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Prehabilitation of bladder cancer patients at elevated risk of perioperative mortality to improve outcome after radical cystectomy: Therapy modelling and feasibility study.

Prehabilitation of bladder cancer patients at elevated risk of perioperative mortality to improve outcome after radical cystectomy: Therapy modelling and feasibility study. - PREHAB-Feasibility

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035950
Enrollment
20
Registered
2025-01-21
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: 20 patients with muscle-invasive bladder carcinoma scheduled for radical cystectomy with ISAR score = 2 points or characteristic for multimorbidity (according to the definition of the German

Sponsors

Deutsche Rentenversicherung Hessen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with a diagnosis of a muscle-invasive malignancy of the urinary bladder (urothelial carcinoma or other histological variants) or a non-muscle-invasive high-risk malignancy of the urinary bladder with an oncological indication for radical cystectomy in accordance with the current S3 guideline [1,2]. - Planned cystectomy at the University Hospital Marburg or Giessen. - ECOG (Eastern Cooperative Oncology Group) performance status of = 2 [35] - =3 weeks until radical cystectomy - Sufficient German language skills - Signed written informed consent form - 3 Criteria for patients with an increased risk of complications are examined exploratively: - 1. patients aged = 65 years and an ISAR score = 2 points [34] - 2. patients who are either =80 years or =70 years old and have at least 1 geriatric characteristic for multimorbidity (according to the definition of the German Society for Geriatrics): - Immobility, tendency to fall and dizziness, - cognitive deficits, depression, anxiety disorder - Incontinence (urinary incontinence, rarely fecal incontinence), - Decubitus ulcers, - malnutrition, - disorders of fluid and electrolyte balance, - chronic pain, - sensory disturbances, - reduced physical resilience/frailty, - severe visual impairment, pronounced hearing loss, - recurrent infections, reduced immunocompetence, - multiple medication - Reduced tolerance to medication - frequent hospital stays (revolving door effect). - 3. patients with a score from the American Society of Anesthesiologists physical status classification (ASA) score of 3 or higher.

Exclusion criteria

Exclusion criteria: - Time to surgery < 3 weeks. - Patients with comorbidities or diseases that preclude participation in the exclude participation in the planned training program: - heart failure NYHA IV - Severe pain with or without performing the exercises - Inability to stand or sit independently - Maximum walking time of <6 minutes. - Severe cognitive impairment, assessed by 1. the inability to perform the exercises required for the inclusion examination exercises (walking distance test, short physical performance battery, hand strength test) on instruction. 2. the inability to consent to participation in the study. - Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Feasibility of the study program measured by recruitment, acceptability (Acceptability E-Scale), adherence (logbook).

Secondary

MeasureTime frame
- Physical condition and performance (6-minute walking distance, hand strength test, Short Physical Performance Battery) - Therapy safety - Quality of life (EORTC-QLQ-C30) - Depression and anxiety (PHQ-4) - Postoperative complications

Countries

Germany

Contacts

Public ContactChrister Groeben

Klinik für Urologie, Philipps-Universität Marburg

studien-urologie@uni-marburg.de+4964215866239

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026