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

Launched by UNIVERSITÄTSMEDIZIN MANNHEIM · May 10, 2024

Keywords

ClinConnect Summary

The PreAct trial is studying whether using fitness wristbands can help patients with bladder cancer become more physically active before they undergo a major surgery called radical cystectomy. This surgery involves removing the bladder and may include other procedures to help with urine flow. The goal of the trial is to see if tracking physical activity, like daily steps, can lead to an increase in exercise during the weeks leading up to the surgery.

To be eligible for this trial, participants must be at least 18 years old, be able to walk without assistance, and have a scheduled radical cystectomy. They need to be able to understand and agree to participate in the study by signing a consent form. If someone joins the trial, they can expect to wear a fitness tracker that will monitor their activity levels and help encourage them to stay active before their surgery. This study is currently recruiting participants, and being a part of it may help improve their health and recovery after the operation.

Gender

ALL

Eligibility 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