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PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial
INTRODUCTION: Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to a stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6530430/ https://www.ncbi.nlm.nih.gov/pubmed/31092666 http://dx.doi.org/10.1136/bmjopen-2018-027974 |
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author | Yau, Derek King Wai Wong, Man Kin Henry Wong, Wai-Tat Gin, Tony Underwood, Malcolm John Joynt, Gavin Mathew Lee, Anna |
author_facet | Yau, Derek King Wai Wong, Man Kin Henry Wong, Wai-Tat Gin, Tony Underwood, Malcolm John Joynt, Gavin Mathew Lee, Anna |
author_sort | Yau, Derek King Wai |
collection | PubMed |
description | INTRODUCTION: Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to a stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty are associated with poor patient outcomes and higher healthcare costs. The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared. METHOD AND ANALYSIS: A single-centre, superiority, stratified randomised controlled trial with a blinded outcome assessment and intention-to-treat analysis. Pre-frail and frail patients awaiting elective coronary artery bypass graft, with or without valvular repair/replacement, will be recruited. 164 participants will be randomly assigned to either prehabilitation (intervention) or standard care (no intervention) groups. The prehabilitation group will attend two sessions/week of structured exercise (aerobic and resistance) training, supervised by a physiotherapist, for 6–10 weeks before surgery with early health promotion advice in addition to standard care. The standard care group will receive the usual routine care (no prehabilitation). Frailty will be assessed at baseline, hospital admission and at 1 and 3 months after surgery. The primary outcomes will be participants' perceived quality of recovery (15-item Quality of Recovery questionnaire) after surgery (day 3), days at home within 30 days of surgery and the changes in WHO Disability Assessment Schedule 2.0 score between baseline and at 1 and 3 months after surgery. Secondary outcomes will include major adverse cardiac and cerebrovascular events, psychological distress levels, health-related quality of life and healthcare costs. ETHICS AND DISSEMINATION: The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2017.696 T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants. TRIAL REGISTRATION NUMBER: ChiCTR1800016098; Pre-results. |
format | Online Article Text |
id | pubmed-6530430 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-65304302019-06-07 PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial Yau, Derek King Wai Wong, Man Kin Henry Wong, Wai-Tat Gin, Tony Underwood, Malcolm John Joynt, Gavin Mathew Lee, Anna BMJ Open Anaesthesia INTRODUCTION: Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to a stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty are associated with poor patient outcomes and higher healthcare costs. The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared. METHOD AND ANALYSIS: A single-centre, superiority, stratified randomised controlled trial with a blinded outcome assessment and intention-to-treat analysis. Pre-frail and frail patients awaiting elective coronary artery bypass graft, with or without valvular repair/replacement, will be recruited. 164 participants will be randomly assigned to either prehabilitation (intervention) or standard care (no intervention) groups. The prehabilitation group will attend two sessions/week of structured exercise (aerobic and resistance) training, supervised by a physiotherapist, for 6–10 weeks before surgery with early health promotion advice in addition to standard care. The standard care group will receive the usual routine care (no prehabilitation). Frailty will be assessed at baseline, hospital admission and at 1 and 3 months after surgery. The primary outcomes will be participants' perceived quality of recovery (15-item Quality of Recovery questionnaire) after surgery (day 3), days at home within 30 days of surgery and the changes in WHO Disability Assessment Schedule 2.0 score between baseline and at 1 and 3 months after surgery. Secondary outcomes will include major adverse cardiac and cerebrovascular events, psychological distress levels, health-related quality of life and healthcare costs. ETHICS AND DISSEMINATION: The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2017.696 T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants. TRIAL REGISTRATION NUMBER: ChiCTR1800016098; Pre-results. BMJ Publishing Group 2019-05-14 /pmc/articles/PMC6530430/ /pubmed/31092666 http://dx.doi.org/10.1136/bmjopen-2018-027974 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Anaesthesia Yau, Derek King Wai Wong, Man Kin Henry Wong, Wai-Tat Gin, Tony Underwood, Malcolm John Joynt, Gavin Mathew Lee, Anna PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title | PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title_full | PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title_fullStr | PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title_full_unstemmed | PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title_short | PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial |
title_sort | prehabilitation for improving quality of recovery after elective cardiac surgery (prequel) study: protocol of a randomised controlled trial |
topic | Anaesthesia |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6530430/ https://www.ncbi.nlm.nih.gov/pubmed/31092666 http://dx.doi.org/10.1136/bmjopen-2018-027974 |
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