PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.
BMJ Open
; 9(5): e027974, 2019 05 14.
Article
em En
| MEDLINE
| ID: mdl-31092666
ABSTRACT
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 ANDANALYSIS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Temas:
Promover_ampliacao_atencao_especializada
Base de dados:
MEDLINE
Assunto principal:
Complicações Pós-Operatórias
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Cuidados Pré-Operatórios
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Procedimentos Cirúrgicos Eletivos
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Terapia por Exercício
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Fragilidade
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Procedimentos Cirúrgicos Cardíacos
Tipo de estudo:
Clinical_trials
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Guideline
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Qualitative_research
Aspecto:
Ethics
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Patient_preference
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2019
Tipo de documento:
Article