Clinical trial · Interventional
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation group
- description
- The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.
- interventionNames
- Behavioral: Prehabilitation
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0), * Planned to undergo radical cystectomy, * Age ≥ 18 years. Exclusion Criteria: * Subjects with severe cognitive or psychiatric disorders, * Subjects who are operated within 3 weeks, * Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires, * Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET), * Subject who are unable or unwilling to participate in the intervention.
References
Publications (1)
- DERIVEDAkdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304. PMID 36882246