Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)

NCT06416319 | Recruiting

• 1 other identifier: 2021-677
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.

Conditions

Bladder Cancer; Bladder Neoplasm; Bladder Urothelial Carcinoma

Keywords

Cystectomy; Preoperative Exercise; Fitness Trackers; Exercise; Frailty

Outcome Measures

Primary Outcomes (1)

• Number of steps per day

  Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.

  Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.

Secondary Outcomes (13)

• Total number of steps

  Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.

• Postoperative physical activity

  Morning of postoperative day 4 at 7 PM

• Postoperative Complications

  On postoperative day 30 and 90

• Operating time

  On the day of surgery

• Blod loss

  On the day of surgery

Study Arms (2)

Daily Activity Goal and Feedback

EXPERIMENTAL

The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active.

Device: Daily Activity Goal and Feedback

No Daily Activity Goal or Feedback

NO INTERVENTION

The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications.

Interventions

Daily Activity Goal and Feedback DEVICE

The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal.

Daily Activity Goal and Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead
• Dr. Rolf M. Schwiete Foundation: collaborator

Study Sites (2)

Department of Urology, University Medical Center Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Urologische Klinik München Planegg (UKMP)

München, Bavaria, Germany

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Motor Activity; Frailty

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl-Friedrich Kowalewski, PD Dr. med

  Department of Urology, University Medical Center Mannheim, Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl-Friedrich Kowalewski, PD Dr. med.

CONTACT

0152-53404943; karl-friedrich.kowalewski@umm.de

Johannes Kilz

CONTACT

0162-5297396; johanneskilz@stud.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Senior Physician

Model Details: Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period.

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 16, 2024
• Study Start: March 14, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

DE (2)