NCT02784873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

4.5 years

First QC Date

March 24, 2016

Last Update Submit

May 4, 2021

Conditions

Coronary Disease

Keywords

High intensity interval trainingCoronary heart diseaseExercise trainingCardiac rehabilitationInterval training

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen uptake (VO2 peak)

    Cardiopulmonary exercise test

    Baseline, 8 weeks and 12 months

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

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.

High intensity interval training

EXPERIMENTAL

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

Interventions

High intensity interval trainingOTHER

High intensity interval training within a standard cardiac rehabilitation programme

High intensity interval training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 22194152BACKGROUND

  • 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.

    PMID: 26375499BACKGROUND

  • 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.

    PMID: 25306500BACKGROUND

  • 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.

    PMID: 22879367BACKGROUND

  • Ingle L, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, Banerjee P, Shave R, McGregor G. Effects of Exercise Training Response on Quality of Life and Cardiovascular Risk Factor Profiles in People With Coronary Artery Disease: Insights From the HIIT or MISS UK Trial. Arch Phys Med Rehabil. 2024 Aug;105(8):1464-1470. doi: 10.1016/j.apmr.2024.03.002. Epub 2024 Mar 16.

    PMID: 38493909DERIVED

  • Albustami M, Hartfiel N, Charles JM, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, Hee SW, Banerjee P, Ingle L, Shave R, McGregor G, Edwards RT. Cost-effectiveness of High-Intensity Interval Training (HIIT) vs Moderate Intensity Steady-State (MISS) Training in UK Cardiac Rehabilitation. Arch Phys Med Rehabil. 2024 Apr;105(4):639-646. doi: 10.1016/j.apmr.2023.09.005. Epub 2023 Sep 18.

    PMID: 37730193DERIVED

  • McGregor G, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, McGuire S, Prosser J, Fiassam O, Hee SW, Hamborg T, Banerjee P, Hartfiel N, Charles JM, Edwards RT, Drane A, Ali D, Osman F, He H, Lachlan T, Haykowsky MJ, Ingle L, Shave R. High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):745-755. doi: 10.1093/eurjpc/zwad039.

    PMID: 36753063DERIVED

  • 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.

    PMID: 27852718DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karianne Backx, PhD

    Cardiff Metropolitan University

    PRINCIPAL INVESTIGATOR

  • Simon Nichols, PhD

    University of Hull

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

May 27, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 5, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)