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NCT Number: NCT04461301

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Dominique A Engel, Dr

CONTACT

[email protected]

00316322111

Patrick Wuethrich, Prof

CONTACT

[email protected]

00416322111

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Prehabilitation

Procedure

A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).

Primary outcomes

  1. Comprehensive Complication Index (CCI)

    Time frame: 30 days after surgery

    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.

Secondary outcomes

  1. Cardiovascular & Pulmonary

    Time frame: Before and after 2-4 weeks of prehabilitation, at 30 days

    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

  2. Nutrition & Bioimpendance

    Time frame: At the beginning of study, before and after surgery, at 30 days.

    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

  3. Anaemia

    Time frame: 30 days after surgery

    Presence of anaemia, Transfusion rates in the first 30 days after surgery.

  4. Smoking

    Time frame: At the beginning of study, before and after surgery, at 30 days.

    Successful smoking cessation rate, Exhaled CO measured.

  5. Questionnaires for recovery, anxiety and cardiac risk

    Time frame: At the beginning of study, before and after surgery, at 30 days.

    Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI)

Other outcomes

  1. Other outcomes of interest

    Time frame: At 30/90 days

    Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique A Engel, Dr

CONTACT

[email protected]

0041316322111

Patrick Wuethrich, Prof

CONTACT

[email protected]

0041316322111

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Department of clinical research, Bern
  • University of Bern

Registry information

Official study 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).

Acronym: PREHABIL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2020
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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