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Preoperative exercise and education for patients undergoing major abdominal cancer surgery: A multicentre randomised controlled trial (PRIORITY Trial)

ABSTRACT: Interventions: The program will be delivered by trained clinicians in existing community facilities (e.g. physiotherapists or exercise physiologists close to participant home). We have deliberately chosen to position the study in a real world setting to ensure that the results will reflect what could be readily achieved in Australia and be more rapidly translated into clinical practice. Participants will be allocated to an individualised progressive preoperative exercise and education program (intervention group) or usual care alone (control group). All patients will undergo a baseline assessment prior to being randomised into either the preoperative exercise and education program (intervention) or usual care (control), and assessment week prior to surgery. The baseline and week before surgery assessments will collect subjective data with a self-reported questionnaire (measuring Duke Activity Status Index (DASI), Quality of life (SF-36v2), Physical Activity Questionnaire, Numerical Pain Rating Scale (NPRS) and Fatigue Severity Scale (FSS) and objective data with an assessment (includes a cardiorespiratory exercise test (CPET), a five times sit to stand test (5TSTS) and six minute walk test (6MWT)), for approximately one hour. Due to pandemic restrictions at the participating centres, the 5TSTS test will be performed by a trained clinician via video call in patients own home. The CPET and 6MWT assessments will be restricted and not uniformly assessed to all participants. Individualised preoperative exercise and education program (Intervention group) The main aim of the exercise program is to increase aerobic capacity and peripheral muscle endurance, muscle strength and respiratory muscle function and to educate participants to perform the exercise at home and about the surgi Primary outcome(s): The primary outcome will be the proportion of participants developing in-hospital complications within the primary admission of the index surgery. The primary outcome will be independently extracted from the hospital electronic medical records by two trial personnel blinded to group allocation. Disagreements will be resolved by discussion. Examples of potential in hospital complications include respiratory complications (e.g. pneumonia, lobar atelectasis, pleural fluid or respiratory failure), infectious complications (e.g. wound infection, surgical site infection or sepsis), cardiovascular complications (heart failure, acute myocardial infarction or deep venous thrombosis), renal complications (e.g. acute kidney injury or urinary retention), hepatic, pancreatic gastrointestinal complications (e.g. pancreatitis or gastrointestinal haemorrhage), surgical complication (e.g. anastomotic leak, urinary tract injury or mechanical bowel obstruction), neurological deficit or haematological complication, wound complication, or pain. [In hospital complication data will be extracted whilst each patient is admitted in hospital. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bowel-anal,Abdominal Cancers,Advanced Gastrointestinal Cancers,Cancer-pancreatic,Cancer-stomach,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Recurrent Gastrointestinal Cancers,Cancer-oesophageal (gullet),Cancer-liver

PROVIDER: 2472210 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Context: Exercise training is a plausible model for identification of molecular mechanisms that cause metabolic-related changes in human skeletal muscle. Objective: The goal was to explore the molecular basis of the adaptation of skeletal muscle to exercise training. Design and Intervention: Obese male subjects were subjected to an individualized supervised training program targeted in order to optimize lipid oxidation during 8 weeks. Main Outcome Measures: Primary outcome measures were gene expression profiling of skeletal muscle. Body composition, oral glucose tolerance test, Resting metabolic rate, respiratory quotient, maximal oxygen uptake and metabolic biochemistry were also assessed. Overall Design The obese (BMI 30-36) male volunteers (age 32-42) were asked to refrain from vigorous physical activity 48h before presenting to the clinical investigation centre, and ate a weight-maintaining diet consisting of 35% fat, 16% protein, and 49% carbohydrates two days before the experiment. Muscle biopsies of Vastus Lateralis weighing 60–100 mg were obtained using the Bergstrom technique, cleaned and snap-frozen in liquid nitrogen. Resting metabolic rate, respiratory quotient and maximal oxygen uptake were assessed. The subjects were investigated at baseline and after 8 weeks of supervised aerobic exercise training program consisting of daily sessions of 45-60 min of endurance exercise, 5 days a week, at least 48-72h after the last acute exercise bout. Skeletal muscle biopsies were obtained at the beginning and at the end of the protocol. Transcriptome analysis compared 8 subjects before vs. after training using arrays using a common reference design (Cy5 dye was incorporated into all muscle RNA samples, while a reference RNA pool made of the mix of commercial human liver, adipose tissue and skeletal muscle RNA was labelled with Cy3 dye (Applied Biosystems/Ambion, Foster City, USA)( and whole genome 4x44k oligonucleotide arrays (Agilent Technologies).

