EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing cystectomy. The ENHANCE randomized controlled trial.
Recruiting
- Conditions
- bladder tumorbladder cancer10038364
- Registration Number
- NL-OMON54317
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
patients who have histologically confirmed, primary, bladder cancer
(cTa-4N0/N+M0)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of perioperative complications (grade 2 or higher) in the first 90<br /><br>days following surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The number of high-grade (grade 3 or higher) complications, length of hospital<br /><br>stay, number of readmissions, improvement over time (pre- to post surgery) in<br /><br>cardiorespiratory fitness, physical functioning, nutritional status and a<br /><br>number of patient-reported outcomes (health-related quality of life, anxiety<br /><br>and depression, fatigue, levels of physical activity), changes in tumor hypoxia<br /><br>and health care costs.</p><br>