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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04461301
Other study ID # PREHAB2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date August 30, 2025

Study information

Verified date March 2023
Source University Hospital Inselspital, Berne
Contact Dominique A Engel, Dr
Phone 0041316322111
Email dominique.engel@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future. This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT). The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. 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, morbid patients. The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).


Recruitment information / eligibility

Status Recruiting
Enrollment 466
Est. completion date August 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Multimodal Prehabilitation
A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).

Locations

Country Name City State
Switzerland Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern Berne BE

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Other outcomes of interest Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days At 30/90 days
Primary Comprehensive Complication Index (CCI) The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally. 30 days after surgery
Secondary Cardiovascular & Pulmonary Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score Before and after 2-4 weeks of prehabilitation, at 30 days
Secondary Nutrition & Bioimpendance Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth At the beginning of study, before and after surgery, at 30 days.
Secondary Anaemia Presence of anaemia, Transfusion rates in the first 30 days after surgery. 30 days after surgery
Secondary Smoking Successful smoking cessation rate, Exhaled CO measured. At the beginning of study, before and after surgery, at 30 days.
Secondary Questionnaires for recovery, anxiety and cardiac risk Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI) At the beginning of study, before and after surgery, at 30 days.
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