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

NCT05863013 | Enrolling By Invitation DMC

• 1 other identifier: 67676823.4.0000.5259
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ADL-Glittre test; Functional capacity; pulmonary rehabilitation; Lung cancer

Outcome Measures

Primary Outcomes (1)

• Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test).

  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.

  six months

Secondary Outcomes (9)

• International Physical Activity Questionnaire (IPAQ)

  six months

• St. George's Respiratory Questionnaire (SGRQ)

  six months

• Handgrip strength (HGS)

  six months

• Quadriceps strength

  six months

• Spirometry- forced expiratory volume in one second (FEV1)

  six months

Study Arms (2)

Health education and home care

NO INTERVENTION

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

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.

Other: ADL-Glittre Test

Interventions

ADL-Glittre Test OTHER

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.

Pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, 22745271, Brazil

Location

Related Publications (27)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: May 17, 2023
• Study Start: June 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)