Dataset Information

PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.

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 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.

SUBMITTER: Yau DKW

PROVIDER: S-EPMC6530430 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.

Yau Derek King Wai DKW Wong Man Kin Henry MKH Wong Wai-Tat WT Gin Tony T Gin Tony T Underwood Malcolm John MJ Joynt Gavin Mathew GM Lee Anna A

BMJ open 20190514 5

<h4>Introduction</h4>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 und ...[more]

PMID: 31092666

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Project description:BackgroundPrevious studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors.MethodsIn a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention.DiscussionIn this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients.Trial registrationGerman Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

Project description:Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis.Forty patients will be recruited and randomly allocated to one of the 2 treatment arms: 6 weeks supervised preoperative rehabilitation program (experimental group) or hospital standard preoperative management (control group). The intervention group will be trained three times per week, with each session aiming to improve strength, muscular endurance, spinal stabilization and cardiovascular fitness. Intensity and complexity of exercises will be gradually increased throughout the sessions, depending on each participant's individual progress. Primary outcomes are level of low back disability and level of pain. Secondary outcomes include the use of pain medication, quality of life, patient's global impression of change, lumbar extensor muscles endurance, maximum voluntary contraction of lumbar flexor and extensor muscles, maximum voluntary contraction of knee extensors, active lumbar ranges of motion, walking abilities, and cardiovascular capacity. Both the primary and secondary outcomes will be measured at baseline, at the end of the training program (6 weeks after baseline evaluation for control participants), and at 6 weeks, 3 and 6 months postoperatively.This study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical intervention. Results of this study will provide opportunity to efficiently improve spinal care and advance our knowledge of favorable preoperative strategies to optimize postoperative recovery.US National Institutes of Health Clinical Trials registry NCT02258672 , 10 February 2014.

Project description:IntroductionOlder patients undergoing cardiac surgery carry the highest risk for developing major postoperative neurocognitive disorder (postoperative NCD or P-NCD) with up to 25% incidence 3 months after surgery. P-NCD is associated with significant morbidity, mortality, loss of independence, premature retirement and increased healthcare costs. This multicentre randomised trial is investigating the efficacy of postoperative dexmedetomidine sedation in reducing the incidence of major P-NCD after cardiac surgery compared with standard protocols. CODEX will be the largest interventional trial with major P-NCD as the primary outcome.Methods and analysisCODEX is recruiting patients ≥60 years old, undergoing elective cardiac surgery and without pre-existing major cognitive dysfunction or dementia. Eligible participants are randomised to receive postoperative dexmedetomidine or standard institutional sedation protocols in the intensive care unit. Baseline preoperative cognitive function is assessed with the computer-based Cogstate Brief Battery. The primary outcome, major P-NCD, 3 months after surgery is defined as a decrease in cognitive function ≥1.96 SD below age-matched, non-operative controls. Secondary outcomes include delirium, major P-NCD at 6/12 months, depressive symptoms, mild P-NCD and quality of surgical recovery at 3/6/12 months. The specific diagnostic criteria used in this protocol are consistent with the recommendations for clinical assessment and management of NCD from the Nomenclature Consensus Working Group on perioperative cognitive changes. Intention-to-treat analysis will compare major P-NCD at 3 months between study groups.Ethics and disseminationCODEX was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB) (Project ID 1743). This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old. Dissemination of the study results will include briefings of key findings and interpretation, conference presentations and peer-reviewed publications.Trial registration numberNCT04289142.

Dataset Information

PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.

Introduction

Method and analysis

Ethics and dissemination

Trial registration number

Publications

PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.

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