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The influence of high-intensity compared with moderate-intensity exercise training on the health of colorectal cancer survivors: a randomised controlled trial

ABSTRACT: Interventions: This project will investigate the feasibility and efficacy of high intensity exercise (HIE) as compared with moderate intensity exercise (MIE) on the insulin-like growth factor (IGF) axis, cardiorespiratory fitness, body composition and psychosocial health in colorectal cancer survivors. Study Design: This study is a three-arm, 12 week randomised controlled trial. Participants: Men and women who have been previously treated for colorectal cancer will be invited to participate in this randomised clinical trial. Intervention Structure: Following recruitment, participants will complete a familiarisation session, before which they will be provided with further details of the research program and afforded the opportunity to seek clarification for any questions related to the study. At the commencement of this session informed consent will be attained by way of a written consent form, witnessed by the principle investigator. The familiarisation session will conclude with a test of peak oxygen consumption (VO2peak test) After familiarisation, participants will complete a baseline testing session to measure all primary and secondary outcomes. Participants will then be randomised to one of three groups: (1) high intensity exercise - continuous (HIE-C) training group; (2) high intensity exercise - tapered (HIE-T) training group;(3) or a moderate intensity exercise (MIE) training group. The HIE-C and MIE groups will train at a frequency of 3 times per week for 8 weeks whereas the HIE-T group will train at a frequency of 3 times per week for the first 4 weeks, and at a frequency of once per week for the later 4 weeks. Participants will undergo testing at baseline (0 weeks), midpoint (4 weeks), endpoint (8 weeks) and follow-up (12 weeks). P Primary outcome(s): Insulin-like growth factor (IGF)-1, analysed using a commercially available plasma enzyme linked immunosorbent assay (ELISA) [Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)];IGF binding protein (IGFBP) - 3, analysed using a commercially available plasma ELISA[Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks) ];IGF-2, analysed using a commercially available plasma ELISA[Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Colorectal Cancer,Physical Medicine / Rehabilitation-other Physical Medicine / Rehabilitation,Cancer Survivorship,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2462586 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The study has been described in the following paper: Gianni Parise, Stuart M. Phillips, Jan J. Kaczor and Mark A. Tarnopolsky (2005). Antioxidant enzyme activity is up-regulated after unilateral resistance exercise training in older adults. Free Radical Biology and Medicine, Volume 39, Issue 2, 15 July 2005, Pages 289-295 We cite the following three paragraphs from this paper: "MATERIALS AND METHODS Subjects Twelve men (71.2 ± 6.5 y) volunteered to participate in a 12 week uni-lateral leg resistance training program (Table 1). All subjects underwent a thorough screening process before being admitted into the study. Subjects were first screened by telephone, and were then subject to a medical evaluation. Consent from their family physician was required, and then all potential subjects underwent a resting electrocardiogram, and a sub-maximal graded exercise test on a bicycle ergometer witih a 12-lead ECG. Exclusion criteria included: evidence of coronary hear disease; congestive heart failure; uncontrolled hypertension; chronic obstructive pulmonary disease; diabetes mellitus; renal failure; major orthopaedic disability; and smoking. None of the subjects had ever participated in a structured exercise program. After subjects were advised of the benefits and risks of participation, subjects gave their written informed consent. The study was approved by the McMaster University and Hamilton Health Sciences Research Ethics Board and conferred to the principles of the declaration of Helsinki. Exercise Training Resistance training was performed three times weekly on non-consecutive days (Monday, Wednesday, and Friday) for 12 weeks, under strict supervision. Prior to and after each training session subjects were required to perform passive stretching. Resistance exercise for each session consisted of 3 sets of 10 repetitions for each of leg press and leg extension. Training progressed from one set of each exercise at 50% of the initial 1 repetition maximum (1RM) to 3 sets at 80% of 1RM over the training period. Training logs were kept to record the volume and intensity of each session. The 1RM was re-evaluated every 2 weeks, and the training load was adjusted accordingly. All exercises were performed on universal strength training equipment (Universal Gym Equipment, Inc., Cedar Rapids, Iowa). Muscle Biopsy A muscle biopsy was taken from the vastus lateralis muscle of both legs before as well as after the training period, 20 cm proximal to the knee joint using a modified Bergström needle (5 mm diameter) with suction modification. The biopsy specimen was dissected of fat and connective tissue and immediately frozen in liquid nitrogen. All samples were stored at -80 °C for subsequent analysis. All subjects were required to abstain from strenuous physical activity for 48 hours prior to the testing session. The non-trained leg performed an acute bout of exercise at the same relative intensity of the training leg to allow for the determination of the effect of training and the effect of acute resistance exercise." Additional Notes: 1) The samples of 8 out 12 were used in the gene expression study. 2) The 2 factors in this study are: 2.1) Leg - Left or Right 2.2) Training - Baseline: samples taken on each leg before exercise - Resistance Training: one of the legs was subject to resistance training followed by acute exercise - Acute Exercise: the other leg had only the acute exercise 3) The baseline samples will be used for right versus left leg comparison to see variance between legs for human experimentation technical issues. The samples from Resistance or Acute Exercise will be compared to corresponding baseline samples to evaluate the effect of both exercise programs on gene expression.

Project description:Interventions: Men with prostate cancer receiving androgen deprivation therapy will attend three clinic-based supervised exercise sessions each week, for 12 weeks (3 months), consisting of moderate-to-high intensity resistance and aerobic exercise (interval and continuous). Each session will take approximately 60 minutes, including warm-up and cool-down, and will be supervised by accredited exercise physiologists (AEP; Exercise and Sport Science Australia, Brisbane, Australia), face-to-face (in groups of up to 8 people per session). The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention, thus will be tailored, progressive, periodised and autoregulated in collaboration with the patient (i.e. adjusted based on the patient’s presentation at each session). Resistance exercise will be prescribed using repetition maximums (RM), where patients will be required to perform 6-8 different resistance exercises using major muscle groups, at 6-12 RM (the maximal weight that can be lifted 6 to 12 times each set, equivalent to ~60-85% of 1RM) for 3-4 sets per exercise to achieve moderate-to-high intensity and volume. Aerobic exercise will include 20 to 30 minutes of moderate-to-vigorous intensity activity (equating to ~60-85% of estimated maximum heart rate; or a rating of perceived exertion (RPE) between 6-9 using the BORG-10 scale) involving a variety of modes including walking, jogging, cycling or rowing, using treadmills and/or stationary ergometers respectively. Aerobic intensity will be monitored using heart rate monitors (Polar M400, H10 Sensor, Polar Electro, NSW, Australia) and an RPE chart for assessment. Patients will also be encouraged to perform additional aerobic exercise Primary outcome(s): Microbiome Behaviour/DNA/Composition Gut Health and Function will be assessed through the provision of a 24-hour collection of stool sample(s); subsequently examined/analysed for microbiome behaviour/DNA/composition. The 24-hour collection of fecal samples will also be collected for comprehensive metabolomics analysis.[Week 0 (baseline) and Week 13 (post-intervention).];Fecal Calprotectin An analysis of fecal calprotectin analysis will be provided analysis also provided as an indicator of Gut Health and Function.[Week 0 (baseline) and Week 13 (post-intervention)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

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The influence of high-intensity compared with moderate-intensity exercise training on the health of colorectal cancer survivors: a randomised controlled trial

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