Home-Based Exercise for Bladder Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Cognitive impairment, Immobility, Nonmuscle-invasive cancer, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant/systemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise before surgery, so it's best to ask the trial coordinators for guidance on your specific medications.
What data supports the effectiveness of this treatment for bladder cancer?
Research suggests that exercise can improve quality of life for bladder cancer survivors and is feasible and effective as part of pre-habilitation (pre-surgery preparation) for those undergoing major surgery. Exercise programs have shown benefits in other cancer groups, indicating potential positive effects for bladder cancer patients as well.
12345Is home-based exercise safe for people with cancer?
Exercise programs, including home-based ones, are generally safe for people with cancer. In a review of 25 studies involving 1434 patients, only 3 out of 711 participants reported minor adverse events related to exercise. Exercise can improve fitness and strength, and may also help prevent complications from cancer treatments.
678910How does home-based exercise differ from other treatments for bladder cancer?
Home-based exercise for bladder cancer is unique because it allows patients to perform aerobic and resistance exercises at home, which can improve their quality of life without the need for supervised sessions. This approach is different from traditional cancer treatments that often require hospital visits and can be more convenient and empowering for patients.
1112131415Eligibility Criteria
This trial is for adults over 18 with non-metastatic muscle-invasive bladder cancer who are English-speaking, scheduled for chemotherapy and surgery, can use a smart device, and consent to participate. Excluded are those with immune deficiencies, severe hearing loss or neuropathy, allergies to platinum drugs, pregnancy, certain heart conditions or psychiatric illnesses that affect compliance.Inclusion Criteria
Willing and able to participate in trial activities
English-speaking
Able to understand and willing to sign written informed consent in English
+4 more
Exclusion Criteria
You are allergic to platinum-based chemotherapy.
You are pregnant or breastfeeding.
Pregnant women are excluded from this study
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Prehabilitation
Participants follow a home-based exercise program using the ExerciseRx app, consisting of four 20-30 minute sessions per week and personalized step count goals, prior to surgery.
4-6 weeks
Remote monitoring via app
Surgery
Participants undergo standard of care surgery for bladder or upper tract urothelial cancer.
Follow-up
Participants are monitored for safety and effectiveness after surgery, including the use of the ExerciseRx app and FitBit for 90 days post-surgery.
3 months
Remote monitoring via app and FitBit
Participant Groups
The trial tests a home-based exercise program delivered via an app (ExerciseRx) to improve physical function before radical cystectomy in bladder cancer patients. It includes core strength exercises and step count goals using wearables and tracks progress through interviews and questionnaires.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A ([P]REHAB intervention)Experimental Treatment6 Interventions
Patients use the ExerciseRx app to follow the (P)REHAB exercise program, which consists of four 20-30 minute home exercise sessions per week and personalized step count goal setting and tracking, prior to SOC surgery and for 90 days following surgery (total \~4-7 months). Patients also download the FitBit app and wear a FitBit throughout the study.
Group II: Arm B (standard of care)Active Control5 Interventions
Patients receive SOC educational materials and wear a FitBit and use the FitBit app prior to SOC surgery and for 90 days following surgery (total \~4-7 months).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Bladder Cancer Advocacy NetworkCollaborator
Bladder Cancer Advocacy NetworkCollaborator
References
Associations between exercise and quality of life in bladder cancer survivors: a population-based study. [2015]Exercise has been shown to improve quality of life (QoL) in some cancer survivor groups, but it is unknown if the unique QoL issues faced by bladder cancer survivors are also amenable to an exercise intervention. This study provides the first data examining the association between exercise and QoL in bladder cancer survivors.
Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. [2018]Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC).
A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy. [2019]Summarizing the evidence on the effects of pre- and postoperative exercise and psychosocial rehabilitation interventions on patient-reported outcomes (PROs) and physical fitness in bladder cancer patients undergoing radical cystectomy.
Scoping review protocol: is there a role for physical activity interventions in the treatment pathway of bladder cancer? [2020]Patients with bladder cancer (BC) have been found to have worse experiences than those with other cancers which may partly be due to impact on quality of life. Currently, little is known about the impact of physical activity (PA) on BC outcomes. This scoping review aims to identify what interventions are available, their reported efficacy and feasibility, and a description of potential underlying biological mechanisms for their effects.
The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial. [2014]Assessment of feasibility and effects of an exercise training programme in patients following cystectomy due to urinary bladder cancer.
Effects of Exercise Programs on Physical Factors and Safety in Adult Patients with Cancer and Haematopoietic Stem Cell Transplantation: A Systematic Review. [2022]This study looks at the effects of exercise programs on physical factors and safety in adult patients with cancer and hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation (BMT). A systematic search was performed in the PubMed and Web of Science databases (from inception to 26 August 2021). A review was carried out following the Preferred Reporting Items for Systematic review and Meta-Analyses (PRISMA) checklist. The methodological quality of the included studies was assessed with the Physiotherapy Evidence Database (PEDro) scale, based, in turn, on the Delphi list. A total of 25 randomized controlled trials studies were included, comprising 1434 patients. The most significant result of this systematic review is that exercise program interventions are safe and produce positive changes in cardiorespiratory fitness, muscle strength, and the functional mobility-state in adult patients with cancer and HSCT or BMT. Only 3 patients from the 711 participants in the exercise interventions (i.e., 0.42%) reported adverse events related to exercise interventions. Moreover, exercise training programs may have a cardiological and muscular protective effect, as well as a healthy effect on the prevention and control of transplant complications, improving health outcomes.
