The GetMoving Randomized Clinical Trial Protocol: A Perioperative Home-Based (P)Rehabilitation Exercise Intervention in Patients with Bladder Cancer and Upper Tract Urothelial Cancer (Preprint)
Year: 2025
Type: preprint
Study design: Study Protocol
Abstract: BACKGROUND Patients with cancer of the bladder or upper tract are frequently older with a high burden of frailty, sarcopenia, mobility impairment, and multimorbidity, each of which is associated with reduced ability to tolerate invasive treatments and survival. (P)rehabilitation programs are designed to improve functional reserve prior to treatment to mitigate functional decline and optimize post-treatment outcomes and quality of life. Current barriers to widespread prehabilitation program implementation include high costs, time intensity, requirement for in-person therapy, and exercise interventions that are too intense or not feasible to include in clinical care of patients. Digital, home-based (p)rehabilitation strategies offer the potential for scalable adoption, personalization, and integration with electronic health records and routine oncology care. OBJECTIVE This study protocol aims to examine the feasibility, usability, and impact of a (p)rehabilitation exercise intervention delivered via the ExerciseRx digital health platform in patients undergoing treatment for bladder and upper tract urothelial carcinoma (B/UC). METHODS The GetMoving study is a randomized control trial. Following informed consent, participants will be randomized 1:1 to participate in a 4 weeks ((P)REHAB) prescription vs. receiving standard of care (SC) exercise prescription. The study will enroll 102 patients undergoing surgery for treatment of B/UC. The co-primary endpoints are change in physical function between baseline and surgery, as measured by the Short Physical Performance Battery (SPPB) and feasibility evaluated by recruitment, retention, and adherence to the intervention. Secondary endpoints include app useability, change in frailty score, body composition, health-related quality of life (HRQOL), intervention safety ((P)REHAB-related CTCAE), treatment-associated adverse events, postoperative outcomes, Fitbit-assessed step count and sedentary time. RESULTS Institutional review board approval took place on September 19, 2023. This study began patient screening and recruitment in December 2023. CONCLUSIONS This trial aims to evaluate a scalable, pragmatic, home-based digital (P)REHAB program on perioperative physical function, recovery, and quality of life among participants with B/UC undergoing extirpative surgery. CLINICALTRIAL ClinicalTrials.gov, RG1123479; https://clinicaltrials.gov/study/NCT06040762
Language: English
Topic: Cancer survivorship and care
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4406972650