High Intensity Interval Training in UK Cardiac Rehabilitation Programmes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Disease

Intervention / Treatment
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* Other: High intensity interval training


Participation Criteria
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Eligibility Criteria
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General inclusion criteria: Successfully revascularised following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) Angiographically documented non-obstructive coronary artery disease (CAD) Left ventricular ejection fraction (LVEF) > 40% Clinically stable (symptoms and medication) for > 2 weeks 5.18 - 75 yrs of age General exclusion criteria: Symptoms of ischemia Significant left main stem stenosis NYHA class III-IV symptoms Compromising cardiac ventricular arrhythmia Significant valvular heart disease Inability to comply with guidelines for participation in exercise testing and training Significant limiting comorbidities that would prevent full participation Additional exclusion criteria: Further to the analysis of cardiopulmonary exercise test and echocardiography at baseline, and prior to randomisation, patients will be prevented from continuing their involvement in the study if there is indication of: Exercise induced ischemia or significant hemodynamic compromise LVEF < 40% Clinical instability in accordance with CR guidelines Inability to comply with guidelines for participation in exercise testing and training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care cardiac rehabilitation with exercise training as per current guidelines Warm up: 15 mins, < 40% heart rate reserve (HRR) Cardiovascular component: progress towards 20 - 40 mins continuous cardiovascular exercise at 40-70% HRR. Muscular strength and endurance programme. Cool down: 10 mins, < 40% HRR. Initial duration based on participant's previous and current physical activity (PA) levels and cardiopulmonary exercise test (CPEX) performance. Duration and workload of cardiovascular component adjusted, as tolerated, within the above parameters, in response to exercising heart rate (HR), participant reported rating of perceived exertion (RPE) and symptoms. | |
| Experimental: High intensity interval training<br>High intensity interval training within a standard cardiac rehabilitation programme. Warm up: 15 mins total, 10 mins <40-70% HRR, 5 mins <70% HRR. Cardiovascular component: exercise bike interval training: 10 x high @ 85-90% peak power output (PPO) from CPEX, 10 x low @ 20-25% PPO (exercise intensity will not to be prescribed from gas exchange data i.e. %VO2 peak). Change in intensity from low to high achieved by altering cadence (rpm). Muscular strength and endurance programme. Cool down: 10 mins, <40% HRR. Duration of intervals and total programme duration increased in a standardised fashion. Workload increased bi-weekly in response to participant reported RPE (only after the full 10 x 1 protocol has been achieved). If RPE < 17 then workload will be increased. | Other: High intensity interval training<br>* High intensity interval training within a standard cardiac rehabilitation programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen uptake (VO2 peak) | Cardiopulmonary exercise test | Baseline, 8 weeks and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and adherence | Compliance and adherence will be determined by recording the number of training sessions attended and successfully completed in accordance with the exercise protocol. Drop-out from the programme will also be documented for both study groups in addition to reason for drop-out, where provided voluntarily by participants. | Every exercise session (8 week exercise programme duration) | 
| Psychological factors associated with compliance and adherence (1) | Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES) | Baseline, 8 weeks | 
| Psychological factors associated with compliance and adherence (2) | Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2) | Baseline, 8 weeks | 
| Psychological factors associated with compliance and adherence (3) | Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES) | Baseline, 8 weeks | 
| Psychological factors associated with compliance and adherence (4) | Quantitative psychology - questionnaires: 4) Courneya and Bobick's 7-point bipolar adjectival rating scale; | Baseline, 8 weeks | 
| HR-QOL | Questionnaire - EQ-5D-5L | Baseline, 8 weeks and 12 months | 
| Service and resource use | Questionnaire - client service receipt inventory (CSRI) | Baseline, 8 weeks and 12 months | 
| Lifestyle physical activity | Physical activity monitor (worn for 1 week) - total energy expenditure | Baseline, 8 weeks and 12 months | 
| Metabolic reserve | Cardiopulmonary exercise test - ventilatory threshold (VT) | Baseline, 8 weeks and 12 months | 
| Ventilatory efficiency | Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope) | Baseline, 8 weeks and 12 months | 
| Cardiac remodelling | Echocardiography - left ventricular volumes | Baseline, 8 weeks and 12 months | 
| Arterial remodelling | Arterial oscillometry - pulse wave velocity | Baseline, 8 weeks and 12 months | 
| Cardiovascular health | CHD risk factor assessment | Baseline, 8 weeks and 12 months | 
| Palatability | Qualitative psychology - thematic analysis of semi structured interviews | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High intensity interval training, Coronary heart disease, Exercise training, Cardiac rehabilitation, Interval training