Clinical trial NCT04461301: Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frail Elderly Syndrome
Major Surgery
Keywords: Comprehensive Complication Index
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Department of clinical research, Bern
First posted: 2020-07-08
Enrollment: 466
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial
Primary purpose: TREATMENT

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.

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 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).

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.

Primary outcomes:
measure: Comprehensive Complication Index (CCI)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Cardiovascular & Pulmonary
timeFrame: Before and after 2-4 weeks of prehabilitation, at 30 days
measure: Nutrition & Bioimpendance
timeFrame: At the beginning of study, before and after surgery, at 30 days.
measure: Anaemia
timeFrame: 30 days after surgery
measure: Smoking
timeFrame: At the beginning of study, before and after surgery, at 30 days.
measure: Questionnaires for recovery, anxiety and cardiac risk
timeFrame: At the beginning of study, before and after surgery, at 30 days.
Other outcomes:
measure: Other outcomes of interest
timeFrame: At 30/90 days
Locations:
city: Berne
country: Switzerland
facility: Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
state: BE
Study officials:
affiliation: Department of Anaesthesiology and Pain Therapy, University Hospital Bern
name: Dominique A Engel, Dr
role: PRINCIPAL_INVESTIGATOR
References: