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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
Must not have
Not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks
Contraindications for cardiopulmonary stress and/or physical fitness tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is testing if supervised exercise can help bladder cancer patients who are receiving medication directly into their bladder. The study aims to see if exercise can improve their physical and mental well-being, manage side effects, and lower the chances of the cancer coming back.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bladder cancer is not muscle-invasive.
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I am scheduled for bladder treatment with chemo or immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not open to being assigned randomly to an exercise program or no exercise for 12 weeks.
Select...
I cannot undergo stress or fitness tests due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes of Peak Oxygen Consumption (VO2peak)
Secondary study objectives
Agility
Anthropometry and body composition measurements
Anxiety
+14 more
Other study objectives
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 more

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
913 Previous Clinical Trials
390,367 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

High-Intensity Interval Training Clinical Trial Eligibility Overview. Trial Name: NCT04593862 — Phase 2
Bladder Cancer Research Study Groups: Exercise Group, Usual Care:
Bladder Cancer Clinical Trial 2023: High-Intensity Interval Training Highlights & Side Effects. Trial Name: NCT04593862 — Phase 2
High-Intensity Interval Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04593862 — Phase 2
~18 spots leftby Sep 2025
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