Skip to content

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing cystectomy. The ENHANCE randomized controlled trial.

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing cystectomy. The ENHANCE randomized controlled trial. - ENHANCE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54317
Enrollment
148
Registered
2022-07-11
Start date
2022-08-11
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

bladder tumor

Interventions

Patients will be randomized to either an intervention group or to a usual care control group (1:1 allocation). The intervention group will receive a structured multimodal prehabilitation program con

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients who have histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0)

Exclusion criteria

Exclusion criteria: Patients with severe cognitive or psychiatric disorders; patients who are operated within 3 week; patients with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires; patients who have contraindications to safely perform exercise training or testing, and; patients who express the intention to follow a similar exercise training programme regardless of randomisation outcome.

Design outcomes

Primary

MeasureTime frame
The number of perioperative complications (grade 2 or higher) in the first 90 days following surgery.

Secondary

MeasureTime frame
The number of high-grade (grade 3 or higher) complications, length of hospital stay, number of readmissions, improvement over time (pre- to post surgery) in cardiorespiratory fitness, physical functioning, nutritional status and a number of patient-reported outcomes (health-related quality of life, anxiety and depression, fatigue, levels of physical activity), changes in tumor hypoxia and health care costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026