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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Comprehensive Complication Index (CCI) [Срок оценки: 30 days after surgery]

Вторичные конечные точки (5)

• Cardiovascular & Pulmonary [Срок оценки: Before and after 2-4 weeks of prehabilitation, at 30 days]
• Nutrition & Bioimpendance [Срок оценки: At the beginning of study, before and after surgery, at 30 days.]
• Anaemia [Срок оценки: 30 days after surgery]
• Smoking [Срок оценки: At the beginning of study, before and after surgery, at 30 days.]
• Questionnaires for recovery, anxiety and cardiac risk [Срок оценки: At the beginning of study, before and after surgery, at 30 days.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

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

Публикации

• Dueblin SW, Wuethrich PY, Engel D, Eser P, Beilstein CM, Wilhelm M, Vetsch T. Inspiratory muscle training as part of multimodal prehabilitation improves maximal inspiratory pressure in elderly surgical patients: an exploratory secondary analysis of a randomised controlled trial. BMC Geriatr. 2026 Jul 7. doi: 10.1186/s12877-026-07944-3. Online ahead of print. PMID 42414962
• Vetsch T, Dueblin SW, Eser P, Beilstein CM, Wuethrich PY, Wilhelm M, Engel D. Effect of multimodal home-based prehabilitation on objectively measured physical activity in patients undergoing elective cardiac or non-cardiac major surgery: secondary outcomes from a randomised controlled trial. Perioper Med (Lond). 2025 Jul 4;14(1):69. doi: 10.1186/s13741-025-00554-4. PMID 40615882
• Beilstein CM, Krutkyte G, Vetsch T, Eser P, Wilhelm M, Stanga Z, Bally L, Verra M, Huber M, Wuethrich PY, Engel D. Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial). BMJ Open. 2023 Jan 3;13(1):e070253. doi: 10.1136/bmjopen-2022-070253. PMID 36596634

Идентификаторы

NCT: NCT04461301 · PREHAB2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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