • Changes in processing speed(Baseline, post-intervention at 3 months)
  • Changes in general cognitive functioning(Baseline, post-intervention at 3 months)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Bherer

Associate Scientific Director, Direction of Prevention

Montreal Heart Institute

研究点 (2)

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