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Exercise Training for Bladder Cancer (BRAVE Trial)
Phase 2
Recruiting
Led By Kerry S Courneya
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of non-muscle invasive bladder cancer (clinical stage cis, Ta or T1)
Scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
BRAVE Trial Summary
This trial will test if it's safe and possible for bladder cancer patients to exercise while receiving drugs placed in their bladder. The investigators will compare the 2 groups on how they fare with their bladder cancer treatment.
Who is the study for?
This trial is for men and women over 18 with non-muscle invasive bladder cancer, scheduled for chemotherapy or immunotherapy. Participants must understand English and be medically cleared to exercise. Those already following a regular exercise routine or unwilling to be assigned randomly to an exercise program are excluded.Check my eligibility
What is being tested?
The BRAVE Trial is testing the safety and effectiveness of high-intensity interval training during intravesical therapy for bladder cancer patients. It will compare outcomes between those who participate in supervised exercise programs and those who do not during their treatment.See study design
What are the potential side effects?
While specific side effects aren't listed, exercising can sometimes lead to muscle soreness, fatigue, or injury if not done correctly. The study aims to ensure that high-intensity workouts are safe alongside bladder cancer treatments.
BRAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is not muscle-invasive.
Select...
I am scheduled for bladder treatment with chemo or immunotherapy.
BRAVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes of Peak Oxygen Consumption (VO2peak)
Secondary outcome measures
Agility
Anthropometry and body composition measurements
Anxiety
+14 moreOther outcome measures
Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval
Complete response
Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval
+5 moreBRAVE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise GroupExperimental Treatment1 Intervention
The exercise intervention will consist of 36 high-volume high-intensity interval sessions over a 12-week period. The exercise frequency will be three times per week during the 6 weeks of intravesical therapy and the 6 weeks of recovery (total 12 weeks) prior to a surveillance cystoscopy.
Group II: Usual Care:Active Control1 Intervention
Patients randomized to the control 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 and 3-month cystoscopy, patients in the control group will be offered a 4-week supervised exercise program at the Behavioural Medicine Fitness Centre, University of Alberta.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
891 Previous Clinical Trials
385,483 Total Patients Enrolled
Northern Alberta Urology CentreUNKNOWN
1 Previous Clinical Trials
2,800 Total Patients Enrolled
Cross Cancer InstituteOTHER
61 Previous Clinical Trials
19,124 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder cancer is not muscle-invasive.I am not open to being assigned randomly to an exercise program or no exercise for 12 weeks.You are already following a specific exercise routine based on the Godin Leisure-Time Exercise Questionnaire (GLTEQ).I am scheduled for bladder treatment with chemo or immunotherapy.I cannot undergo stress or fitness tests due to health reasons.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
- Group 2: Usual Care:
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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