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Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris: study protocol for the PRO-FIT randomised controlled trial

Heutinck, JM, De Koning, IA, Vromen, T, Van Geuns, RJM, Thijssen, DHJ, Kemps, HMC, Adang, EM, Geleijnse, JM, van Gorp, P, van ‘t Hof, AWJ, Janssen, VR, Jorstad, HT, Kraaijenhagen, RA, Lammers, J, de Man, FHAF, Nollen, GJ, van Ofwegen-Hanekamp, CEE, Onkelinx, S, Oostveen, LMLC, Roes, KCB , Sunamara, M and Tonino, PAL (2023) Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris: study protocol for the PRO-FIT randomised controlled trial. BMC Cardiovascular Disorders, 23 (1). ISSN 1471-2261

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Abstract

Background: Currently, in the majority of patients with stable angina pectoris (SAP) treatment consists of optimal medical treatment, potentially followed by coronary angiography and subsequent coronary revascularisation if necessary”. Recent work questioned the effectiveness of these invasive procedures in reducing re-events and improving prognosis. The potential of exercise-based cardiac rehabilitation on clinical outcomes in patients with coronary artery disease is well-known. However, in the modern era, no studies compared the effects of cardiac rehabilitation versus coronary revascularisation in patients with SAP. Methods: In this multicentre randomised controlled trial, 216 patients with stable angina pectoris and residual anginal complaints under optimal medical treatment will be randomised to: 1) usual care (i.e., coronary revascularisation), or 2) a 12-month cardiac rehabilitation (CR) programme. CR consists of a multidisciplinary intervention, including education, exercise training, lifestyle coaching and a dietary intervention with a stepped decline in supervision. The primary outcome will be anginal complaints (Seattle Angina Questionnaire-7) following the 12-month intervention. Secondary outcomes include cost-effectiveness, ischemic threshold during exercise, cardiovascular events, exercise capacity, quality of life and psychosocial wellbeing. Discussion: In this study, we will examine the hypothesis that multidisciplinary CR is at least equally effective in reducing anginal complaints as the contemporary invasive approach at 12-months follow-up for patients with SAP. If proven successful, this study will have significant impact on the treatment of patients with SAP as multidisciplinary CR is a less invasive and potentially less costly and better sustainable treatment than coronary revascularisations. Trial registration: Netherlands Trial Register, NL9537. Registered 14 June 2021.

Item Type: Article
Uncontrolled Keywords: PRO-FIT Research Group; Humans; Treatment Outcome; Exercise; Quality of Life; Coronary Artery Disease; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Angina, Stable; Cardiac Rehabilitation; Cardiac rehabilitation; Chronic coronary syndrome; Coronary artery disease; Coronary revascularisation; Cost-effectiveness; Percutaneous coronary intervention; Stable angina pectoris; Humans; Cardiac Rehabilitation; Angina, Stable; Quality of Life; Coronary Artery Disease; Exercise; Treatment Outcome; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; 1102 Cardiorespiratory Medicine and Haematology; Cardiovascular System & Hematology
Subjects: Q Science > QP Physiology
R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions: Sport & Exercise Sciences
Publisher: Springer Science and Business Media LLC
SWORD Depositor: A Symplectic
Date Deposited: 21 Jul 2023 11:02
Last Modified: 21 Jul 2023 11:15
DOI or ID number: 10.1186/s12872-023-03266-z
URI: https://researchonline.ljmu.ac.uk/id/eprint/20472
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