Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863013
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2023-03-25
Brief Title:
Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer
Sponsor:
Centro Universitário Augusto Motta
Organization:
Centro Universitário Augusto Motta
Study Overview
Official Title:
Longitudinal Changes in the ADL-Glittre Test in Patients With Lung Cancer Pre- and Postoperative Analysis Using Rehabilitation in a Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Georges 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None