High Intensity Interval Training (HIIT) Versus Moderate Intensity Steady State Training (MISS) in UK Cardiac Rehabilitation Programmes: a Multi-centre Randomised Controlled Trial and Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Change in peak oxygen uptake (VO2 peak)
研究概览
简要总结
The purpose of the trial is to compare the effects of high intensity interval training (HIIT) with usual care - moderate intensity steady state training (MISS) - in UK cardiac rehabilitation (CR) programmes.
详细描述
Current cardiac rehabilitation (CR) guidelines recommend moderate intensity, steady state exercise training (MISS). However, this guideline predates significant advances in interventional and medical treatment for coronary heart disease (CHD) and may not, therefore, be the most effective strategy for the 'modern' patient with CHD. Recent research has indicated that greater benefit may be attained by participating in high intensity interval training (HIIT) which involves repeated short bursts of harder exercise interspersed with short recovery periods. Studies suggest that this can be performed without any compromise in exercise adherence or patient safety. The benefit of this approach in 'real world' CR programmes in the UK cannot be confirmed, as studies have been predominantly conducted in the laboratory and exclusively outside the UK.
In patients attending CR programmes in the UK, the investigators hypothesise that HIIT will improve VO2 peak to a greater extent than MISS. The investigators also hypothesise that HIIT will: 1) be more palatable than MISS and demonstrate greater patient compliance and adherence; 2) improve cardiovascular health to a greater extent than MISS; 3) improve HR-QoL to a greater extent than MISS; 4) lead to more positive motivation and attitudes to exercise than MISS; 5) increase short and medium-term participation in lifestyle physical activity to a greater extent than MISS; 6) be a cost effective alternative to MISS; 7) be as safe as MISS.
The HIIT or MISS study is a pragmatic single-blind, multi-centre, longitudinal, randomised controlled trial. Participants will be randomly allocated to 8 weeks of HIIT or MISS (usual care). Outcomes will be assessed at baseline, 8 weeks and 12 months by assessors blinded to group allocation. Study interventions will be delivered by clinical (not research) staff.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in peak oxygen uptake (VO2 peak)
时间窗: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test
次要结局
- Psychological factors associated with compliance and adherence (3)(Baseline, 8 weeks)
- Psychological factors associated with compliance and adherence (4)(Baseline, 8 weeks)
- Arterial remodelling(Baseline, 8 weeks and 12 months)
- Service and resource use(Baseline, 8 weeks and 12 months)
- Compliance and adherence(Every exercise session (8 week exercise programme duration))
- Psychological factors associated with compliance and adherence (1)(Baseline, 8 weeks)
- Psychological factors associated with compliance and adherence (2)(Baseline, 8 weeks)
- HR-QOL(Baseline, 8 weeks and 12 months)
- Metabolic reserve(Baseline, 8 weeks and 12 months)
- Cardiac remodelling(Baseline, 8 weeks and 12 months)
- Palatability(8 weeks)
- Lifestyle physical activity(Baseline, 8 weeks and 12 months)
- Ventilatory efficiency(Baseline, 8 weeks and 12 months)
- Cardiovascular health(Baseline, 8 weeks and 12 months)