Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer

Trial Title: Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer

NCT ID: NCT05863013

Condition: Lung Cancer, Nonsmall Cell
Quality of Life
Physical Disability
Surgery

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
ADL-Glittre test
Functional capacity
pulmonary rehabilitation
Lung cancer

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients included in the study will be evaluated: T0 (baseline): Baseline assessments will be performed immediately prior to randomization and will include lung function [spirometry, measurement of pulmonary CO2 diffusing capacity (DLCO) and measurement of respiratory muscle strength], handgrip measurement , measurement of quadriceps strength (HR ), exercise capacity (TGlittre1), level of physical activity in daily life (International Physical Activity Questionnaire - IPAQ) and assessment of QoL (St. George's Respiratory Questionnaire - SGRQ). T1 (day before surgery): Patients will repeat lung function, HGS measurement, HR measurement, TGlittre2, IPAQ, and SGRQ. T2 (1 month after surgery): Patients will repeat the tests from the previous phase. Data on postoperative complications and 30-day complications and mortality will also be recorded. T3 (4 months after surgery): Patients will have repeat lung function, HGS measurement, HR measurement, TGlittre4, IPAQ, and SGRQ.

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Other
Intervention name: ADL-Glittre Test
Description: They will receive standard care described plus perioperative pulmonary rehabilitation, with 20 preoperative sessions and 60 postoperative sessions. Preoperative sessions will be held 2X/week, in addition to 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 training of inspiratory and respiratory muscles. home will last 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at 60-80% of maximum HR intensity. 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.
Arm group label: Pulmonary rehabilitation

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centro Universitário Augusto Motta

Address:
City: Rio De Janeiro
Zip: 22745271
Country: Brazil

Start date: June 13, 2023

Completion date: December 2024

Lead sponsor:
Agency: Centro Universitário Augusto Motta
Agency class: Other

Source: Centro Universitário Augusto Motta

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05863013