Investigating the Effectiveness and Acceptability of Isometric Handgrip Training in Remote Cardiac Rehabilitation Patients: A Randomized Controlled Trial With an Embedded Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Reduction in Resting Blood Pressure
研究概览
简要总结
Research has shown that isometric (constant squeeze) exercise training using an isometric handgrip (IHG) device lowers resting blood pressure (BP) in those with and without high BP. The purpose of this study is to explore if IHG training will lower resting BP in people doing cardiac rehabilitation more than doing only cardiac rehabilitation. Once eligibility is confirmed participants will be randomly assigned to one of two groups for the study. One group will do IHG training in addition to cardiac rehabilitation (Group 1), and the other group will do only cardiac rehabilitation (Group 2). Participants assigned to Group 1 will be asked to do IHG training on their own with an inflatable ball three days per week for 12 weeks with intensity set based on rating of perceived exertion (RPE) or rating of effort. Participants will self-measure and report their resting BP to investigators. The acceptability of doing IHG training will also be explored by conducting interviews with participants as will the impact that IHG training may have on psychological wellbeing by administering surveys to participants.
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
- 否
入选标准
- •Component adult (greater ≥ 18 years) who can provide informed consent.
- •Proficient in English (speaking, writing, and reading).
- •Medically cleared by the cardiac rehabilitation program to participate in exercise-based cardiac rehabilitation.
- •History of only coronary artery disease, the most common cardiovascular disease (CVD), which may include individuals with a previous myocardial infarction and/or procedure such as a percutaneous coronary intervention and/or coronary artery bypass grafting.
- •Minimum of "blue" level of technology capability (assigned by the cardiac rehabilitation program) indicating ability to use a phone and email for correspondence. Note: The majority of individuals who enroll in the cardiac rehabilitation program are assigned to this level.
- •No physical limitation(s) that would hinder the performance of isometric handgrip training.
- •Access to a blood pressure monitoring device to record at home measures.
排除标准
- •If the participant does not meet the inclusion criteria (identified above).
- •Moreover if an individual has a history of a CVD or disease-related complications (e.g., heart failure, atrial fibrillation, ventricular arrhythmias, aortic aneurysm, valve repair and/or replacement) and/or related procedures (e.g., placement of a pacemaker and/or implantable cardiac defibrillator) that is not coronary artery disease (as described in the inclusion criteria) they will be excluded.
- •Note: Individuals may have other comorbidities.
结局指标
主要结局
Reduction in Resting Blood Pressure
时间窗: 12 weeks
Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention
次要结局
- User Experience of IHG(12 weeks)
- Psychological state(12 weeks)