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临床试验/NCT02765568
NCT02765568已完成不适用

Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
2
主要终点
Exercise Capacity

研究概览

简要总结

Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);
  • Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;
  • Patient is able to walk independently
  • Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
  • At least 40 years of age;
  • Patient is willing and able to provide informed consent

排除标准

  • Currently participating in routine exercise training (>2x/week) and/or using Nordic Walking poles;
  • Active infection or inflammatory condition;
  • Over 75 years of age;
  • Persistent or permanent atrial fibrillation;
  • Pregnant, lactating or planning to become pregnant during the trial period;
  • Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • Unable to read and understand English or French;
  • Unwilling or unable to return for follow-up visit at weeks 12 and 26;

结局指标

主要结局

Exercise Capacity

时间窗: Baseline to 12 weeks and Baseline to 26 weeks

Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test

次要结局

  • Functional Fitness(Baseline to 12 weeks and Baseline to 26 weeks)
  • Aortic stiffness(Baseline to 12 weeks and Baseline to 26 weeks)
  • Depression(Baseline to 12 weeks and Baseline to 26 weeks)
  • Quality of Life - HeartQoL(Baseline to 12 weeks and Baseline to 26 weeks)
  • Exercise Adherence(Baseline to 12 weeks and Baseline to 26 weeks)
  • Quality of Life - SF36(Baseline to 12 weeks and Baseline to 26 weeks)
  • Lipid and glucose profile(Baseline to 12 weeks and Baseline to 26 weeks)
  • Body Composition(Baseline to 12 weeks and Baseline to 26 weeks)
  • Depression mechanisms(Baseline to 12 weeks and Baseline to 26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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