NCT04461301 Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
| NCT ID | NCT04461301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Frail Elderly Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 466 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 466 participants in total. It began in 2022-02-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
Eligibility 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.
Contact & Investigator
Dominique A Engel, Dr
PRINCIPAL INVESTIGATOR
Department of Anaesthesiology and Pain Therapy, University Hospital Bern
Frequently Asked Questions
Who can join the NCT04461301 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Frail Elderly Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04461301 currently recruiting?
Yes, NCT04461301 is actively recruiting participants. Contact the research team at dominique.engel@insel.ch for enrollment information.
Where is the NCT04461301 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04461301 clinical trial?
NCT04461301 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Dominique A Engel, Dr at Department of Anaesthesiology and Pain Therapy, University Hospital Bern. The trial plans to enroll 466 participants.