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Completed

NCT Number: NCT02784873

High Intensity Interval Training in UK Cardiac Rehabilitation Programmes

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Coventry, CV2 2DX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General inclusion criteria:

  • Successfully revascularised following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Angiographically documented non-obstructive coronary artery disease (CAD)
  • Left ventricular ejection fraction (LVEF) > 40%
  • Clinically stable (symptoms and medication) for > 2 weeks 5.18 - 75 yrs of age

General exclusion criteria:

  • Symptoms of ischemia
  • Significant left main stem stenosis
  • NYHA class III-IV symptoms
  • Compromising cardiac ventricular arrhythmia
  • Significant valvular heart disease
  • Inability to comply with guidelines for participation in exercise testing and training
  • 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:

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

Treatment and study plan

High Intensity Interval Training

Other

High intensity interval training within a standard cardiac rehabilitation programme

Primary outcomes

  1. Change in peak oxygen uptake (VO2 peak)

    Time frame: Baseline, 8 weeks and 12 months

    Cardiopulmonary exercise test

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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;

  6. HR-QOL

    Time frame: Baseline, 8 weeks and 12 months

    Questionnaire - EQ-5D-5L

  7. Service and resource use

    Time frame: Baseline, 8 weeks and 12 months

    Questionnaire - client service receipt inventory (CSRI)

  8. Lifestyle physical activity

    Time frame: Baseline, 8 weeks and 12 months

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

  9. Metabolic reserve

    Time frame: Baseline, 8 weeks and 12 months

    Cardiopulmonary exercise test - ventilatory threshold (VT)

  10. Ventilatory efficiency

    Time frame: Baseline, 8 weeks and 12 months

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

  11. Cardiac remodelling

    Time frame: Baseline, 8 weeks and 12 months

    Echocardiography - left ventricular volumes

  12. Arterial remodelling

    Time frame: Baseline, 8 weeks and 12 months

    Arterial oscillometry - pulse wave velocity

  13. Cardiovascular health

    Time frame: Baseline, 8 weeks and 12 months

    CHD risk factor assessment

  14. Palatability

    Time frame: 8 weeks

    Qualitative psychology - thematic analysis of semi structured interviews

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

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

Registry information

Official study 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

Acronym: HIIT-or-MISS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 27, 2016
Registry last updated
May 5, 2021

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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