Skip to main content
OpenTrials
Completed

NCT Number: NCT04593862

Bladder Cancer and ExeRcise Training During IntraVesical ThErapy

Bladder cancer is the fifth most common cancer in Canada and has the eighth highest cancer mortality rate. The treatment for the most frequent type of bladder cancer is surgically removing the tumour followed by six weeks of medication placed within the bladder. There are physical and psychosocial challenges from bladder cancer and its treatment that may affect how patients feel and function, and consequently their quality of life. Moreover, bladder cancer patients are at a high risk of their bladder cancer coming back and getting worse. Exercise is a low-cost intervention that may lower the chances of bladder cancer coming back or getting worse, manage side effects related to treatment, help patients feel better, and improve quality of life. To date, however, no study has examined if it is safe or even possible for bladder cancer patients to exercise when they are receiving drugs placed into their bladder. The Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) Trial will be the first study to test the safety, feasibility, and efficacy of exercise in bladder cancer patients during this drug therapy. The investigators will ask some patients to do a supervised exercise program during their drug treatment while other patients will be asked not to exercise. The investigators will compare the 2 groups on how they fare with their bladder cancer treatment. This study will provide information on whether exercise may help patients feel better, function better, and possibly even lower their chances of the disease coming back or getting worse.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Behavior Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fernanda Zane Arthuso

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity interval training

Other

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.

Primary outcomes

  1. Changes of Peak Oxygen Consumption (VO2peak)

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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).

Secondary outcomes

  1. Lower body strength

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  2. Upper body strength

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  3. Lower body Flexibility

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  4. Upper body Flexibility

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  5. Agility

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  6. Functional Capacity

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    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

  7. Anthropometry and body composition measurements

    Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up

    Height, weight, waist, hip, and calf circumference

  8. 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

    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.

  9. 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

    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.

  10. 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

    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

  11. Anxiety

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    Anxiety will be assessed using the 10-item State-trait Anxiety Inventory.

    Minimum: 20 Maximum: 80 Higher score= worse anxiety

  12. Depression

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    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

  13. Perceived Stress

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.

    questionnaire.

    Minimum: 0 Maximum: 56 Higher score=worse perceived stress

  14. Fatigue

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire

    Minimum: 0 Maximum: 52 Higher score=worse fatigue

  15. Self-esteem

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    Self-esteem using the Rosenberg self-esteem scale

    Minimum: 10 Maximum: 40 Higher score= better self-esteem

  16. Sleep quality

    Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up

    Sleep quality will be assessed by the Insomnia Severity Index (ISI)

    Minimum: 0 Maximum: 28 Higher score= worse insomnia

  17. 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

    Standard scales for the Theory of Planned Behaviour

Other outcomes

  1. Complete response

    Time frame: 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up

    Negative cytology, imaging, and cystoscopy and, when the TURBT is indicated, a negative biopsy.

  2. Intravesical therapy adherence

    Time frame: 6-week follow-up

    Intravesical therapy adherence will be tracked by medical records of attendance and self-report drug retention time

  3. Treatment toxicities

    Time frame: 6-week follow-up

    Treatment toxicities will be abstracted from medical records

  4. Incidence of Adverse events related to the High-Intensity Interval Training during Intravesical Therapy

    Time frame: Through study completion, an average of 1 year

    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.

  5. Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval

    Time frame: At baseline

    The eligibility rate will be the number of non-muscle invasive bladder cancer patients

  6. Recruitment rate of non-muscle invasive bladder cancer patients to a high-intensity interval training during Intravesical Therapy

    Time frame: At baseline

    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.

  7. 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

    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.

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Cross Cancer Institute
  • Northern Alberta Urology Centre

Registry information

Official study title

Feasibility and Preliminary Efficacy of High-Intensity Interval Training in Bladder Cancer Patients Receiving Intravesical Therapy: a Randomized Controlled Trial

Acronym: BRAVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.