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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 : September 27, 2019
Sponsor:
Collaborators:
Cardiff Metropolitan University
City Health Care Partnership CIC (Hull)
University of Hull
Aneurin Bevan University Health Board
Atrium Health
Bangor University
University of Warwick
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Disease Other: High intensity interval training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in peak oxygen uptake (VO2 peak) [ Time Frame: Baseline, 8 weeks and 12 months ]
    Cardiopulmonary exercise test


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Gordon McGregor, PhD 02476 234 570 gordon.mcgregor@uhcw.nhs.uk
Contact: Stuart Ennis, Msc 02476234 570 stuart.ennis@uhcw.nhs.uk

Locations
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United Kingdom
University Hospital Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Gordon McGregor, PhD    02476 234 570    gordon.mcgregor@uhcw.nhs.uk   
Contact: Stuart Ennis, MSc    02476 234 570    stuart.ennis@uhcw.nhs.uk   
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Cardiff Metropolitan University
City Health Care Partnership CIC (Hull)
University of Hull
Aneurin Bevan University Health Board
Atrium Health
Bangor University
University of Warwick
Investigators
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Principal Investigator: Karianne Backx, PhD Cardiff Metropolitan University
Principal Investigator: Simon Nichols, PhD University of Hull

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT02784873     History of Changes
Other Study ID Numbers: GM164715
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
High intensity interval training
Coronary heart disease
Exercise training
Cardiac rehabilitation
Interval training
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases