PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Prehabilitation. Базовые параметры: 65 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Сингапур
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional
Обзор
Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients with MIP\<100 cmH2O. Currently, Singapore General Hospital offers the "Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE)" program, targeting frail patients undergoing major surgery. The primary outcome of the study is the change in physical function, measured by handgrip strength (HGS), from baseline to 3 days before surgery. Secondary outcomes include changes in the 6-minute walk test (6MWT), maximal inspiratory pressure (MIP), and sit-to-stand (STS) parameters from baseline to 3 days before surgery and 4-5 weeks postoperatively. Additionally, study will also assess postoperative complications (using the Comprehensive Complication Index), postoperative morbidity (using the Postoperative Morbidity Survey), length of hospital stay (LOS), and Health-Related Quality of Life (HRQoL) outcomes.
Подробное описание
The exercise instructions given in the PREPARE program are part of the standard treatment and care is taken to ensure that the exercises are done safely at home. The only research segment is measurement of the parameters and clinical outcomes."
Patient Visits: 1. Recruitment/Enrollment (Visit 1 - coincide with PAC visit) Once informed consent is obtained. Patients will have the following measurements taken.
1. Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer, 2. 6-minute walk test (6MWT), 3. handgrip strength (HGS) of the dominant hand, and 4. 30s and 1-minute Sit-To-Stand (STS).
In addition, all patients will receive the routine (20 - 40 minutes) preoperative physiotherapy education, home exercise instructions and inspiratory muscle training (if MIP \< 100 cmH2O).
2\. Follow up (Phone call) Patients will receive follow-up phone calls once weekly to check if they have any problems following the home exercise instructions given to them on visit 1.
3\. Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.
4\. Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.
Первичные конечные точки
- The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength [Срок оценки: Baseline]
Вторичные конечные точки (6)
- Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT [Срок оценки: Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively]
- Change in functional parameters : handgrip strength [Срок оценки: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively]
- 30-day postoperative complications that will be assessed using the Comprehensive ComplicationIndex (CCI) [Срок оценки: Up to 30 days after operation]
- Change in Health Related Quality of Life (HRQoL) outcomes, measured by the EQ-5D-3L, pre and post-operatively. [Срок оценки: Baseline and pre-operation (4-5 weeks after op)]
- 30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS) [Срок оценки: Up to 30 days after operation]
- Change in functional parameters 30s and 1-min Sit to stand [Срок оценки: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively]
Критерии участия
Критерии включения
- Aged over 65 years who are undergoing elective major non-cardiac surgery
- Edmonton Frail Score (EFS) of 6 or higher
Критерии исключения
- Patients who are unable to provide written informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Сингапур · 1 центр
- Singapore General Hospital — Singapore
Идентификаторы
NCT: NCT06620588 · PREPARE24