The BRAVE Study aims to test the safety and feasibility of an exercise intervention in bladder cancer patients who have been scheduled to receive or have completed at least one intravesical therapy. The BRAVE study also aims to:
(1) investigate the preliminary efficacy of exercise on health-related fitness (i.e. cardiorespiratory fitness and physical functioning) and patient-reported outcomes (i.e. quality of life, fear of cancer recurrence, anxiety, fatigue, perceived stress, and insomnia);
(2) examine the social cognitive predictors of exercise adherence (i.e., motivation, enjoyment, barriers);
(3) investigate the potential effects of exercise on tumor recurrence and progression.
Who is eligible for this study?
The study aims to include 66 patients diagnosed with non-muscle invasive bladder cancer and scheduled to receive or have completed at least one intravesical treatment (where the drug is placed directly in the bladder).
Eligible participants are those who are:
- scheduled to receive or have completed at least one intravesical treatment
- not currently exercising
Eligible patients will be contacted by the research team and informed about the study. Taking part in this study is voluntary. Once the patient decides to participate, the study coordinator will send the Consent Form, the baseline questionnaires, and book the baseline fitness assessment.
The study includes a questionnaire package to assess outcomes related to bladder cancer and its treatment, such as quality of life, fear of cancer recurrence and progression, anxiety, fatigue, perceived stress, insomnia, exercise motivation and barriers.
All participants will be asked to answer the questionnaires at baseline, 12-weeks later, and at one-year follow-up using e-mail or mail delivery format. The questionnaire package takes about 30-40 minutes to be completed.
Fitness assessment will include evaluation of cardiorespiratory fitness, which refers to the ability to perform dynamic exercise, involving large muscle groups, at a moderate to vigorous intensity for a prolonged time. Cardiorespiratory fitness will be assessed by a maximum exercise test performed on a treadmill. The aerobic exercise test can also be conducted in a cycle ergometer when a treadmill is not feasible (e.g. balance issues).
Fitness assessment will also include circumference measurements (waist, hip, and calf), body weight and height, and assessment of physical functioning (lower and upper body strength, lower and upper body flexibility, agility, and aerobic endurance).
Fitness assessments are about 90 minutes long and will be performed at baseline, 6-week, and at 12-week follow-up.
Assignment to a group
The patients willing to join the study will be assessed at baseline and randomly assigned to either the control group or exercise training group for 12 weeks.
There is no way to predict which group they will be assigned to. There is an equal chance of being placed in either group.
The reason why patients are assigned to different groups (usual care vs exercise) is to compare how they fare with their bladder cancer treatment. Any difference between groups at the end of the study (good or bad) can be more confidently attributed to the exercise intervention.
Patients randomized to the usual care group will be asked not to initiate any exercise program or to increase their exercise level from baseline during the 12-week study.
After the post-intervention assessments, patients in the usual care will be offered a 4-week supervised exercise program at the Behavioural Medicine Fitness Centre.
Exercise Training Group
The patients assigned to the exercise program will receive a 12-week supervised high-intensity aerobic exercise program on a treadmill or cycle ergometer.
High Intensity Interval Training (HIIT) can be described as short periods of vigorous-intensity exercise interspersed with light intensity exercise bouts for recovery.
The exercise prescription is personalized, defined based on the result of physical assessment, and will address different fitness levels of the participants. The sessions will be held three times per week for about one hour each.