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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
25
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.
Fernanda Zane Arthuso
Edmonton, Alberta, Canada
Changes of Peak Oxygen Consumption (VO2peak)
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).
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Lower body strength
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Upper body strength
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Lower body Flexibility
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Upper body Flexibility
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Agility
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Functional Capacity
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
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Anthropometry and body composition measurements
Height, weight, waist, hip, and calf circumference
Time frame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Health-related quality of life (HRQoL)
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.
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Bladder Cancer-Specific Quality of Life
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.
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
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
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Anxiety
Anxiety will be assessed using the 10-item State-trait Anxiety Inventory. Minimum: 20 Maximum: 80 Higher score= worse anxiety
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Depression
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
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire. questionnaire. Minimum: 0 Maximum: 56 Higher score=worse perceived stress
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Fatigue
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire Minimum: 0 Maximum: 52 Higher score=worse fatigue
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Self-esteem
Self-esteem using the Rosenberg self-esteem scale Minimum: 10 Maximum: 40 Higher score= better self-esteem
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Sleep quality
Sleep quality will be assessed by the Insomnia Severity Index (ISI) Minimum: 0 Maximum: 28 Higher score= worse insomnia
Time frame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Social cognitive predictors of exercise adherence: motivation, perceived benefits, enjoyment, support from others, self-efficacy, and barriers
Standard scales for the Theory of Planned Behaviour
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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