Project description:Interventions: Eligible participants will be prescribed an exercise program for a period of six weeks or up until surgery (whichever is earlier). Exercise prescriptions will be individualized to a participant’s prior aerobic fitness, medical comorbidities, response to any prior treatment and any immediate negative treatment effects of prior treatment (such as ongoing neuropathy and/or cancer cachexia) as per the ACSM Guidelines for exercise prescription. Exercise programs will be conducted one-on-one either in person in a hospital-based gym or unsupervised within the home environment based on the patient’s preference and ability to travel to the hospital. Exercise programs will be moderate to vigorous intensity as rated by the Borg RPE rating scale and prescribed in conjunction with cardiopulmonary exercise testing results. Exercise programs will include at least 3x30min aerobic exercise (walking/cycling/swimming) and 2x30min resistance sessions (upper and lower body strengthening exercises e.g. sit to stand, step ups, shoulder press) per week based on whether participants are meeting the ACSM exercise prescription guidelines at baseline. Participants will also be provided with a respiratory education session including information regarding breathing exercises to complete in the lead up to surgery. Given the complexity of this patient sample exercise prescription will also be adapted upon previous musculoskeletal injuries/issues (e.g. previous total joint replacements) and patients exercise preferences, to increase adherence with six-week program. Exercise programs will be progressed by a qualified physiotherapist and/or exercise physiologist based on participant’s response to exercise and compliance with the exercise program. The 30 min respiratory ed Primary outcome(s): Feasibility of delivering a six week individualized Exercise Prehabilitation Program amongst high risk surgical patients presenting for major cancer surgery. Feasibility of the program will be defined as: •Percentage of patients consenting to the exercise program = >70% consent rate •>70% adherence to exercise prescribed, as determined by participant exercise diaries •>85% retention in the study (Measures of non-compliance including dropout rates and reasons for drop out) •Intervention acceptability to patients •Cost of resources to run the study [Prior to surgery] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Type of endpoint: Safety/efficacy

Project description:Interventions: Participants will participate in an initial assessment conducted by a senior physiotherapist to determine baseline exercise tolerance and other descriptors. This includes a 6 minute walking test (6MWT) and a balance/frailty assessment called a short physical performance battery (SPPB). A quality of life survey (QLQ C30) will also be assessed at this time. They will then participate in a 2x weekly, one hour in length duration tailored supervised exercise program. This is conducted by a senior physiotherapist and 4th year physiotherapy students from Curtin University. Participants recruited may be currently receiving neoadjuvant chemoradiotherapy (CRT), have finished CRT on not completing CRT. The intervention is carried out despite their current CRT as to not impact on their cancer care. It has already been proven that exercise is safe at any point within the patients’ treatment journey and this is why this approach was taken. The program will consist of a walking program (determined from their 6MWT result) and resistance exercises via standard gymnasium equipment. The program is run as a group class, with a maximum of 10 participants per class. Their program will be documented and progressed / regressed as deemed appropriate by the supervising physiotherapist. The participants will be asked to exercise at a ‘moderate intensity’ which is described as ‘difficulty walking and talking’. The walking program is implemented on a flat walking track within the hospital, and resistance exercises are completed on standard gymnasium equipment in the Physiotherapy gym. These include, upper limb exercise with free weights, sit to stand, step ups, calf raises, body weight push up, large muscle group exercise on gym equipment (leg press, latissimus Primary outcome(s): Exercise tolerance in meters, assessed using 6-minute walk test (6MWT) [Following completion of a 6 week Prehabilitation exercise program compared to pre-completion of the program] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

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Preoperative exercise and education for patients undergoing major abdominal cancer surgery: A multicentre randomised controlled trial (PRIORITY Trial)

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