Home-Based Exercise for Bladder Cancer

Overseen By Get Moving Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Cognitive impairment, Immobility, Nonmuscle-invasive cancer, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Research Team

Sarah Psutka

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility 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

Exclusion Criteria

You are allergic to platinum-based chemotherapy.

You are pregnant or breastfeeding.

Pregnant women are excluded from this study

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

Treatment Details

Interventions

• Exercise Intervention

Trial Overview 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.

Participant Groups

Group I: Arm A ([P]REHAB intervention) Experimental Treatment 6 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 Control 5 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).

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Bladder Cancer Advocacy Network

Collaborator

Trials

2

Recruited

190+

Bladder Cancer Advocacy Network

Collaborator

Trials

4

Recruited

430+

Findings from Research

In a survey of 525 bladder cancer survivors, only 22.3% met public health exercise guidelines, highlighting a significant gap in physical activity among this group.

Those who met exercise guidelines reported significantly better quality of life scores across various domains, including functional well-being and sexual functioning, compared to those who were completely sedentary, suggesting that exercise may improve QoL for bladder cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Karvinen, KH., Courneya, KS., North, S., et al.[2015]

A short-term exercise-based pre-habilitation program for patients with invasive bladder cancer awaiting radical cystectomy showed a high adherence rate of 66%, indicating that most patients were able to follow the recommended exercise regimen.

The intervention group experienced a significant improvement in muscle power of 18% at the time of surgery compared to the standard group, suggesting that pre-habilitation can enhance physical strength and potentially improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. Jensen, BT., Laustsen, S., Jensen, JB., et al.[2018]

Exercise interventions for bladder cancer patients undergoing radical cystectomy showed positive effects on physical fitness and some health-related quality-of-life measures, based on a review of 6 studies involving 317 patients.

Psychosocial interventions were beneficial in reducing anxiety, fatigue, and depression, as well as improving overall health-related quality of life, although the evidence for both exercise and psychosocial interventions remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy. Rammant, E., Decaestecker, K., Bultijnck, R., et al.[2019]

This scoping review aims to explore the impact of physical activity on bladder cancer outcomes, focusing on available interventions, their efficacy, and feasibility, as well as potential biological mechanisms involved.

The study will follow rigorous guidelines and involve consultations with patients and healthcare professionals to ensure that findings are relevant and can inform future physical activity interventions for bladder cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scoping review protocol: is there a role for physical activity interventions in the treatment pathway of bladder cancer? Mehrotra, S., Rowland, M., Zhang, H., et al.[2020]

A 12-week exercise program for patients who underwent cystectomy due to bladder cancer showed significant improvements in walking distance and health-related quality of life, particularly in the role-physical domain, compared to a control group that received only standard information.

Despite the positive outcomes, the program was not feasible for most patients, as many eligible individuals chose not to participate or dropped out before randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial. Porserud, A., Sherif, A., Tollbäck, A.[2014]

Exercise programs are safe for adult cancer patients undergoing hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation (BMT), with only 0.42% of participants reporting adverse events related to exercise.

These exercise interventions lead to significant improvements in cardiorespiratory fitness, muscle strength, and functional mobility, suggesting they may also help prevent and manage complications associated with transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Programs on Physical Factors and Safety in Adult Patients with Cancer and Haematopoietic Stem Cell Transplantation: A Systematic Review. Morales-Rodriguez, E., Pérez-Bilbao, T., San Juan, AF., et al.[2022]

Strength training (ST) significantly improves maximal strength in cancer survivors, with increases ranging from 20% to 50%, demonstrating its effectiveness in countering treatment-related declines in strength.

While ST also enhances physical function by 7% to 38%, improvements in body composition and psychosocial parameters were less consistent, indicating that strength gains are the most reliable benefit across various cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. Hanson, ED., Wagoner, CW., Anderson, T., et al.[2018]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

Exercise-based, multimodal rehabilitation programs for cancer patients have shown significant improvements in physical health, particularly in cardiorespiratory fitness and walking distance, with clinically meaningful effect sizes.

To enhance the overall benefits of these rehabilitation programs, there is a need for greater focus on nutrition, psychosocial support, and management of cardiovascular risk factors tailored specifically for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rickard, JN., Eswaran, A., Small, SD., et al.[2023]

A 12-month home-based exercise program for 33 cancer survivors led to significant reductions in waist circumference and improvements in body composition and lower body muscle strength, indicating positive physical changes.

The exercise intervention was found to be safe and cost-effective, with no adverse effects on cardiac function, suggesting that unsupervised exercise can be beneficial for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise rehabilitation program for cancer survivors. Stefani, L., Klika, R., Mascherini, G., et al.[2019]

A 12-week supervised resistance exercise program combined with home-based aerobic exercise is being tested on 60 female breast cancer survivors to see if it improves muscular strength and health-related quality of life compared to aerobic exercise alone.

The study aims to provide clear and standardized reporting of the exercise intervention, which could help improve future exercise prescriptions for breast cancer survivors dealing with treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Soriano-Maldonado, A., Carrera-Ruiz, Á., Díez-Fernández, DM., et al.[2023]

A study involving 72 cancer patients showed that a combined program of physical exercise, education, and emotional support significantly reduced illness stress and improved health promotion lifestyle after 10 weeks, particularly in areas like social relationships and stress management.

While the program effectively lowered stress and enhanced lifestyle, it did not significantly impact hope and resilience, indicating a need for further research to address these emotional aspects in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience. Sung, KM., Yu, M., Kang, YS., et al.[2021]

A 12-week home-based exercise program significantly increased physical activity levels in colorectal cancer survivors, with no difference in effectiveness between a casually intervened and an intensely intervened group.

Increased physical activity led to beneficial changes in biomarkers associated with colorectal cancer, including reduced insulin and TNF-α levels, and increased IGF-1 and adiponectin levels, indicating potential health benefits for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lee, DH., Kim, JY., Lee, MK., et al.[2022]

A study involving 694 lung cancer patients found that home-based exercise significantly improved exercise capacity, reduced cancer-related fatigue, insomnia, anxiety, and depression, and enhanced overall quality of life.

Despite these benefits, home-based exercise did not significantly alleviate pain, appetite loss, or coughing symptoms, suggesting it is effective for certain aspects of patient well-being but not all.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based exercise on exercise capacity, symptoms, and quality of life in patients with lung cancer: A meta-analysis. Yang, M., Liu, L., Gan, CE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Scoping review protocol: is there a role for physical activity interventions in the treatment pathway of bladder cancer? [2020]

5. England pubmed.ncbi.nlm.nih.gov

The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Exercise Programs on Physical Factors and Safety in Adult Patients with Cancer and Haematopoietic Stem Cell Transplantation: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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]

11. Italy pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise rehabilitation program for cancer survivors. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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]

13. United States pubmed.ncbi.nlm.nih.gov

The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

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]

15. Scotland pubmed.ncbi.nlm.nih.gov

Effects of home-based exercise on exercise capacity, symptoms, and quality of life in patients with lung cancer: A meta-analysis. [2021]