{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2019"],"condition":["Cancer-Breast","Cancer-Prostate","Cancer-Bowel-Back passage (rectum) or large bowel (colon)","Colorectal Cancer","Prostate Cancer","Breast Cancer"],"disease":["Colorectal Cancer","Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)","Prostate Cancer","Cancer-prostate","Breast Cancer","Cancer-breast"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2468664"],"location":["Australia"],"study_start_month":["10"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"Preoperative exercise therapy for patients with cancer: A randomised-controlled trial","description":"Interventions: Phase 1 Randomised-controlled trial. Following the completion of written informed consent, participants will be stratified (by cancer type) and randomised (1:1) to one of two groups consisting of: a) the prehabilitation intervention group or b) usual care group.\nThe intervention will consist of a supervised exercise training session by an accredited exercise physiologist once every three days (estimated four weeks) up and until 3-5 days before surgery in a gym setting. If the scheduled date for surgery is > 4 weeks, or is delayed, participants will continue attending supervised exercise training sessions as per the protocol. Each exercise training session will commence and conclude with a 5-minute warm up and cool-down on a self-selected apparatus (treadmill; stationary bicycle; cross-trainer) and can be conducted in a group or individually. All training will be Aerobic and will be conducted predominantly on a cycle ergometer with additional aerobic exercises (e.g. treadmill, step-ups, cross-trainer) will also be used to maintain participant engagement with the program. The prescribed intensity will be set at 40-70% of HRR and/or a rating of perceived exertion of 11-16 (fairly light” to hard”; 6 – 20 scale). Exercise training sessions last between 45-60 minutes, which will aim to include approximately 30 minutes of dedicated aerobic training.\nThe Accredited Exercise Physiologist who is training the participants may make amendments to the training protocol on an individual basis. However, the exercise sessions will be delivered in a group setting based on particpants availbility. This will allow potential adjustments to the exercise type, intensity and volume during the session based on the patient’s perceived exertion. All amendments must be recorded.<br\nPrimary outcome(s): To examine the effectiveness of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal and breast cancer undergoing surgery in the Grampians region of Victoria. \nAssessed by number of adverse events and patient compliance. For example adverse clinical or laboratory findings, illness, or exacerbation/progression of disease/condition from the baseline assessment. All adverse events will be assessed by the prinicipal researcher present and a health professional present. An adverse event will be recorded on a AE/SAE report form and the PI responsible will present the AE to the HREC.\nThis is a composite outcome.\n[Post- exercise intervention completion (approximately 48 hrs pre-surgery), and at 30-days following surgery.];To examine the feasibility of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal and breast cancer undergoing surgery in the Grampians region of Victoria. The outcome of ventilatory threshold will be assessed through a metabolic cart.\nAssessed by changes in ventilatory threshold (VT) [Post- exercise intervention completion (approximately 48 hrs pre-surgery), and at 30-days following surgery.]\nStudy Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy","dates":{"creation":"2019-10-15"},"accession":"2468664","cross_references":{"Australian New Zealand Clinical Trials Registry":["ACTRN12619000214134"]}}