MedPath

High Intensity Interval Training in UK Cardiac Rehabilitation Programmes

Not Applicable
Completed
Conditions
Coronary Disease
Interventions
Other: High intensity interval training
Registration Number
NCT02784873
Lead Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
382
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High intensity interval trainingHigh intensity interval trainingHigh 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.
Primary Outcome Measures
NameTimeMethod
Change in peak oxygen uptake (VO2 peak)Baseline, 8 weeks and 12 months

Cardiopulmonary exercise test

Secondary Outcome Measures
NameTimeMethod
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;

Arterial remodellingBaseline, 8 weeks and 12 months

Arterial oscillometry - pulse wave velocity

Service and resource useBaseline, 8 weeks and 12 months

Questionnaire - client service receipt inventory (CSRI)

Compliance and adherenceEvery 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)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)

HR-QOLBaseline, 8 weeks and 12 months

Questionnaire - EQ-5D-5L

Metabolic reserveBaseline, 8 weeks and 12 months

Cardiopulmonary exercise test - ventilatory threshold (VT)

Cardiac remodellingBaseline, 8 weeks and 12 months

Echocardiography - left ventricular volumes

Palatability8 weeks

Qualitative psychology - thematic analysis of semi structured interviews

Lifestyle physical activityBaseline, 8 weeks and 12 months

Physical activity monitor (worn for 1 week) - total energy expenditure

Ventilatory efficiencyBaseline, 8 weeks and 12 months

Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope)

Cardiovascular healthBaseline, 8 weeks and 12 months

CHD risk factor assessment

Trial Locations

Locations (1)

University Hospital

🇬🇧

Coventry, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath