Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol
Introduction Prehabilitation programmes that combine exercise training, nutritional support and emotional reinforcement (multimodal prehabilitation) have demonstrated efficacy reducing postoperative complications in the context of abdominal surgery. However, such programmes have seldom been studied...
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| Language: | English |
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BMJ Publishing Group
2020-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/12/e039885.full |
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| author | Miquel Coca-Martinez Antonio Lopez-Hernandez Mar Montane-Muntane Maria Jose Arguis Elena Gimeno-Santos Ricard Navarro-Ripoll Juan Perdomo Manuel Lopez-Baamonde Jose Rios Jorge Moises Maria Sanz de la Garza Elena Sandoval Barbara Romano Raquel Sebio Fernando Dana Graciela Martinez-Palli |
| author_facet | Miquel Coca-Martinez Antonio Lopez-Hernandez Mar Montane-Muntane Maria Jose Arguis Elena Gimeno-Santos Ricard Navarro-Ripoll Juan Perdomo Manuel Lopez-Baamonde Jose Rios Jorge Moises Maria Sanz de la Garza Elena Sandoval Barbara Romano Raquel Sebio Fernando Dana Graciela Martinez-Palli |
| author_sort | Miquel Coca-Martinez |
| collection | DOAJ |
| description | Introduction Prehabilitation programmes that combine exercise training, nutritional support and emotional reinforcement (multimodal prehabilitation) have demonstrated efficacy reducing postoperative complications in the context of abdominal surgery. However, such programmes have seldom been studied in cardiac surgery, one of the surgeries associated with higher postoperative morbidity and mortality. This trial will assess the feasibility and efficacy in terms of reduction of postoperative complications and cost-effectiveness of a multimodal prehabilitation programme comparing to the standard of care in cardiac surgical patients.Methods and analysis This is a single-centre, randomised, open-label, controlled trial with a 1:1 ratio. Consecutive 160 elective valve replacement and/or coronary revascularisation surgical patients will be randomised to either standard of care or 4–6 weeks of multimodal prehabilitation that will consist in (1) two times/week supervised endurance and strength exercise training sessions, (2) promotion of physical activity and healthy lifestyle, (3) respiratory physiotherapy, (4) nutrition counselling and supplementation if needed, and (5) weekly mindfulness sessions. Baseline, preoperative and 3-month postoperative data will be collected by an independent blinded evaluator. The primary outcome of this study will be the incidence of postoperative complications.Ethics and dissemination This study has been approved by the Ethics Committee of Clinical investigation of Hospital Clinic de Barcelona (HCB/2017/0708). The results will be disseminated in a peer-reviewed journal.Trial registration number NCT03466606. |
| format | Article |
| id | doaj-art-5bc80c970b544fa99d7ca4110f1bcc3f |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5bc80c970b544fa99d7ca4110f1bcc3f2025-08-20T02:23:23ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-039885Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocolMiquel Coca-Martinez0Antonio Lopez-Hernandez1Mar Montane-Muntane2Maria Jose Arguis3Elena Gimeno-Santos4Ricard Navarro-Ripoll5Juan Perdomo6Manuel Lopez-Baamonde7Jose Rios8Jorge Moises9Maria Sanz de la Garza10Elena Sandoval11Barbara Romano12Raquel Sebio13Fernando Dana14Graciela Martinez-Palli15Anaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain12 Respiratory Clinic Institute, Hospital Clinic of Barcelona, Barcelona, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainBiostatistics Unit, Universitat Autonoma de Barcelona Facultat de Medicina, Bellaterra, Catalunya, SpainRespiratory Medicine, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainCardiovascular Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, SpainDepartment of Cardiac Surgery, Cardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainNutrition and Clinical Dietetics, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain4 Department of Rehabilitation, Hospital Clinic de Barcelona, Barcelona, SpainPrehabilitation Unit, Hospital Clinic de Barcelona, Barcelona, Catalunya, SpainAnaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, SpainIntroduction Prehabilitation programmes that combine exercise training, nutritional support and emotional reinforcement (multimodal prehabilitation) have demonstrated efficacy reducing postoperative complications in the context of abdominal surgery. However, such programmes have seldom been studied in cardiac surgery, one of the surgeries associated with higher postoperative morbidity and mortality. This trial will assess the feasibility and efficacy in terms of reduction of postoperative complications and cost-effectiveness of a multimodal prehabilitation programme comparing to the standard of care in cardiac surgical patients.Methods and analysis This is a single-centre, randomised, open-label, controlled trial with a 1:1 ratio. Consecutive 160 elective valve replacement and/or coronary revascularisation surgical patients will be randomised to either standard of care or 4–6 weeks of multimodal prehabilitation that will consist in (1) two times/week supervised endurance and strength exercise training sessions, (2) promotion of physical activity and healthy lifestyle, (3) respiratory physiotherapy, (4) nutrition counselling and supplementation if needed, and (5) weekly mindfulness sessions. Baseline, preoperative and 3-month postoperative data will be collected by an independent blinded evaluator. The primary outcome of this study will be the incidence of postoperative complications.Ethics and dissemination This study has been approved by the Ethics Committee of Clinical investigation of Hospital Clinic de Barcelona (HCB/2017/0708). The results will be disseminated in a peer-reviewed journal.Trial registration number NCT03466606.https://bmjopen.bmj.com/content/10/12/e039885.full |
| spellingShingle | Miquel Coca-Martinez Antonio Lopez-Hernandez Mar Montane-Muntane Maria Jose Arguis Elena Gimeno-Santos Ricard Navarro-Ripoll Juan Perdomo Manuel Lopez-Baamonde Jose Rios Jorge Moises Maria Sanz de la Garza Elena Sandoval Barbara Romano Raquel Sebio Fernando Dana Graciela Martinez-Palli Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol BMJ Open |
| title | Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol |
| title_full | Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol |
| title_fullStr | Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol |
| title_full_unstemmed | Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol |
| title_short | Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol |
| title_sort | multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery a randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/10/12/e039885.full |
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