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

High Intensity Interval Training in UK Cardiac Rehabilitation Programmes

Sponsors

Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Collaborator: Cardiff Metropolitan University
City Health Care Partnership CIC (Hull)
University of Hull
Aneurin Bevan University Health Board
Atrium Health
Bangor University
University of Warwick

Source 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.

Overall Status Recruiting
Start Date July 2016
Completion Date December 2020
Primary Completion Date March 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in peak oxygen uptake (VO2 peak) Baseline, 8 weeks and 12 months
Secondary Outcome
Measure Time Frame
Compliance and adherence Every exercise session (8 week exercise programme duration)
Psychological factors associated with compliance and adherence (1) Baseline, 8 weeks
Psychological factors associated with compliance and adherence (2) Baseline, 8 weeks
Psychological factors associated with compliance and adherence (3) Baseline, 8 weeks
Psychological factors associated with compliance and adherence (4) Baseline, 8 weeks
HR-QOL Baseline, 8 weeks and 12 months
Service and resource use Baseline, 8 weeks and 12 months
Lifestyle physical activity Baseline, 8 weeks and 12 months
Metabolic reserve Baseline, 8 weeks and 12 months
Ventilatory efficiency Baseline, 8 weeks and 12 months
Cardiac remodelling Baseline, 8 weeks and 12 months
Arterial remodelling Baseline, 8 weeks and 12 months
Cardiovascular health Baseline, 8 weeks and 12 months
Palatability 8 weeks
Enrollment 510
Condition
Intervention

Intervention type: Other

Intervention name: High intensity interval training

Description: High intensity interval training within a standard cardiac rehabilitation programme

Arm group label: High intensity interval training

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Gordon McGregor, PhD

Phone: 02476 234 570

Email: [email protected]

Location
facility status contact contact_backup University Hospital Gordon McGregor, PhD 02476 234 570 [email protected]
Location Countries

United Kingdom

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Usual care

Arm group type: No Intervention

Description: 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.

Arm group label: High intensity interval training

Arm group type: Experimental

Description: 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.

Acronym HIIT-or-MISS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov