跳至主要内容
临床试验/NCT05434117
NCT05434117进行中(未招募)不适用

Feasibility and Preliminary Efficacy of High-intensity Interval Nordic Walking in Patients With Coronary Artery Disease: A Pilot Randomized Clinical Trial (HIIT-NoW)

Ottawa Heart Institute Research Corporation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Self-efficacy

研究概览

简要总结

Coronary revascularization, such as heart bypass surgery (CABG) and percutaneous coronary intervention (PCI [inserting a stent to open up blood vessels]) improve survival for people with coronary artery disease. Yet, many patients suffer from poor physical and mental health after coronary revascularization. Traditional cardiac rehabilitation involving moderate-to-vigorous intensity continuous training (MICT) improves physical and mental health. However, alternative exercise programs, such as high-intensity interval training (HIIT) and Nordic walking may provide superior benefits. Nordic walking is like Nordic skiing but uses specifically designed poles for walking. Nordic walking involved core, upper and lower body muscles, resulting in greater energy expenditure while reducing loading stress at the knee. To date, HIIT used in cardiac rehabilitation settings has focused on lower body (e.g., leg cycling). The investigators are not aware of HIIT protocols that target both upper and lower body at the same time. An exercise program that combines HIIT and Nordic walking (HIIT-NoW) may offer an alternative time-efficient whole-body exercise to improve physical and mental health. This study will test if HIIT-NoW can be an alternative exercise option to improve physical and mental health in patients with coronary artery disease.

详细描述

Coronary revascularization improves survival for patients with coronary artery disease (CAD). Despite successful coronary revascularization treatment, however, many patients with CAD are left suffering from poor exercise capacity and frequently experience difficulties in performing daily activities (e.g., getting dressed, sitting down or getting up from the toilet) because of diminished cardiovascular function and exercise tolerance. Decreased exercise capacity leads to a dramatic reduction in quality of life (QoL) and more severe depression symptoms. Low exercise capacity, poor quality of life (QoL) and severer depression symptoms heighten the risk of subsequent cardiovascular events and mortality.

Current guidelines recommend that persons with CAD who have undergone coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) participate in exercise-based cardiovascular rehabilitation (CR). Exercise-based CR is safe, effective and a class IA recommendation following CABG and PCI. Irrefutable evidence demonstrates that exercise-based CR including moderate-to-vigorous intensity continuous exercise training (MICT) improves exercise capacity, QoL, depression and reduces hospital readmissions and cardiovascular morbidity and mortality. MICT has long been used to manage the physical and mental health of CAD patients as per the Canadian Guidelines for Cardiovascular Rehabilitation and Cardiovascular Disease Prevention; however, such exercise may be less efficient and perceived as less motivating/enjoyable. Growing evidence suggests that non-conventional exercise interventions, such as high-intensity interval training (HIIT) and Nordic walking are more effective exercise modalities, and maybe more enjoyable, to improve clinical outcomes (e.g., exercise capacity, QoL, and depression symptoms) in patients with CAD.

HIIT (repeated bouts of brief high-intensity exercise interspersed with active recovery) is an effective and efficient exercise training paradigm. A recent meta-analysis (n=10 studies) comparing HIIT and MICT in patients with CAD suggests that: (1) HIIT is superior to MICT in improving cardiorespiratory fitness (V̇O2peak) of patients with CAD, an important clinical vital sign and strong predictor of mortality; and, (2) HIIT and MICT are equally effective in improving QoL and depression symptoms in patients including CAD. Increases in cardiorespiratory fitness decrease mortality risk -- every 3.5 ml/kg/min increase in V̇O2peak yields a 13% improvement in survival. Exercise training-induced increases in cardiorespiratory fitness are therefore highly desirable for the improvement of important patient outcomes.

Nordic walking is similar to Nordic skiing but uses specifically designed poles for walking. Nordic walking includes the recruitment of core, upper and lower body muscles, resulting in greater exergy expenditure while reducing loading stress at the knee joint. Regular participation in Nordic walking leads to increased exercise capacity. Although data is limited regarding the impact of Nordic walking in comparison to MICT on mental health in patients with CAD, some studies in patients with heart failure have shown superior improvements in QoL and fewer depressive symptoms following Nordic walking when compared to MICT. Our previous randomized controlled trial simultaneously comparing 12 weeks of supervised HIIT, MICT and Nordic walking in patients with CAD showed that Nordic walking was statistically and clinically superior in increasing functional capacity (i.e., distance walked over 6 minutes), and have similar effects on QoL and depression when compared to HIIT or MICT.

As many adults with cardiovascular disease consider lack of time a barrier to exercise, HIIT may be an appealing exercise training paradigm as cardiovascular health benefits can be achieved in less time when compared to MICT. HIIT may also address other frequently reported deterrents to MICT, including lack of interest and motivation, boredom, not challenging enough, and tailored for older people's needs. To date, HIIT used in CR settings has predominantly focused on lower body (e.g., leg cycling). There are few HIIT protocols that simultaneously target both upper and lower body, such as high-intensity interval Nordic walking (HIIT-NoW). Studies have shown that HIIT and Nordic walking are feasible, enjoyable and have similar or superior effects on physical and mental health when compared to MICT. By combining HIIT and Nordic walking, HIIT-NoW may offer an alternative time-efficient whole-body exercise to improve physical and mental health of patients with CAD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcome variables will be assessed by study personnel who are blinded to patient allocation.

入排标准

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

入选标准

  • patients with coronary artery disease treated with PCI or CABG;
  • willing to come onsite for exercise sessions;
  • able to perform a cardiopulmonary exercise testing (CPET); and,
  • at least 40 years of age.

排除标准

  • currently participating in a CR program;
  • unstable angina or established diagnosis of atrial fibrillation, chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; or,
  • unable to return for 10-week follow-up visit.

研究组 & 干预措施

High-intensity interval Nordic walking

Experimental

Participants will receive high-intensity interval Nordic walking training.

干预措施: High-intensity interval Nordic walking (Behavioral)

Control

Active Comparator

Participants will undergo standard cardiovascular rehabilitation.

干预措施: Standard cardiovascular rehabilitation (Behavioral)

结局指标

主要结局

Self-efficacy

时间窗: Baseline to week 11 follow up

Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.

Recruitment

时间窗: Baseline to week 11 follow up

Recruitment will be assessed for feasibility. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study

Adverse events

时间窗: Baseline to week 11 follow up

Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.

Subjective exercise experiences

时间窗: Baseline to week 11 follow up

Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.

Adherence

时间窗: Baseline to week 11 follow up

Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions

Compliance

时间窗: Baseline to week 11 follow up

Compliance will be assessed for feasibility. Compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. All HIIT-NoW sessions will be monitored by study personnel and compliance to prescribed exercise intensity will be assessed for each exercise session.

次要结局

  • Functional capacity(Baseline to week 11 follow up)
  • Fat mass(Baseline to week 11 follow up)
  • Cardiorespiratory fitness(Baseline to week 11 follow up)
  • Quality of life (QoL)(Baseline to week 11 follow up)
  • Subjective functinal capacity(Baseline to week 11 follow up)
  • Fat-free mass(Baseline to week 11 follow up)
  • Waist circumference(Baseline to week 11 follow up)
  • Physical activity levels(Baseline to week 11 follow up)
  • Heart Disease specific Quality of life (HeartQoL)(Baseline to week 11 follow up)
  • Depression(Baseline to week 11 follow up)
  • Blood pressure(Baseline to week 11 follow up)
  • Gender(Baseline to week 11 follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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