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
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 invasi...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | BMC Cardiovascular Disorders |
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| Online Access: | https://doi.org/10.1186/s12872-023-03266-z |
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| author | Joyce M. Heutinck Iris A. De Koning Tom Vromen Robert-Jan M. Van Geuns Dick H.J. Thijssen Hareld M.C. Kemps On behalf of the PRO-FIT Research Group |
| author_facet | Joyce M. Heutinck Iris A. De Koning Tom Vromen Robert-Jan M. Van Geuns Dick H.J. Thijssen Hareld M.C. Kemps On behalf of the PRO-FIT Research Group |
| author_sort | Joyce M. Heutinck |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T14:05:56Z |
| format | Article |
| id | doaj.art-d6b64db6d8b74720820df0a5904ef2d3 |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-04-09T14:05:56Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-d6b64db6d8b74720820df0a5904ef2d32023-05-07T11:04:48ZengBMCBMC Cardiovascular Disorders1471-22612023-05-0123111310.1186/s12872-023-03266-zImpact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris: study protocol for the PRO-FIT randomised controlled trialJoyce M. Heutinck0Iris A. De Koning1Tom Vromen2Robert-Jan M. Van Geuns3Dick H.J. Thijssen4Hareld M.C. Kemps5On behalf of the PRO-FIT Research GroupDepartment of Industrial Design, Eindhoven University of TechnologyDepartment of Medical BioSciences, Radboud University Medical CentreDepartment of Cardiology, Maxima Medical CentreDepartment of Cardiology, Radboud University Medical CentreDepartment of Medical BioSciences, Radboud University Medical CentreDepartment of Industrial Design, Eindhoven University of TechnologyAbstract 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.https://doi.org/10.1186/s12872-023-03266-zCoronary artery diseaseCardiac rehabilitationCoronary revascularisationStable angina pectorisChronic coronary syndromePercutaneous coronary intervention |
| spellingShingle | Joyce M. Heutinck Iris A. De Koning Tom Vromen Robert-Jan M. Van Geuns Dick H.J. Thijssen Hareld M.C. Kemps On behalf of the PRO-FIT Research Group 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 Coronary artery disease Cardiac rehabilitation Coronary revascularisation Stable angina pectoris Chronic coronary syndrome Percutaneous coronary intervention |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Coronary artery disease Cardiac rehabilitation Coronary revascularisation Stable angina pectoris Chronic coronary syndrome Percutaneous coronary intervention |
| url | https://doi.org/10.1186/s12872-023-03266-z |
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