Longitudinal Changes in the ADL-Glittre Test in Patients With Lung Cancer: Pre- and Postoperative Analysis Using Rehabilitation in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test).
研究概览
简要总结
Lung cancer is the most common type of cancer and the leading cause of cancer death worldwide, in both men and women. Improvements in earlier preoperative staging and more effective adjuvant treatment have improved survival in non-small cell lung cancer, although surgical resection remains the mainstay of care for all patients in stages I to IV.
This study proposes to evaluate the functional capacity through TGlittre in patients with non-small cell lung cancer, before and after thoracic surgery, taking into account the predictive role of this test in the risk of complications and in the evaluation of the impact of functional rehabilitation.
详细描述
In the population of patients with lung cancer, two critical points that constitute gaps in the literature are: 1) the definition of operability using only pulmonary function tests and the consequent preparation of the patient for the surgical act; and 2) the postoperative approach and the consequent screening aimed at improving quality of life and reducing morbidity. In addition to the sophistication of pulmonary rehabilitation that has occurred in recent decades, the ADL-Glittre test was also developed, which is a measure of submaximal effort that assesses functional capacity and encompasses several tasks that simulate activities of daily living involving both lower limbs the higher, being an easy to administer, valid and reliable test to measure the functional status. This study proposes to evaluate the functional capacity through TGlittre in patients with non-small cell lung cancer, before and after thoracic surgery, taking into account the predictive role of this test in the risk of complications and in the evaluation of the impact of functional rehabilitation. As specific objectives, this study seeks to: test the reliability and validity of TGlittre in patients with non-small cell lung cancer; compare the results of TGlittre with those of lung function and quality of life in the pre- and postoperative period; to determine the impact of the preoperative pulmonary rehabilitation program on performance on the TGlittre; to determine the impact of the postoperative PR program on TGlittre performance; and to evaluate the incidence of postoperative complications and length of stay, considering the performance in TGlittre and the performance in the PR program. Using block randomization, participants who meet the inclusion criteria will be randomly assigned to one of 2 groups: 1) Intervention Group: Pulmonary Rehabilitation; and 2) Control Group: Standard Care. PR will be performed pre- and postoperatively, lasting 4 and 12 weeks, respectively. These participants will submit to the following tests: International Physical Activity Questionnaire; St. George's Respiratory Questionnaire; lung function (spirometry, measurement of lung diffusion capacity to carbon monoxide and measurement of respiratory muscle strength); handgrip strength; quadriceps strength; and TGlittre. The aim of this study is to support the applicability of TGlittre as an evaluative strategy for pulmonary rehabilitation in the pre- and postoperative periods of patients with non-small cell lung cancer, and also to verify the impact of pre- and postoperative rehabilitation strategies on quality of life, morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The sample will be divided into two groups: Intervention Group and Control Group. Patients meeting the inclusion criteria will be randomly assigned to one of 2 groups (GI and CG) in a 1:1 ratio using a computer-generated random allocation sequence using the stratified block randomization method of SAS version 9.1. 3 (SAS Institute, Cary, NC, USA). Randomization will be performed by an independent research assistant who will not participate in any other phase of this study. The health professionals who will work in the study (physicians and physiotherapists) will be informed of the assignment of the treatment by telephone confirmation. The evaluators of clinical and statistical results will be "blinded" to the randomization, since it was not feasible to "blind" the other professionals involved in the research.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NSCLC stages I to IV, that is, those patients without evidence of mediastinal disease or local organ invasion.
- •Age equal to or greater than 18 years.
- •The following types of lung surgery: pneumonectomy, bilobectomy, lobectomy, segmentectomy and wedge resection.
- •Resection by thoracotomy or video-assisted thoracoscopic surgery.
排除标准
- •Patients known to need adjuvant treatments.
- •Show inability to walk.
- •Not being able to perform pulmonary function tests and/or functional tests.
- •Presence of cardiovascular, neurological or orthopedic diseases.
- •Bronchopleural fistula, sudden increase in chest drainage or active intrathoracic hemorrhage, chylothorax or other serious adverse events.
研究组 & 干预措施
Health education and home care
They will receive standard care: a therapeutic education session on admission, plus daily in-house early postoperative rehabilitation, delivered by a physiotherapist. The therapeutic educational session will involve counseling and self-care management, aiming to prepare patients for the postoperative period, emphasizing breathing exercises and sputum clearance techniques, pain control strategies and self-care. It will consist of smoking cessation education, respiratory retraining (pursed-lip breathing, diaphragmatic breathing, and segmental breathing), and secretion clearance training (coughing exercise, huffing, assisted coughing, and postural drainage).
Pulmonary rehabilitation
They will receive standard care described (AP) plus perioperative PR, with 20 preoperative and 60 postoperative sessions. The preoperative sessions will be held 2X/week, in addition to the home sessions 3X/week. Each outpatient session will last 2 hours and will consist of therapeutic education, aerobic exercises, resistance training of lower limbs, upper limbs and abdominal wall, and respiratory muscle training (RMT), which will include breathing pattern, positive expiratory pressure and inspiratory muscles training and home will last for 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at an intensity of 60-80% of maximum HR. Participants will receive a portable pedometer and HR monitor. Postoperative rehabilitation will be offered only to the IG, from 1 month after surgery, with 60 sessions divided into 24 outpatient sessions performed 2X/week and 36 home sessions 3X/week. The postoperative program will last 12 weeks.
干预措施: ADL-Glittre Test (Other)
结局指标
主要结局
Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test).
时间窗: six months
The participant must complete 5 laps in the shortest possible time. The test consists of carrying a backpack containing a 2.5kg weight completing a circuit with the following activities. The participant rises from a seated position and walks on a 10-m flat course, interposed halfway by a stairway with 2 steps to ascend and 2 to descend. After completing the course, the individual approaches a 2-teir shelf containing 3 objects weighing 1kg each, placed on the highest shelf (shoulder height), that must be moved 1 by 1 to the bottom shelf (waist height) and then down to the floor. Then, the objects are placed on the bottom shelf again and finally on the top shelf. Then, the individual turns and walks back over the course; immediately after completion of 1 lap, another lap is started, completing the same circuit. The instructions are standardized, and there is no incentive during the test. Two tests are performed with a minim.
次要结局
- St. George's Respiratory Questionnaire (SGRQ)(six months)
- Handgrip strength (HGS)(six months)
- International Physical Activity Questionnaire (IPAQ)(six months)
- Spirometry- forced expiratory volume in one second (FEV1)(six months)
- Respiratory muscle strength(Six months)
- Spirometry- Forced Vital Capacity (FVC)(six months)
- Quadriceps strength(six months)
- Spirometry- Peak Expiratory Flow (PEF)(six months)
- Carbon monoxide diffusion capacity (DLCO)(Six months)