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Exercise Medicine Prior to Open Radical Cystectomy in Adults with Bladder Cancer

Exercise Medicine Prior to Open Radical Cystectomy in Adults with Bladder Cancer: Feasibility and Preliminary Efficacy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000777897
Enrollment
20
Registered
2021-06-22
Start date
2018-05-23
Completion date
2021-03-30
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is investigating whether it is feasible to administer an exercise program prior to radical surgery for patients with bladder cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with bladder cancer, you will be undergoing radical open cystectomy and you have been invited to participate in the program by one of the investigating urologists who are based in Western Australia (Professor Hayne and Dr La Bianca). Participants who are not being treated in Western Australia will not be eligible for this study. Study details Participants who are invited to participate in this study will be prescribed an exercise program to be completed 2-3 times each week for a maximum of 4 weeks, dependent upon when their surgery has been scheduled, for cystectomy only and for those undergoing neo-adjuvant chemotherapy for approximately 12 weeks. Participants will undergo one-on-one training with an exercise physiologist for 2-3 one hour sessions each week, and will also be asked to complete another 20-30 minute exercise sessions (e.g. walking) on the other 2 days at home. The supervised sessions will involve two types of exercise, resistance training that may involve lifting weights or performing strength exercises, and aerobic training that may involve walking or jogging on a treadmill, cycling or rowing on a stationary machine. The exercise regime will finish prior to your scheduled surgery. You will be asked to complete a series of questionnaires before starting the exercise program, after completing the program, and 3 months after your surgery. It is hoped this research will demonstrate that a pre-surgical exercise program is safe and feasible to deliver to patients with bladder cancer, and that the exercise program may improve post-operative outcomes in these patients.

Interventions

Up to a 4-week supervised exercise program with a minimum of 2 weeks (based on scheduling for surgery) consisting of moderate- to high-intensity resistance- and aerobic-based training will be implemented for those having cystectomy only. For those undergoing chemotherapy prior to surgery, the exercise program will be for the duration of chemotherapy which is usually for about 12 weeks. Supervised training will be undertaken 3 times per week for approximately 1 hour each session with a home progr

Up to a 4-week supervised exercise program with a minimum of 2 weeks (based on scheduling for surgery) consisting of moderate- to high-intensity resistance- and aerobic-based training will be implemented for those having cystectomy only. For those undergoing chemotherapy prior to surgery, the exercise program will be for the duration of chemotherapy which is usually for about 12 weeks. Supervised training will be undertaken 3 times per week for approximately 1 hour each session with a home program of walking 2 or more days per week that consists of  20-30 minutes of activity. For those undergoing neo-adjuvant chemotherapy, supervised training sessions will be undertaken twice weekly. The sessions will be predominantly one-on-one with an accredited exercise physiologist (AEP) given that time to surgery and patient availability will determine timing of the training sessions. The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention. Resistance exercise will involve 6-8 exercises that target the major upper and lower body muscle groups, such as the chest  press, seated row, shoulder press, leg press, leg extension, leg curl, biceps curl and triceps extension. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the  maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-3 sets per exercise.  The aerobic exercise component will include ~20 minutes (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Sessions will  commence and conclude with a 5-minute warm-up and cool- down consisting of low level aerobic activities and stretching.  The training sessions will take place at the Vario Exercise Clinic in the Exercise Medicine Research Institute  (EMRI) at Edith Cowan University in Joondalup (north of Perth CBD) and at our new EMRI exercise clinic at Fiona Stanley Hospital (South of Perth CBD). Attendance will be noted based on attendance sheets and participant activity log.

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Twenty patients scheduled to undergo RC will be recruited by invitation from their attending Urologist (CI-Professor Hayne and CI-Dr La Bianca). Potential patients will be those with  muscle-invasive bladder cancer (greater than or equal to T2), patients with high-risk non-muscle-invasive bladder cancer (NMIBC) with atypical pathologic features (e.g., nested variant, micropapillary, etc.) or who prefer upfront cystectomy, those undertaking  salvage cystectomy after failed curative intent treatment with external beam radiation therapy (EBRT) and those undergoing chemotherapy prior to surgery.

Exclusion criteria

Exclusion criteria will include musculoskeletal, cardiovascular or neurological conditions that could inhibit patients from exercising.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026