- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593862
Bladder Cancer and exeRcise Training During intraVesical thErapy (BRAVE)
Feasibility and Preliminary Efficacy of High-Intensity Interval Training in Bladder Cancer Patients Receiving Intravesical Therapy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Fernanda Z Arthuso
- Phone Number: 7804922829
- Email: arthuso@ualberta.ca
Study Locations
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Alberta
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Edmonton, Alberta, Canada
- Recruiting
- Fernanda Zane Arthuso
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Contact:
- Fernanda Z Arthuso
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eligible participants will include men and women that (1) are ≥ 18 years old, (2) have a confirmed diagnosis of non-muscle invasive bladder cancer (clinical stage cis, Ta or T1), and (3) are scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents.
Exclusion Criteria:
- Exclusion criteria for participants include: (1) not being medically cleared to participate in the exercise intervention by their treating urologist and a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), (2) having contraindications for cardiopulmonary stress and/or physical fitness tests, (3) already exercising according to the Godin Leisure-Time Exercise Questionnaire (GLTEQ), (4) not having the ability to read and comprehend English, and (5) not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Exercise Group
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.
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The intervention will be performed on a treadmill and will include a warm-up and cool-down at 50-60% and 40% of the VO2peak respectively, for up to five minutes.
The HIIT protocol will be 4x4, which consists of four bouts of four minutes at a workload corresponding to vigorous intensity (75-95% of the baseline and 6-week VO2peak) alternating with three minutes of recovery intervals at 40% of the VO2peak.
The exercise session will last 35 minutes and include 16 minutes of high intensity exercise.
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No Intervention: Usual Care:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Peak Oxygen Consumption (VO2peak)
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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VO2 peak will be directly measured by the modified Bruce treadmill protocol exercise test, using a metabolic measurement system system (Parvo Medics TrueOne® 2400; Sandy, UT, USA).VO2peak will be defined as the highest oxygen-uptake value recorded during the test and will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).
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At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower body strength
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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30-second chair stand Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Upper body strength
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Arm curl Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Lower body Flexibility
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Chair sit-and-reach Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Upper body Flexibility
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Back Scratch Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Agility
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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8-foot up-and-go Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Functional Capacity
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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6-minute walk test Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average |
At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Anthropometry and body composition measurements
Time Frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Height, weight, waist, hip, and calf circumference
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At baseline, after the intravesical therapy (6-week), and 3-month follow-up
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Health-related quality of life (HRQoL)
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Assessment of health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30) version 3.0. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Bladder Cancer-Specific Quality of Life
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for non-muscle invasive bladder cancer core 24-item (EORTC QLQ NMIBC C24). EORTC QLQ NMIBC C24 is composed of scales assessing urinary symptoms, bowel symptoms, sexual, and side effects of intravesical treatment (fever, malaise, convenience of and worry due to repeated cystoscopies). All of the scales a range in score from 0 to 100. A high scale score represents a higher response level. |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Fear of cancer recurrence/progression
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Fear of cancer recurrence/progression will be assessed by the Fear of Cancer Recurrence Inventory Minimum: 0 Maximum:168 Higher score= higher levels of fear of cancer recurrence/progression |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Anxiety
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Anxiety will be assessed using the 10-item State-trait Anxiety Inventory. Minimum: 20 Maximum: 80 Higher score= worse anxiety |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Depression
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire. Minimum: 0 Maximum: 30 (cut off point: 10) Higher score= worse depression |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Perceived Stress
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire. questionnaire. Minimum: 0 Maximum: 56 Higher score=worse perceived stress |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Fatigue
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire Minimum: 0 Maximum: 52 Higher score=worse fatigue |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Self-esteem
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Self-esteem using the Rosenberg self-esteem scale Minimum: 10 Maximum: 40 Higher score= better self-esteem |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Sleep quality
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Sleep quality will be assessed by the Insomnia Severity Index (ISI) Minimum: 0 Maximum: 28 Higher score= worse insomnia |
At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Social cognitive predictors of exercise adherence: motivation, perceived benefits, enjoyment, support from others, self-efficacy, and barriers
Time Frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Standard scales for the Theory of Planned Behaviour
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At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Complete response
Time Frame: 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up
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Negative cytology, imaging, and cystoscopy and, when the TURBT is indicated, a negative biopsy.
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3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up
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Intravesical therapy adherence
Time Frame: 6-week follow-up
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Intravesical therapy adherence will be tracked by medical records of attendance and self-report drug retention time
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6-week follow-up
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Treatment toxicities
Time Frame: 6-week follow-up
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Treatment toxicities will be abstracted from medical records
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6-week follow-up
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Incidence of Adverse events related to the High-Intensity Interval Training during Intravesical Therapy
Time Frame: Through study completion, an average of 1 year
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To evaluate the safety of the program, any adverse events during the physical assessments (baseline, post- intravesical therapy, and post-intervention) and during the exercise sessions will be recorded.
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Through study completion, an average of 1 year
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Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval
Time Frame: At baseline
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The eligibility rate will be the number of non-muscle invasive bladder cancer patients
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At baseline
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Recruitment rate of non-muscle invasive bladder cancer patients to a high-intensity interval training during Intravesical Therapy
Time Frame: At baseline
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The recruitment rate will be the number of non-muscle invasive bladder cancer patients enrolled in the study divided by the number of eligible patients.
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At baseline
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Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval
Time Frame: Through exercise intervention completion, an average of 12-weeks
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Adherence to the program will be measured by the number of exercise sessions completed without dose modifications.
Reasons for not completing the exercise session or for dose adjustments will be recorded.
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Through exercise intervention completion, an average of 12-weeks
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Follow-up assessment rate of non-muscle invasive bladder cancer patients to a high-intensity interval program during Intravesical Therapy
Time Frame: After the intravesical therapy (6-week), at the 3-month follow-up, and at 1 year follow-up
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The follow-up assessment rate will be determined by the number of participants who do not complete the post-intervention or follow-up assessments for any reason.
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After the intravesical therapy (6-week), at the 3-month follow-up, and at 1 year follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kerry S Courneya, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEBRA - CC 20-0184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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