High Intensity Interval Training in UK Cardiac Rehabilitation Programmes

Coronary Disease Clinical Trial

— HIIT-or-MISS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784873
• Other study ID #: GM164715
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2021

Study information

• Verified date: May 2021
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Other:
• High intensity interval training
High intensity interval training within a standard cardiac rehabilitation programme

Locations

Country	Name	City	State
United Kingdom	University Hospital	Coventry

Sponsors (8)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	Aneurin Bevan University Health Board, Atrium Health, Bangor University, Cardiff Metropolitan University, City Health Care Partnership CIC (Hull), University of Hull, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. Review. — View 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. Review. — View Citation

Rognmo Ø, Moholdt T, Bakken H, Hole T, Mølstad P, Myhr NE, Grimsmo J, Wisløff 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak oxygen uptake (VO2 peak)	Cardiopulmonary exercise test	Baseline, 8 weeks and 12 months
Secondary	Compliance and adherence	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)
Secondary	Psychological factors associated with compliance and adherence (1)	Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES)	Baseline, 8 weeks
Secondary	Psychological factors associated with compliance and adherence (2)	Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)	Baseline, 8 weeks
Secondary	Psychological factors associated with compliance and adherence (3)	Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES)	Baseline, 8 weeks
Secondary	Psychological factors associated with compliance and adherence (4)	Quantitative psychology - questionnaires: 4) Courneya and Bobick's 7-point bipolar adjectival rating scale;	Baseline, 8 weeks
Secondary	HR-QOL	Questionnaire - EQ-5D-5L	Baseline, 8 weeks and 12 months
Secondary	Service and resource use	Questionnaire - client service receipt inventory (CSRI)	Baseline, 8 weeks and 12 months
Secondary	Lifestyle physical activity	Physical activity monitor (worn for 1 week) - total energy expenditure	Baseline, 8 weeks and 12 months
Secondary	Metabolic reserve	Cardiopulmonary exercise test - ventilatory threshold (VT)	Baseline, 8 weeks and 12 months
Secondary	Ventilatory efficiency	Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope)	Baseline, 8 weeks and 12 months
Secondary	Cardiac remodelling	Echocardiography - left ventricular volumes	Baseline, 8 weeks and 12 months
Secondary	Arterial remodelling	Arterial oscillometry - pulse wave velocity	Baseline, 8 weeks and 12 months
Secondary	Cardiovascular health	CHD risk factor assessment	Baseline, 8 weeks and 12 months
Secondary	Palatability	Qualitative psychology - thematic analysis of semi structured interviews	8 weeks