Multimodal Prehabilitation for Surgery in the Elderly: A Randomised, Prospective, Multicenter, Multidisciplinary Trial

Frail Elderly Syndrome Clinical Trial

— PREHABIL  

Official title:

Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: A Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461301
• Other study ID #: PREHAB2020
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Major Surgery

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.