Effects of CPRP on Patients Undergoing Lung Resection
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
- В протоколе указаны: Standard care, Comprehensive pulmonary rehabilitation programs.
- Кому может быть актуально
- Состояния в реестре: Rehabilitation. Базовые параметры: от 20 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial
Обзор
The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population.
Подробное описание
Background: Elderly patients with compromised lung function or poor health conditions undergoing lung resection surgery face an increased risk of postoperative pulmonary complications. Pulmonary rehabilitation programs play a crucial role in enhancing recovery after surgery, having been shown to reduce postoperative pulmonary complications and enhance patients' pre- and post-operative exercise capacity, functional performance, and quality of life. However, due to the heterogeneity of interventions in pulmonary rehabilitation programs, the optimal timing, methods, or duration of exercise training for lung resection patients remain unclear. Additionally, there is a lack of comprehensive research on the changes and impacts of biomarkers in the blood of lung resection patients following intervention with pulmonary rehabilitation programs.
Objectives: This study aims to investigate the physiological and biological effects of a comprehensive pulmonary rehabilitation program in lung resection surgery patients with limited exercise capacity and impaired lung function.
Research Methods: This study adopts an open label, randomized, parallel design, intending to recruit 96 lung resection surgery participants divided into a control group receiving standard care and an experimental group receiving the comprehensive pulmonary rehabilitation programs. The intervention period spans 1-2 weeks pre-surgery, during hospitalization, and 3-6 weeks post-discharge. Participants will undergo four assessments at randomization (baseline, T0), one day pre-surgery (T1), the day of discharge post-surgery (T2), and at trial completion (T3). The primary endpoint is the six-minute walk test. Secondary endpoints include lung function, lung expansion volume, respiratory muscle strength, incidence of postoperative complications and pulmonary complications, chest tube duration, length of hospital stay, quality of life (EORTC QLQ-C30), and pain. Exploratory endpoints involve inflammation-related and immune-related biomarkers.
Expected Impact: This study will provide valuable insights into the physiological and biological effects of a comprehensive pulmonary rehabilitation programs for lung resection surgery patients. Results may contribute to improving patient outcomes and advancing academic understanding and clinical guidelines in this field.
Вмешательства
- Другое Standard care
The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) adminis - Другое Comprehensive pulmonary rehabilitation programs
1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk 2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages. 3. The resistance
Первичные конечные точки
- Six-minute walk distance (6MWD) [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
Вторичные конечные точки (8)
- Pulmonary function test [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Respiratory muscle strength [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Length of hospital stay (LoS) [Срок оценки: an average of post-surgery 2 weeks]
- Duration of chest-tube insertion [Срок оценки: an average of post-surgery 2 weeks]
- Numerical Rating Scale (NRS) [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan)) [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Postoperative complications (POCs) and postoperative pulmonary complications (PPCs) [Срок оценки: an average of post-surgery 2 weeks]
- Lung expansion volume [Срок оценки: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
Критерии участия
Критерии включения
- Adults (age ≥ 20 years old)
- Receiving lung resection surgery
- At least one of the following:
6MWD < 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2< 90% during 6MWT, pre-operative forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7
- Able to walk autonomously without mobility aids
- Written informed consent
Критерии исключения
- Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery
- Received pulmonary rehabilitation programs six months prior to surgery
- Previous lung resection
- Inability to perform the exercise training
- Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions
- Have cognitive deficits with potential severe impact on compliance
- Do not provide written informed consent
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Chang Gung Memorial Hospital — Chiayi City
Идентификаторы
NCT: NCT06432634 · 202400512B0