PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery.
ABSTRACT: INTRODUCTION:Exercise prehabilitation may improve outcomes after surgery. Frailty is a key predictor of adverse postoperative outcomes in older people; the multidimensional nature of frailty makes this a population who may derive substantial benefit from exercise prehabilitation. The objective of this trial is to test the efficacy of exercise prehabilitation to improve postoperative functional outcomes for people living with frailty having cancer surgery with curative intent. METHODS AND ANALYSIS:We will conduct a single-centre, parallel-arm randomised controlled trial of home-based exercise prehabilitation versus standard care among consenting patients >60 years having elective cancer surgery (intra-abdominal and intrathoracic) and who are frail (Clinical Frailty Scale >4). The intervention consists of > 3 weeks of exercise prehabilitation (strength, aerobic and stretching). The primary outcome is the 6?min walk test at the first postoperative clinic visit. Secondary outcomes include the short physical performance battery, health-related quality of life, disability-free survival, complications and health resource utilisation. The primary outcome will be analysed by intention to treat using analysis of covariance. Outcomes up to 1?year after surgery will be ascertained through linkage to administrative data. ETHICS AND DISSEMINATION:Ethical approval has been granted by our ethics review board (Protocol Approval #2016009-01H). Results will be disseminated through presentation at scientific conferences, through peer-reviewed publication, stakeholder organisations and engagement of social and traditional media. TRIAL REGISTRATION NUMBER:NCT02934230; Pre-results.
Project 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.
Project description:<h4>Introduction</h4>In the past 20 years, the increasing burden of heart disease in an ageing population has resulted in cardiac surgery (CS) being offered to more frail and older patients with multiple comorbidities. Frailty and malnutrition are key geriatric syndromes that impact postoperative outcomes, including morbidity, mortality and prolonged hospital length of stay. Enhanced recovery protocols (ERPs), such as prehabilitation, have been associated with a reduction in complications after CS in vulnerable patients. The use of nutritional ERPs may enhance short-term and long-term recovery and mitigate frailty progression while improving patient-reported outcomes.<h4>Methods and analysis</h4>This trial is a two-centre, double-blinded, placebo, randomised controlled trial with blinded endpoint assessment and intention-to-treat analysis. One-hundred and fifty CS patients will be randomised to receive either a leucine-rich protein supplement or a placebo with no supplemented protein. Patients will consume their assigned supplement two times per day for approximately 2 weeks pre-procedure, during in-hospital postoperative recovery and for 8 weeks following discharge. The primary outcome will be the Short Physical Performance Battery score. Data collection will occur at four time points including baseline, in-hospital (pre-discharge), 2-month and 6-month time points post-surgery.<h4>Ethics and dissemination</h4>The University of Manitoba Biomedical Research Ethics Board (20 March 2018) and the St Boniface Hospital Research Review Committee (28 June 2019) approved the trial protocol for the primary site in Winnipeg, Manitoba, Canada. The second site's (Montreal, Quebec) ethics has been submitted and pending approval from the Research Ethics and New Technology Development Committee for the Montreal Heart Institute (December 2020). Recruitment for the primary site started February 2020 and the second site will begin January 2021. Data gathered from the PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery Study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share findings with stakeholders who are positioned to implement evidence-informed change.<h4>Potential study impact</h4>Malnutrition and frailty play a crucial role in post-CS recovery. Nutritional ERPs are increasingly being recognised as a clinically relevant aspect of perioperative care. As such, this trial is to determine if leucine-rich protein supplementation at key intervals can mitigate frailty progression and facilitate enhanced postoperative recovery.<h4>Trial registration number</h4>ClinicalTrials.gov Registry (NCT04038294).
