Status:
RECRUITING
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Department of clinical research, Bern
Conditions:
Frail Elderly Syndrome
Major Surgery
Eligibility:
All Genders
65+ years
Phase:
NA
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 spe...
Detailed Description
Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT04461301
Start Date
February 1 2022
End Date
December 30 2026
Last Update
November 1 2024
Active Locations (1)
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1
Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010