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An allied health rehabilitation program for patients following surgeryfor abdomino-pelvic cancer: a feasibility and pilot clinical study

ABSTRACT: Interventions: The general rehabilitation program will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks. The education component will include 1-hour nutritional advice and management provided by a dietitian; 1-hour exercise education regarding the importance of exercise to well-being, bladder and bowel advice, and adherence to exercise provided by a physiotherapist; 1-hour fatigue management and return to work strategies provided by an occupational therapist; and 5-hours health behavior change and self-management strategies provided by a psychologist. The exercise component will consist of a moderate intensity (Borg Rating of Perceived Exertion (RPE) Scale 12-14), physiotherapist-supervised, combined aerobic and resistance training program. The exercise program will be individualized based on the results from baseline outcome measures. Participants will be required to attend an one hour education session per week and an one hour exercise session per week over the 8-week intervention period. The home-based walking program requires participants to perform daily walking with duration and intensity individually prescribed based on the results of baseline walking tests. To encourage adherence to the home-based walking program, 6 telephone motivational coaching sessions (1 to 2 calls per month) will be provided from a physiotherapist, between data collection time-points 2 (immediately post-intervention) and 3 (6 months following baseline) . Daily feedback for participants regarding distance and number of steps taken will be encouraged with a simple pedometer. Primary outcome(s): Functional capacity as assessed using the six-minute walk test [At baseline, immediately post-intervention, and at 6 months following baseline];Feasibility as assessed by the recruitment rate, adherence, withdrawals, and adverse events. There are minimal risks associated with the rehabilitation and measurement tests. Participants may feel some general muscle discomfort after exercise, which is a normal response to exercise.[At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline] Study Design: Purpose: Educational / counselling / training; Allocation: Non-randomised trial

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

PROVIDER: 2460946 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Project description:Interventions: A specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with 6 months no-adjuvant androgen deprivation therapy and men NOT receiving (ADT) prior to beginning radiation therapy. Androgen Deprivation Therapy dose will be standardiesd to Lucrin ( leuprorelin) 22.5 mgs intramuscularly 3 monthly. The intervention will be delivered one on one with physiotherapist. The protocol will be tailored to men’s measured pelvic floor muscle function and adherence to the program will be encouraged using motivational interviewing principles. Men receiving radiation therapy alone will meet with physiotherapist for review at all follow-up points which are : immediately radiation therapy completed ,at 1 and 3 months after radiation therapy . Ongoing contact with the physiotherapist will be undertaken using men’s preferred method-text/phone/email. All men in the intervention group will receive a copy of the DVD - pelvic floor exercises for men that was produced by the chief investigator for the Prostate Cancer Foundation of Australia. Men receiving ADT will need to exercise for 6 months prior to their RT . These men will also have adherence encouraged as above. Exercises will be tailored to baseline so men on ADT will need to visit the physiotherapist fortnightly for reassessment and progression. Exercise will need to be performed 3 times daily but the number of repetition each time exercise is undertaken will be tailored to individually to suit the baseline function of men’s measured pelvic floor muscle function. The exercise sets will be the number of contractions that can be repeate Primary outcome(s): Lower urinary tract symptoms : incontinence, urgency, frequency, nocturia etcetera validated instrument ICSMLUTS SF Lower bowel symptoms evaluated using validated instrument ICSMLUTS Bowel[Baseline for all men: Immediately following radiation therapy 3 months following radiation therapy 6 months following radiation therapy Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy usually 6 months after beginning androgen deprivation therapy. Thereafter for all men: Immediately following radiation therapy 3 months after Radiation therapy 6 months after Radiation therapy];Erectile dysfunction using a validated instrument IIEFQuality of Life validated instrument MYMOP2[Baseline for all men Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy usually 6 months after beginning androgen deprivation therapy.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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: Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen du Primary outcome(s): Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion. [Post intervention program (12 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

Project description:Exercise has multi-systemic benefits and attenuates the physiological impairments associated with aging. Emerging evidence suggests that circulating exosomes mediate some of the beneficial effects of exercise via the transfer of microRNAs between tissues. However, the impact of regular exercise and acute exercise on circulating exosomal microRNAs (exomiRs) in older populations remains unknown. In the present study, we analyzed circulating exomiR expression in endurance-trained elderly men and age-matched sedentary males at baseline (Pre), immediately after a forty minute bout of aerobic exercise on a cycle ergometer (Post), and three hours after this acute exercise (3hPost). Plasma exosomes were isolated, characterized, and exomiR levels were determined by sequencing. The effect of regular exercise on circulating exomiRs was assessed using paired t-tests of baseline expression levels in the trained and sedentary groups. The effect of acute exercise was determined by comparing baseline and post-training expression levels in each group. Regular exercise resulted in significantly increased baseline expression of three exomiRs (miR-486-5p, miR-215-5p, miR-941) and decreased expression of one exomiR (miR-151b). Acute exercise altered circulating exomiR expression in both groups. However, exomiRs regulated by acute exercise in the trained group (7 miRNAs at Post and 8 at 3hPost) were distinct from those in the sedentary group (9 at Post and 4 at 3hPost). Pathway analysis prediction and reported target validation experiments revealed that the majority of exercise-regulated exomiRs are targeting genes that are related to IGF-1 signaling, a pathway involved in exercise-induced muscle and cardiac hypertrophy. The immediately post-acute exercise exomiR signature in the trained group correlates with activation of IGF-1 signaling, whereas in the sedentary group it is associated with inhibition of IGF-1 signaling. These results suggest that training status may counteract age-related anabolic resistance by modulating circulating exomiR profiles both at baseline and in response to acute exercise.

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An allied health rehabilitation program for patients following surgeryfor abdomino-pelvic cancer: a feasibility and pilot clinical study

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