Project description:INTRODUCTION:Prehabilitation interventions have shown efficacy in the orthopaedic and cardiothoracic surgical populations, but there has been limited evidence for general surgical patients. We present the protocol for a pilot trial of a novel prehabilitation intervention, consisting of a physiatrist-directed preoperative assessment and treatment programme. METHODS AND ANALYSIS:This is a single-centre pilot randomised controlled trial investigating physiatrist-directed prehabilitation for a 4 to 6-week preoperative period. We will block randomise 40-50 participants awaiting surgery for colorectal cancer to prehabilitation versus control. Participants in the prehabilitation arm will undergo assessment by a physiatrist and enrol in a supervised exercise programme. The control group will not undergo any prehabilitation interventions in the preoperative period. Our primary outcome is feasibility, measured by examining recruitment, refusal, retention and adherence rates as well as participant satisfaction and feedback. Secondary outcomes include physical fitness, functional ability, health-related quality of life, postoperative complications, mortality, readmissions, length of stay, prehabilitation interventions performed and exercise complications. ETHICS AND DISSEMINATION:This study has been approved by the Hamilton Integrated Research Ethics Board (HIREB reference number 2015-0090-GRA). The results of this pilot study will be used to design a full-scale study and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02531620; Pre-results.
Project description:<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>NCT03466606.
Project description:<h4>Importance</h4>Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.<h4>Objective</h4>To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.<h4>Design, setting, and participants</h4>This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n?=?290], unable to exercise [n?=?3], and planned neoadjuvant treatment [n?=?5]), and 120 frail patients (Fried Frailty Index,?2) were randomized. Ten patients were excluded after randomization because they refused surgery (n?=?3), died before surgery (n?=?3), had no cancer (n?=?1), had surgery without bowel resection (n?=?1), or were switched to palliative care (n?=?2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.<h4>Interventions</h4>Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.<h4>Main outcomes and measures</h4>The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.<h4>Results</h4>Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P?=?.45). Secondary outcome measures were also not different between groups.<h4>Conclusions and relevance</h4>In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.<h4>Trial registration</h4>ClinicalTrials.gov identifier: NCT02502760.
Project description:INTRODUCTION:Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. METHODS AND ANALYSIS:This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. ETHICS AND DISSEMINATION:This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. TRIAL REGISTRATION NUMBER:NCT02921932 (ClinicalTrials.gov).
Project description:BACKGROUND:Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer. METHODS:PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board. DISCUSSION:PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer. TRIAL REGISTRATION:ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).
Project description:INTRODUCTION:Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment. METHODS AND ANALYSIS:The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received. ETHICS AND DISSEMINATION:The study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT02780921.
Project description:BACKGROUND:Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly, targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery and, through evaluation of health economics, the impact of the programme on hospital costs. METHODS:The PRE-HIIT Randomised Controlled Trial (RCT) will compare a 2-week high intensity interval training (HIIT) programme to standard preoperative care in a cohort of thoracic and oesophageal patients who are >?2-weeks pre-surgery. A total of 78 participants will be recruited (39 per study arm). The primary outcome is cardiorespiratory fitness. Secondary outcomes include, measures of pulmonary and physical and quality of life. Outcomes will be measured at baseline (T0), and post-intervention (T1). Post-operative morbidity will also be captured. The impact of PRE-HIIT on well-being will be examined qualitatively with focus groups/interviews post-intervention (T1). Participant's experience of preparation for surgery on the PRE-HIIT trial will also be explored. The healthcare costs associated with the PRE-HITT programme, in particular acute hospital costs, will also be examined. DISCUSSION:The overall aim of this RCT is to examine the effect of tailored, individually prescribed high intensity interval training aerobic exercise on pre-operative fitness and postoperative recovery for patients undergoing complex surgical resections, and the impact on use of health services. TRIAL REGISTRATION:The study is registered with Clinical Trials.Gov (NCT03978325). Registered on 7th June 2019.
Project description:INTRODUCTION:Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery. METHODS:150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6?months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60?mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines. ANALYSIS:Demographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6?min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication. ETHICS AND DISSEMINATION:Ethics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal. TRIAL REGISTRATION NUMBER:Pre-results NCT03367728.