Coronary Disease
Conditions
Keywords
High intensity interval training, Coronary heart disease, Exercise training, Cardiac rehabilitation, Interval training
Brief summary
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
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.
Interventions
OTHERHigh intensity interval training
High intensity interval training within a standard cardiac rehabilitation programme
Sponsors
Cardiff Metropolitan University
City Health Care Partnership CIC (Hull)
University of Hull
Aneurin Bevan University Health Board
Wake Forest University Health Sciences
Bangor University
University of Warwick
University Hospitals Coventry and Warwickshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria: 1. Successfully revascularised following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) 2. Angiographically documented non-obstructive coronary artery disease (CAD) 3. Left ventricular ejection fraction (LVEF) \> 40% 4. Clinically stable (symptoms and medication) for \> 2 weeks 5.18 - 75 yrs of age General
Exclusion criteria
1. Symptoms of ischemia 2. Significant left main stem stenosis 3. NYHA class III-IV symptoms 4. Compromising cardiac ventricular arrhythmia 5. Significant valvular heart disease 6. Inability to comply with guidelines for participation in exercise testing and training 7. Significant limiting comorbidities that would prevent full participation Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak oxygen uptake (VO2 peak) | Baseline, 8 weeks and 12 months | Cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological factors associated with compliance and adherence (1) | Baseline, 8 weeks | Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES) |
| Psychological factors associated with compliance and adherence (2) | Baseline, 8 weeks | Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2) |
| Psychological factors associated with compliance and adherence (3) | Baseline, 8 weeks | Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES) |
| Psychological factors associated with compliance and adherence (4) | Baseline, 8 weeks | Quantitative psychology - questionnaires: 4) Courneya and Bobick's 7-point bipolar adjectival rating scale; |
| HR-QOL | Baseline, 8 weeks and 12 months | Questionnaire - EQ-5D-5L |
| Service and resource use | Baseline, 8 weeks and 12 months | Questionnaire - client service receipt inventory (CSRI) |
| Compliance and adherence | Every exercise session (8 week exercise programme duration) | 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. |
| Metabolic reserve | Baseline, 8 weeks and 12 months | Cardiopulmonary exercise test - ventilatory threshold (VT) |
| Ventilatory efficiency | Baseline, 8 weeks and 12 months | Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope) |
| Cardiac remodelling | Baseline, 8 weeks and 12 months | Echocardiography - left ventricular volumes |
| Arterial remodelling | Baseline, 8 weeks and 12 months | Arterial oscillometry - pulse wave velocity |
| Cardiovascular health | Baseline, 8 weeks and 12 months | CHD risk factor assessment |
| Palatability | 8 weeks | Qualitative psychology - thematic analysis of semi structured interviews |
| Lifestyle physical activity | Baseline, 8 weeks and 12 months | Physical activity monitor (worn for 1 week) - total energy expenditure |
Countries
United Kingdom
Outcome results
None listed