Prehabilitation program for elderly patients undergoing major surgery
Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).
This study tests if a special program that includes exercise, better nutrition, and other health improvements can help older patients recover better after major surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 466 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern, Canton of Bern) |
| Trial ID | NCT04461301 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to implement a multimodal, multidisciplinary prehabilitation approach to reduce postoperative complications and enhance recovery in elderly, frail patients scheduled for major surgery. The study involves two groups: one receiving standard care and the other participating in a prehabilitation program that includes exercise training, nutritional intervention, correction of anemia, and smoking cessation. By addressing various factors that affect surgical outcomes, the trial seeks to improve the overall health and recovery of elderly patients before undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates are elderly patients with comorbidities scheduled for major surgery who have a pre-existing fitness deficit.
Not a fit: Patients with mobility issues, cognitive disabilities, or those requiring emergency procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and improve recovery times for elderly patients undergoing major surgery.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches in surgical patients, indicating potential for success in this novel implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * comorbid (≥ASA 3) * pre-existing fitness deficit: AT\<11ml/kg/min respectively VO2peak\<14ml/kg/min if AT unavailable or VE/VCO2 slope \> 33 * scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery * screening at least 2 weeks prior to surgery Exclusion Criteria: * Paralysis or patients with mobility problems (who are unable to exercise), * Premorbid conditions or orthopaedic impairments that contraindicate exercise, * Cognitive disabilities, * Chronic renal failure (need for dialysis) * Emergency procedures.
Where this trial is running
Bern, Canton of Bern
- Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern — Bern, Canton of Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Dominique A Engel, Dr — Department of Anaesthesiology and Pain Therapy, University Hospital Bern
- Study coordinator: Dominique A Engel, Dr
- Email: dominique.engel@insel.ch
- Phone: 0041316322111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.