Feasibility and Preliminary Efficacy of High-Intensity Interval Training in Bladder Cancer Patients Receiving Intravesical Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Changes of Peak Oxygen Consumption (VO2peak)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators will not be blinded to group assignment given the nature of the intervention. Outcome assessors will be blinded to group assignment for the clinical outcomes of tumour recurrence and progression.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes of Peak Oxygen Consumption (VO2peak)
时间窗: 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).
次要结局
- Health-related quality of life (HRQoL)(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Self-esteem(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Lower body Flexibility(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Functional Capacity(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- 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)
- Anxiety(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Fatigue(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Upper body Flexibility(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Depression(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Lower body strength(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Anthropometry and body composition measurements(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Perceived Stress(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(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Sleep quality(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)
- Upper body strength(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Agility(At baseline, after the intravesical therapy (6-week), and 3-month follow-up)
- Bladder Cancer-Specific Quality of Life(At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up)