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

Centro Universitário Augusto Motta

Status: Invitation-only

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

Treatments: Other: ADL-Glittre Test

Study type: Interventional

Funder types: Other

Identifiers

NCT05863013

67676823.4.0000.5259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Health education and home care

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Other: ADL-Glittre Test