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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.

SUBMITTER: McIsaac DI

PROVIDER: S-EPMC6020976 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery.

McIsaac Daniel I DI Saunders Chelsey C Hladkowicz Emily E Bryson Gregory L GL Forster Alan J AJ Gagne Sylvain S Huang Allen A Lalu Manoj M Lavallee Luke T LT Moloo Husein H Nantel Julie J Power Barbara B Scheede-Bergdahl Celena C Taljaard Monica M van Walraven Carl C McCartney Colin J L CJL

BMJ open 20180622 6

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

PMID: 29934394

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Project description:ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

Project description:BackgroundFrailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD.MethodsParticipants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability.ResultsSix hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence.ConclusionsThis pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD.Trial registrationISRCTN87708989; https://clinicaltrials.gov/.

Project description:IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3-4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

Project description:BackgroundFast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery).Methods/designThis trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean ± standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score.DiscussionThe advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery.Trial registration numberNCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

Project description:BackgroundOlder people living with HIV (OPLWH) are expected to live longer in the era of antiretroviral treatment, but at the same time, they are at risk for developing various health complications as a consequence of a life with the infection, exposure to medications that carry their own toxicity and side effects, and the natural effects of aging on the immune system. Because senescence is an inherent process that can be accelerated by HIV, it is important to identify strategies that can modify this phenomenon. Emerging data suggests that while physical activity and exercise may not have a positive impact on viral replication and on the immune system of people living with HIV, it can elicit improvements in cardiorespiratory fitness, strength, body composition, and overall quality of life. The purpose of this study is to map out empirical evidence on the effects of physical activity and exercise in OPLWH.MethodsThe scoping review methods will be guided by the framework proposed by the Joanna Briggs Institute guidelines. Literature searches will be conducted in the following electronic databases (from inception onwards): PubMed/MEDLINE, Cochrane Library, and Google Scholar. Peer-reviewed journal papers will be included if they are written in English, involved human participants aged 50 years, and older with HIV and described a measure for physical, mental, or functional status of physical activity/exercise and/or the recommendations in OPLWH. Quantitative, qualitative, and mixed-method studies will be included in order to consider different aspects of measuring the effects of physical activity and exercise (e.g., quality of life, functional status, activities of daily living). Two reviewers will screen all citations and full-text articles. We will abstract data, organize them into themes and sub-themes, summarize them, and report the results using a narrative synthesis. The study methodological quality (or bias) will be appraised using a Mixed Methods Appraisal Tool.DiscussionThe evidence gathered from the selected studies will be discussed in relation to the research questions using a narrative to identify and explore emergent themes. The review will provide a baseline of evidence on exercise and physical activity interventions for OPLWH. It will highlight gaps regarding the use of exercise and physical activity and contribute to the design of an effective intervention approach to the rehabilitation of OPLWH.Systematic review registrationOpen Science Framework (https://osf.io/728kp/).

Project description:Preoperative functional capacity is considered an important risk factor for cardiovascular and other complications of major non-cardiac surgery. Nonetheless, the usual approach for estimating preoperative functional capacity, namely doctors' subjective assessment, may not accurately predict postoperative morbidity or mortality. 3 possible alternatives are cardiopulmonary exercise testing; the Duke Activity Status Index, a standardised questionnaire for estimating functional capacity; and the serum concentration of N-terminal pro-B-type natriuretic peptide (NT pro-BNP), a biomarker for heart failure and cardiac ischaemia.The Measurement of Exercise Tolerance before Surgery (METS) Study is a multicentre prospective cohort study of patients undergoing major elective non-cardiac surgery at 25 participating study sites in Australia, Canada, New Zealand and the UK. We aim to recruit 1723 participants. Prior to surgery, participants undergo symptom-limited cardiopulmonary exercise testing on a cycle ergometer, complete the Duke Activity Status Index questionnaire, undergo blood sampling to measure serum NT pro-BNP concentration and have their functional capacity subjectively assessed by their responsible doctors. Participants are followed for 1 year after surgery to assess vital status, postoperative complications and general health utilities. The primary outcome is all-cause death or non-fatal myocardial infarction within 30 days after surgery, and the secondary outcome is all-cause death within 1 year after surgery. Both receiver-operating-characteristic curve methods and risk reclassification table methods will be used to compare the prognostic accuracy of preoperative subjective assessment, peak oxygen consumption during cardiopulmonary exercise testing, Duke Activity Status Index scores and serum NT pro-BNP concentration.The METS Study has received research ethics board approval at all sites. Participant recruitment began in March 2013, and 1-year follow-up is expected to finish in 2016. Publication of the results of the METS Study is anticipated to occur in 2017.

Project description:BackgroundThere is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.MethodsA total of 80 BS patients [60-80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016).DiscussionThe present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria.Trial registrationThe trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.

Project description:IntroductionChronic cytomegalovirus (CMV) infection is very frequent in people living with HIV (PLWH). High anti-CMV IgG titres, which may be linked to transient CMV replication, have been associated with earlier mortality, CD8 T-cell expansion, lower CD4/CD8 ratio and increased T-cell senescence. We previously showed that anti-CMV IgG titres correlated with gut permeability in PLWH on antiretroviral therapy (ART), which was associated with microbial translocation, systemic inflammation and non-infectious/non-AIDS comorbidities. Letermovir, a novel anti-CMV drug with a good safety profile, was recently approved for anti-CMV prophylaxis in allogeneic haematopoietic stem cell transplant recipients. A drastic and selective reduction of both low-grade replication and clinically significant CMV infections, combined with an improved immune reconstitution have been reported. In vitro, letermovir prevented CMV-induced epithelial disruption in intestinal tissues. Based on these findings, we aim to assess whether letermovir could inhibit CMV subclinical replication in CMV-seropositive PLWH receiving ART and, in turn, decrease CMV-associated gut damage and inflammation.Method and analysisWe will conduct a multi-centre, open-label, randomised, controlled clinical trial, including a total of 60 CMV-seropositive ART-treated PLWH for at least 3 years, with a viral load <50 copies/mL and CD4+ count >400 cells/µL. Forty participants will be randomised to receive letermovir for 14 weeks and 20 participants will receive standard of care (ART) alone. Plasma, pheripheral blood mononuclear cells (PBMCs), and stool samples will be collected. Colon biopsies will be collected in an optional substudy. We will assess the effect of letermovir on gut damage, microbial translocation, inflammation and HIV reservoir size.Ethics and disseminationThe study was approved by Health Canada and the Research Ethics Boards of the McGill University Health Centre (MUHC-REB, protocol number: MP37-2022-8295). Results will be made available through publications in open access peer-reviewed journals and through the CIHR/CTN website.Trial registration numberNCT05362916.

Dataset Information

PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery.

Publications

PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery.

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