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

被引:0
|
作者
Graby, John [1 ,2 ]
Khavandi, Ali [1 ]
Gillison, Fiona [2 ]
Smith, Theresa [3 ]
Murphy, David [1 ,2 ]
Peacock, Oliver [2 ]
Mcleod, Hugh [4 ]
Dastidar, Amardeep [5 ]
Antoniades, Charalambos [6 ]
Thompson, Dylan [2 ]
Rodrigues, Jonathan Carl Luis [2 ,7 ]
机构
[1] Royal United Hosp, Cardiol, Bath NHS Fdn Trust, Bath, England
[2] Univ Bath, Hlth, Bath, England
[3] Univ Bath, Math, Bath, England
[4] Univ Bristol, Bristol BS8 1TL, England
[5] North Bristol NHS Trust, Cardiol, Bristol, England
[6] Univ Oxford, John Radcliffe Hosp, Acute Multidisciplinary Imaging & Intervent Ctr, Oxford, England
[7] NHS Fdn Trust, Royal United Hosp Bath, Bath, England
来源
BMJ OPEN | 2023年 / 13卷 / 12期
基金
美国国家卫生研究院;
关键词
Coronary heart disease; Cardiovascular imaging; Adult cardiology; Rehabilitation medicine; METABOLIC SYNDROME; PHYSICAL-ACTIVITY; STATIN THERAPY; EXERCISE; IMPACT; RISK; ATHEROSCLEROSIS; INFLAMMATION; MARKERS; EVENTS;
D O I
10.1136/bmjopen-2023-080735
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IntroductionPatients 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.IntroductionPatients 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.IntroductionPatients 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 analysisThis 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 disseminationEthics 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 numberISRCTN14603929.
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页数:9
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