High Intensity Interval Training in UK Cardiac Rehabilitation Programmes (HIIT-or-MISS)

May 4, 2021 updated by: University Hospitals Coventry and Warwickshire NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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:

  1. Exercise induced ischemia or significant hemodynamic compromise
  2. LVEF < 40%
  3. Clinical instability in accordance with CR guidelines
  4. Inability to comply with guidelines for participation in exercise testing and training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every exercise session (8 week exercise programme duration)
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)
Baseline, 8 weeks
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)
Baseline, 8 weeks
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)
Baseline, 8 weeks
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;
Baseline, 8 weeks
HR-QOL
Time Frame: Baseline, 8 weeks and 12 months
Questionnaire - EQ-5D-5L
Baseline, 8 weeks and 12 months
Service and resource use
Time Frame: Baseline, 8 weeks and 12 months
Questionnaire - client service receipt inventory (CSRI)
Baseline, 8 weeks and 12 months
Lifestyle physical activity
Time Frame: Baseline, 8 weeks and 12 months
Physical activity monitor (worn for 1 week) - total energy expenditure
Baseline, 8 weeks and 12 months
Metabolic reserve
Time Frame: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test - ventilatory threshold (VT)
Baseline, 8 weeks and 12 months
Ventilatory efficiency
Time Frame: Baseline, 8 weeks and 12 months
Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope)
Baseline, 8 weeks and 12 months
Cardiac remodelling
Time Frame: Baseline, 8 weeks and 12 months
Echocardiography - left ventricular volumes
Baseline, 8 weeks and 12 months
Arterial remodelling
Time Frame: Baseline, 8 weeks and 12 months
Arterial oscillometry - pulse wave velocity
Baseline, 8 weeks and 12 months
Cardiovascular health
Time Frame: Baseline, 8 weeks and 12 months
CHD risk factor assessment
Baseline, 8 weeks and 12 months
Palatability
Time Frame: 8 weeks
Qualitative psychology - thematic analysis of semi structured interviews
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborators

University of Hull
Wake Forest University Health Sciences
University of Warwick
Bangor University
Cardiff Metropolitan University
Aneurin Bevan University Health Board
City Health Care Partnership CIC (Hull)

Investigators

  • Principal Investigator: Karianne Backx, PhD, Cardiff Metropolitan University
  • Principal Investigator: Simon Nichols, PhD, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (ESTIMATE)

May 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM164715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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