Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Major Surgery; Frail Elderly Syndrome

Treatments: Procedure: Multimodal Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04461301

PREHAB2020

Details and patient eligibility

About

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.

Full 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).

Enrollment: 466 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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466 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.

Treatment:

Procedure: Multimodal Prehabilitation

Control

No Intervention group

Description:

Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.