Clinical trial NCT02784873: High Intensity Interval Training in UK Cardiac Rehabilitation Programmes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: High intensity interval training
Coronary heart disease
Exercise training
Cardiac rehabilitation
Interval training
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: Cardiff Metropolitan University
name: City Health Care Partnership CIC (Hull)
name: University of Hull
name: Aneurin Bevan University Health Board
name: Wake Forest University Health Sciences
name: Bangor University
name: University of Warwick
First posted: 2016-05-27
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in peak oxygen uptake (VO2 peak)
timeFrame: Baseline, 8 weeks and 12 months
Secondary outcomes:
measure: Compliance and adherence
timeFrame: Every exercise session (8 week exercise programme duration)
measure: Psychological factors associated with compliance and adherence (1)
timeFrame: Baseline, 8 weeks
measure: Psychological factors associated with compliance and adherence (2)
timeFrame: Baseline, 8 weeks
measure: Psychological factors associated with compliance and adherence (3)
timeFrame: Baseline, 8 weeks
measure: Psychological factors associated with compliance and adherence (4)
timeFrame: Baseline, 8 weeks
measure: HR-QOL
timeFrame: Baseline, 8 weeks and 12 months
measure: Service and resource use
timeFrame: Baseline, 8 weeks and 12 months
measure: Lifestyle physical activity
timeFrame: Baseline, 8 weeks and 12 months
measure: Metabolic reserve
timeFrame: Baseline, 8 weeks and 12 months
measure: Ventilatory efficiency
timeFrame: Baseline, 8 weeks and 12 months
measure: Cardiac remodelling
timeFrame: Baseline, 8 weeks and 12 months
measure: Arterial remodelling
timeFrame: Baseline, 8 weeks and 12 months
measure: Cardiovascular health
timeFrame: Baseline, 8 weeks and 12 months
measure: Palatability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospital
Study officials:
affiliation: Cardiff Metropolitan University
name: Karianne Backx, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hull
name: Simon Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: West RR, Jones DA, Henderson AH. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction. Heart. 2012 Apr;98(8):637-44. doi: 10.1136/heartjnl-2011-300302. Epub 2011 Dec 22.
citation: Liou K, Ho S, Fildes J, Ooi SY. High Intensity Interval versus Moderate Intensity Continuous Training in Patients with Coronary Artery Disease: A Meta-analysis of Physiological and Clinical Parameters. Heart Lung Circ. 2016 Feb;25(2):166-74. doi: 10.1016/j.hlc.2015.06.828. Epub 2015 Jul 22.
citation: Elliott AD, Rajopadhyaya K, Bentley DJ, Beltrame JF, Aromataris EC. Interval training versus continuous exercise in patients with coronary artery disease: a meta-analysis. Heart Lung Circ. 2015 Feb;24(2):149-57. doi: 10.1016/j.hlc.2014.09.001. Epub 2014 Sep 16.
citation: Rognmo O, Moholdt T, Bakken H, Hole T, Molstad P, Myhr NE, Grimsmo J, Wisloff U. Cardiovascular risk of high- versus moderate-intensity aerobic exercise in coronary heart disease patients. Circulation. 2012 Sep 18;126(12):1436-40. doi: 10.1161/CIRCULATIONAHA.112.123117. Epub 2012 Aug 9.
citation: McGregor G, Nichols S, Hamborg T, Bryning L, Tudor-Edwards R, Markland D, Mercer J, Birkett S, Ennis S, Powell R, Begg B, Haykowsky MJ, Banerjee P, Ingle L, Shave R, Backx K. High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation. BMJ Open. 2016 Nov 16;6(11):e012843. doi: 10.1136/bmjopen-2016-012843.