'Super Rehab': Can we achieve coronary artery disease regression? A feasibility study protocol

John Graby; Ali Khavandi; Fiona Gillison; Theresa Smith; David Murphy; Oliver Peacock; Hugh McLeod; Amardeep Dastidar; Charalambos Antoniades; Dylan Thompson; Jonathan Carl Luis Rodrigues

doi:10.1136/bmjopen-2023-080735

'Super Rehab': Can we achieve coronary artery disease regression? A feasibility study protocol

John Graby, Ali Khavandi, Fiona Gillison, Theresa Smith, David Murphy, Oliver Peacock, Hugh McLeod, Amardeep Dastidar, Charalambos Antoniades, Dylan Thompson, Jonathan Carl Luis Rodrigues

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management. Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression. This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting.

Methods and analysis: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT.

Ethics and dissemination: Ethics approval was granted by South West - Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications.

Trial registration number ISRCTN14603929.

Original language	English
Article number	e080735
Journal	BMJ Open
Volume	13
Issue number	12
Early online date	12 Dec 2023
DOIs	https://doi.org/10.1136/bmjopen-2023-080735
Publication status	Published - 12 Dec 2023

Funding

Royal United Hospitals Bath NHS Foundation Trust are the sponsors on behalf of the funder, who is the NIHR as stated below. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR202811). Further funding was provided by the sponsor's hospital charity, RUHX.

Funders	Funder number
Oxleas NHS Foundation Trust
National Institute for Health and Care Research
Research for Patient Benefit Programme	NIHR202811
Research for Patient Benefit Programme

Keywords

Adult cardiology
Cardiovascular imaging
Coronary heart disease
Rehabilitation medicine

ASJC Scopus subject areas

General Medicine

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10.1136/bmjopen-2023-080735Licence: CC BY

Cite this

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title = "'Super Rehab': Can we achieve coronary artery disease regression? A feasibility study protocol",

abstract = "Introduction: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management. Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression. This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting. Methods and analysis: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT. Ethics and dissemination: Ethics approval was granted by South West - Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. Trial registration number ISRCTN14603929.",

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author = "John Graby and Ali Khavandi and Fiona Gillison and Theresa Smith and David Murphy and Oliver Peacock and Hugh McLeod and Amardeep Dastidar and Charalambos Antoniades and Dylan Thompson and Rodrigues, {Jonathan Carl Luis}",

year = "2023",

month = dec,

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doi = "10.1136/bmjopen-2023-080735",

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T2 - Can we achieve coronary artery disease regression? A feasibility study protocol

AU - Graby, John

AU - Khavandi, Ali

AU - Gillison, Fiona

AU - Smith, Theresa

AU - Murphy, David

AU - Peacock, Oliver

AU - McLeod, Hugh

AU - Dastidar, Amardeep

AU - Antoniades, Charalambos

AU - Thompson, Dylan

AU - Rodrigues, Jonathan Carl Luis

PY - 2023/12/12

Y1 - 2023/12/12

N2 - Introduction: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management. Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression. This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting. Methods and analysis: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT. Ethics and dissemination: Ethics approval was granted by South West - Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. Trial registration number ISRCTN14603929.

AB - Introduction: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management. Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression. This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting. Methods and analysis: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT. Ethics and dissemination: Ethics approval was granted by South West - Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. Trial registration number ISRCTN14603929.

KW - Adult cardiology

KW - Cardiovascular imaging

KW - Coronary heart disease

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SN - 2044-6055

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JO - BMJ Open

JF - BMJ Open

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M1 - e080735

ER -

'Super Rehab': Can we achieve coronary artery disease regression? A feasibility study protocol

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Keywords

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