High Intensity PreHab Before Major Abdominal Surgery

Официальное название

Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery

Обзор

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE \<1%), moderate risk (MACE 1-5%) and high risk (MACE \> 5%). In addition with patient related risk factors it can raise to values of 40%. The preoperative aerobic fitness \[oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11 mL/kg/min\] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery. However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients. The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

Подробное описание

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE \<1%), moderate risk (MACE 1-5%) and high risk (MACE \> 5%). In addition with patient related risk factors it can raise to values of 40%.

The preoperative aerobic fitness \[oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11 mL/kg/min\] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.

However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.

The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

Вмешательства

• Процедура Individualized high intensity preoperative fitness training
  The individualised training program consists of stamina training, interval training and strength training. The personalised fitness training will be designed based on the FITT-VP (frequency, intensity, time, type, volume, progression) of the American College of Sports Medicine (ACSM) and will contain 6 training session within 2 weeks under supervision of professional sport physicians.

Первичные конечные точки

• Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] [Срок оценки: 2 weeks]

Вторичные конечные точки (1)

• Quality of Life 36 (QoL-36) describes the quality of life of the patient with a scale ranging from 0 (worst outcome) to 100 (best outcome) between randomisation and end of training hervor surgery [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• ASA I-III
• BMI 18 - 35kg/m2
• Signed informed consent
• Elective abdominal surgery with moderate to high risk

Критерии исключения

• Pregnancy of lactation
• Major trauma or massive haemorrhage with the last two weeks
• Inclusion of the patient in a interventional study
• Contraindication for preoperative fitness training or ergometry
• Transplantation surgery

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

Профилактика

Центры проведения

Австрия · 1 центр

• Medical University Hospital — Innsbruck

Идентификаторы

NCT: NCT05355909 · PreHab in abdominal Surgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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