Improving physical activity before bladder cancer surgery using fitness trackers
Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
This study tests if using fitness trackers to set daily activity goals can help people with bladder cancer get more active before their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsmedizin Mannheim Academic / other |
| Locations | 2 sites (Mannheim, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT06416319 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of fitness wristbands on preoperative physical activity in patients scheduled for radical cystectomy due to bladder cancer. Participants will be randomly assigned to either receive daily activity goals and feedback through the fitness tracker or not. The study aims to determine if this intervention can increase the number of steps taken by participants leading up to their surgery. Each participant will also receive a smartphone to facilitate tracking and communication during the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for radical cystectomy and are mobile without the need for walking aids.
Not a fit: Patients with significant systemic diseases or severe disabilities may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could enhance physical fitness and potentially improve surgical outcomes for bladder cancer patients.
How similar studies have performed: Other studies have shown positive outcomes with preoperative physical activity interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer * Participants age ≥ 18 years and capacity to consent * Mobile participant who is not dependent on a walking aid * The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure Exclusion Criteria: * Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities" * ASA Physical Status Classification: ASA \> 3 (3: A patient with severe systemic disease) * ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.) * Emergency intervention
Where this trial is running
Mannheim, Baden-Wurttemberg and 1 other locations
- Department of Urology, University Medical Center Mannheim, University of Heidelberg — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
- Urologische Klinik München Planegg (UKMP) — München, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Karl-Friedrich Kowalewski, PD Dr. med — Department of Urology, University Medical Center Mannheim, Heidelberg University
- Study coordinator: Karl-Friedrich Kowalewski, PD Dr. med.
- Email: karl-friedrich.kowalewski@umm.de
- Phone: 0152-53404943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.