Clinical trial NCT05863013: Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Cancer, Nonsmall Cell
Quality of Life
Physical Disability
Surgery
Keywords: ADL-Glittre test
Functional capacity
pulmonary rehabilitation
Lung cancer
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

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.

Primary outcomes:
measure: Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test).
timeFrame: six months
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: six months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: six months
measure: Handgrip strength (HGS)
timeFrame: six months
measure: Quadriceps strength
timeFrame: six months
measure: Spirometry- forced expiratory volume in one second (FEV1)
timeFrame: six months
measure: Spirometry- Forced Vital Capacity (FVC)
timeFrame: six months
measure: Spirometry- Peak Expiratory Flow (PEF)
timeFrame: six months
measure: Carbon monoxide diffusion capacity (DLCO)
timeFrame: Six months
measure: Respiratory muscle strength
timeFrame: Six months
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Centro Universitário Augusto Motta
Study officials:
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