University Hospital
Coventry, CV2 2DX, United Kingdom
NCT Number: NCT02784873
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Coventry, CV2 2DX, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General inclusion criteria:
General exclusion criteria:
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:
High intensity interval training within a standard cardiac rehabilitation programme
Time frame: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test
Time frame: 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.
Time frame: Baseline, 8 weeks
Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES)
Time frame: Baseline, 8 weeks
Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
Time frame: Baseline, 8 weeks
Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES)
Time frame: Baseline, 8 weeks
Quantitative psychology - questionnaires: 4) Courneya and Bobick's 7-point bipolar adjectival rating scale;
Time frame: Baseline, 8 weeks and 12 months
Questionnaire - EQ-5D-5L
Time frame: Baseline, 8 weeks and 12 months
Questionnaire - client service receipt inventory (CSRI)
Time frame: Baseline, 8 weeks and 12 months
Physical activity monitor (worn for 1 week) - total energy expenditure
Time frame: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test - ventilatory threshold (VT)
Time frame: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope)
Time frame: Baseline, 8 weeks and 12 months
Echocardiography - left ventricular volumes
Time frame: Baseline, 8 weeks and 12 months
Arterial oscillometry - pulse wave velocity
Time frame: Baseline, 8 weeks and 12 months
CHD risk factor assessment
Time frame: 8 weeks
Qualitative psychology - thematic analysis of semi structured interviews
University Hospitals Coventry and Warwickshire NHS Trust
Other
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
Acronym: HIIT-or-MISS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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