High Intensity Interval Training in UK Cardiac Rehabilitation Programmes (HIIT-or-MISS)
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|ClinicalTrials.gov Identifier: NCT02784873|
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Other: High intensity interval training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||510 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Usual care
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
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
High intensity interval training within a standard cardiac rehabilitation programme
- Change in peak oxygen uptake (VO2 peak) [ Time Frame: Baseline, 8 weeks and 12 months ]Cardiopulmonary exercise test
- Compliance and adherence [ 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.
- Psychological factors associated with compliance and adherence (1) [ Time Frame: Baseline, 8 weeks ]Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES)
- Psychological factors associated with compliance and adherence (2) [ Time Frame: Baseline, 8 weeks ]Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
- Psychological factors associated with compliance and adherence (3) [ Time Frame: Baseline, 8 weeks ]Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES)
- Psychological factors associated with compliance and adherence (4) [ Time Frame: Baseline, 8 weeks ]Quantitative psychology - questionnaires: 4) Courneya and Bobick's 7-point bipolar adjectival rating scale;
- HR-QOL [ Time Frame: Baseline, 8 weeks and 12 months ]Questionnaire - EQ-5D-5L
- Service and resource use [ Time Frame: Baseline, 8 weeks and 12 months ]Questionnaire - client service receipt inventory (CSRI)
- Lifestyle physical activity [ Time Frame: Baseline, 8 weeks and 12 months ]Physical activity monitor (worn for 1 week) - total energy expenditure
- Metabolic reserve [ Time Frame: Baseline, 8 weeks and 12 months ]Cardiopulmonary exercise test - ventilatory threshold (VT)
- Ventilatory efficiency [ Time Frame: Baseline, 8 weeks and 12 months ]Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope)
- Cardiac remodelling [ Time Frame: Baseline, 8 weeks and 12 months ]Echocardiography - left ventricular volumes
- Arterial remodelling [ Time Frame: Baseline, 8 weeks and 12 months ]Arterial oscillometry - pulse wave velocity
- Cardiovascular health [ Time Frame: Baseline, 8 weeks and 12 months ]CHD risk factor assessment
- Palatability [ Time Frame: 8 weeks ]Qualitative psychology - thematic analysis of semi structured interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784873
|Contact: Gordon McGregor, PhD||02476 234 firstname.lastname@example.org|
|Contact: Stuart Ennis, Msc||02476234 email@example.com|
|Coventry, United Kingdom, CV2 2DX|
|Contact: Gordon McGregor, PhD 02476 234 570 firstname.lastname@example.org|
|Contact: Stuart Ennis, MSc 02476 234 570 email@example.com|
|Principal Investigator:||Karianne Backx, PhD||Cardiff Metropolitan University|
|Principal Investigator:||Simon Nichols, PhD||University of Hull|