The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. [2018]Cancer treatment is associated with adverse changes in strength, body composition, physical function, and quality of life. Exercise training reduces cancer incidence and mortality rates and may offset some of the treatment-related effects. To determine the independent effects of strength training (ST) on the effects of cancer treatment, an initial search was performed in March and then updated in November 2015. Additional articles were identified by scanning references from relevant articles. Studies using traditional ST on strength, body composition, aerobic capacity, functional assessments, and psychosocial parameters were included. Excluded studies had no objective strength measurement or combined ST with additional exercise. Mean and standard deviations from 39 studies across seven cancer types were extracted for main outcomes. ST-induced change scores with 95% confidence intervals were calculated and were evaluated with paired t tests, where appropriate. Twenty to fifty percent improvements in maximal strength were observed, indicating that the ST programs were effective. Physical function was also enhanced (7-38%), although gains were less consistent. Body composition and psychosocial changes were rare, with only a few changes in selected cancer types. As such, ST appears to promote benefits that may be specific to cancer types. Strength was the only consistent outcome that improved in all cancer survivors. However, these gains in strength are still of tremendous importance, given its impact on functionality and quality of life. Several practical considerations for exercise testing, training, and data reporting are presented for consideration to improve the overall depth of the field.
Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]Adequate, transparent, and consistent reporting of adverse events (AEs) in exercise oncology trials is critical to assess the safety of exercise interventions for people following a cancer diagnosis. However, there is little understanding of how AEs are reported in exercise oncology trials. Thus, we propose to conduct a scoping review to summarise and evaluate current practice of reporting of AEs in published exercise oncology trials with further exploration of factors associated with inadequate reporting of AEs. The study findings will serve to inform the need for future research on standardisation of the definition, collection, and reporting of AEs for exercise oncology research.
Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015.Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I-IV; primary/recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise.ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes.ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality.
Evaluation of the Structure and Health Impacts of Exercise-Based Cardiac and Pulmonary Rehabilitation and Prehabilitation for Individuals With Cancer: A Systematic Review and Meta-Analysis. [2023]Exercise-based, multimodal rehabilitation programming similar to that used in the existing models of cardiac or pulmonary rehabilitation or prehabilitation is a holistic potential solution to address the range of physical, psychological, and existential (e.g., as their diagnosis relates to potential death) stressors associated with a cancer diagnosis and subsequent treatment. The purpose of this study was to systematically evaluate the structure and format of any type of exercise-based, multimodal rehabilitation programs used in individuals with cancer and the evidence base for their real-world effectiveness on metrics of physical (e.g., cardiorespiratory fitness, blood pressure) and psychological (e.g., health-related quality of life) health. Very few of the 33 included exercise-based, multimodal rehabilitation programs employed intervention components, education topics, and program support staff that were multi-disciplinary or cancer-specific. In particular, a greater emphasis on nutrition care, and the evaluation and management of psychosocial distress and CVD risk factors, with cancer-specific adaptations, would broaden and maximize the holistic health benefits of exercise-based rehabilitation. Despite these opportunities for improvement, exercise-based, multimodal rehabilitation programs utilized under real-world settings in individuals with cancer produced clinically meaningful and large effect sizes for cardiorespiratory fitness (VO2peak, ±2.9 mL/kg/min, 95% CI = 2.6 to 3.3) and 6-minute walk distance (+47 meters, 95% CI = 23 to 71), and medium effect sizes for various measures of cancer-specific, health-related quality of life. However, there were no changes to blood pressure, body mass index, or lung function. Overall, these findings suggest that exercise-based, multimodal rehabilitation is a real-world therapy that improves physical and psychological health among individuals with cancer, but the holistic health benefits of this intervention would likely be enhanced by addressing nutrition, psychosocial concerns, and risk factor management through education and counselling with consideration of the needs of an individual with cancer.
Effects of a home-based exercise rehabilitation program for cancer survivors. [2019]Aerobic and resistance exercises have been promoted recently to improve quality of life in cancer patients. Most cancer survivorship rehabilitation programs consist of supervised exercise programs; however, less data is available on the effects of unsupervised or home-based exercise interventions. The study aimed to compare the physical and physiologic changes in a group of cancer survivors (CS) and a control group of non-cancer, health controls (HC) who participated in individualized home-based aerobic and resistance exercises for 12 months.
Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial. [2023]The number of people living with the side effects of breast cancer treatment (eg, loss of muscular mass and muscular strength, upper-limb mobility and disability, lymphedema, cardiac toxicity, and reduced quality of life) is increasing yearly. These consequences can be improved through exercise, specially combining resistance and aerobic training. Previous exercise trials have not been consistent in applying training principles and standardized reporting, and this partly explains the variability in obtained results. The aim of this study is to assess the effect of a 12-week supervised resistance exercise program combined with home-based aerobic exercise, compared with home-based aerobic exercise only, on muscular strength and several aspects of health-related quality of life in breast cancer survivors. To maximize transparency, replicability, and clinical applicability, the intervention is described following the consensus on exercise reporting template.
The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience. [2021]Health-related exercise and education program for cancer patients are necessary to provide physical and emotional support to enable efficient and appropriate self-management at home.
Effects of a 12-week home-based exercise program on the level of physical activity, insulin, and cytokines in colorectal cancer survivors: a pilot study. [2022]The purposes of this study are to examine (1) the feasibility and efficacy of two different home-based exercise protocols on the level of physical activity (PA), and (2) the effect of increased PA via home-based exercise program on biomarkers of colorectal cancer.
Effects of home-based exercise on exercise capacity, symptoms, and quality of life in patients with lung cancer: A meta-analysis. [2021]The aim of this study was to evaluate the effects of home-based exercise on exercise capacity, cancer-related fatigue, insomnia, pain, appetite loss, coughing, anxiety, depression, and quality of life of patients with lung cancer.