Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer
NCT ID: NCT05863013
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2023-06-13
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lung Resection and Pulmonary Rehabilitation
NCT04722393
Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection
NCT06202222
Prehabilitation for Lung Cancer Patients Undergoing Lung Resection
NCT06802627
QOL After SURGERY and ADJUVANT Treatment
NCT06115239
Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
NCT03824977
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Health education and home care
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).
No interventions assigned to this group
Pulmonary rehabilitation
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.
ADL-Glittre Test
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ADL-Glittre Test
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro Universitário Augusto Motta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro Universitário Augusto Motta
Rio de Janeiro, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
de Alegria SG, Kasuki L, Gadelha M, Lopes AJ. The Glittre Activities of Daily Living Test in patients with acromegaly: Associations with hand function and health-related quality of life. J Back Musculoskelet Rehabil. 2021;34(3):441-451. doi: 10.3233/BMR-200089.
de Groot PM, Wu CC, Carter BW, Munden RF. The epidemiology of lung cancer. Transl Lung Cancer Res. 2018 Jun;7(3):220-233. doi: 10.21037/tlcr.2018.05.06.
de Oliveira Vacchi C, Martha BA, Macagnan FE. Effect of inspiratory muscle training associated or not to physical rehabilitation in preoperative anatomic pulmonary resection: a systematic review and meta-analysis. Support Care Cancer. 2022 Feb;30(2):1079-1092. doi: 10.1007/s00520-021-06467-4. Epub 2021 Aug 21.
Fugazzaro S, Costi S, Mainini C, Kopliku B, Rapicetta C, Piro R, Bardelli R, Rebelo PFS, Galeone C, Sgarbi G, Lococo F, Paci M, Ricchetti T, Cavuto S, Merlo DF, Tenconi S. PUREAIR protocol: randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer. BMC Cancer. 2017 Jul 31;17(1):508. doi: 10.1186/s12885-017-3479-y.
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
Goldsmith I, Chesterfield-Thomas G, Toghill H. Pre-treatment optimization with pulmonary rehabilitation in lung cancer: Making the inoperable patients operable. EClinicalMedicine. 2020 Nov 30;31:100663. doi: 10.1016/j.eclinm.2020.100663. eCollection 2021 Jan.
Graham BL, Brusasco V, Burgos F, Cooper BG, Jensen R, Kendrick A, MacIntyre NR, Thompson BR, Wanger J. 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung. Eur Respir J. 2017 Jan 3;49(1):1600016. doi: 10.1183/13993003.00016-2016. Print 2017 Jan.
Hirpara DH, Kidane B, Rogalla P, Cypel M, de Perrot M, Keshavjee S, Pierre A, Waddell T, Yasufuku K, Darling GE. Frailty assessment prior to thoracic surgery for lung or esophageal cancer: a feasibility study. Support Care Cancer. 2019 Apr;27(4):1535-1540. doi: 10.1007/s00520-018-4547-9. Epub 2018 Nov 14.
Almquist D, Khanal N, Smith L, Ganti AK. Preoperative Pulmonary Function Tests (PFTs) and Outcomes from Resected Early Stage Non-small Cell Lung Cancer (NSCLC). Anticancer Res. 2018 May;38(5):2903-2907. doi: 10.21873/anticanres.12537.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
de Araujo CL, Karloh M, Dos Reis CM, Palu M, Mayer AF. Pursed-lips breathing reduces dynamic hyperinflation induced by activities of daily living test in patients with chronic obstructive pulmonary disease: A randomized cross-over study. J Rehabil Med. 2015 Nov;47(10):957-62. doi: 10.2340/16501977-2008.
Araujo LH, Baldotto C, Castro G Jr, Katz A, Ferreira CG, Mathias C, Mascarenhas E, Lopes GL, Carvalho H, Tabacof J, Martinez-Mesa J, Viana LS, Cruz MS, Zukin M, Marchi P, Terra RM, Ribeiro RA, Lima VCC, Werutsky G, Barrios CH; Grupo Brasileiro de Oncologia Toracica. Lung cancer in Brazil. J Bras Pneumol. 2018 Jan-Feb;44(1):55-64. doi: 10.1590/S1806-37562017000000135.
Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, Savci S, Inal-Ince D, Ozcelik U, Kiper N. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and healthy subjects. Res Dev Disabil. 2015 Oct-Nov;45-46:147-56. doi: 10.1016/j.ridd.2015.07.020. Epub 2015 Aug 1.
Assis ACB, Lopes AJ. Functional exercise capacity in rheumatoid arthritis unrelated to lung injury: A comparison of women with and without rheumatoid disease. J Back Musculoskelet Rehabil. 2022;35(2):449-458. doi: 10.3233/BMR-210056.
Boujibar F, Gillibert A, Gravier FE, Gillot T, Bonnevie T, Cuvelier A, Baste JM. Performance at stair-climbing test is associated with postoperative complications after lung resection: a systematic review and meta-analysis. Thorax. 2020 Sep;75(9):791-797. doi: 10.1136/thoraxjnl-2019-214019. Epub 2020 Jul 10.
Bradley A, Marshall A, Stonehewer L, Reaper L, Parker K, Bevan-Smith E, Jordan C, Gillies J, Agostini P, Bishay E, Kalkat M, Steyn R, Rajesh P, Dunn J, Naidu B. Pulmonary rehabilitation programme for patients undergoing curative lung cancer surgery. Eur J Cardiothorac Surg. 2013 Oct;44(4):e266-71. doi: 10.1093/ejcts/ezt381. Epub 2013 Aug 19.
Bray F, Laversanne M, Weiderpass E, Soerjomataram I. The ever-increasing importance of cancer as a leading cause of premature death worldwide. Cancer. 2021 Aug 15;127(16):3029-3030. doi: 10.1002/cncr.33587. Epub 2021 Jun 4.
British Thoracic Society; Society of Cardiothoracic Surgeons of Great Britain and Ireland Working Party. BTS guidelines: guidelines on the selection of patients with lung cancer for surgery. Thorax. 2001 Feb;56(2):89-108. doi: 10.1136/thorax.56.2.89. No abstract available.
Brunelli A, Xiume F, Refai M, Salati M, Marasco R, Sciarra V, Sabbatini A. Evaluation of expiratory volume, diffusion capacity, and exercise tolerance following major lung resection: a prospective follow-up analysis. Chest. 2007 Jan;131(1):141-7. doi: 10.1378/chest.06-1345.
Brunelli A, Salati M. Preoperative evaluation of lung cancer: predicting the impact of surgery on physiology and quality of life. Curr Opin Pulm Med. 2008 Jul;14(4):275-81. doi: 10.1097/MCP.0b013e328300caac.
Brunelli A, Kim AW, Berger KI, Addrizzo-Harris DJ. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e166S-e190S. doi: 10.1378/chest.12-2395.
Bui KL, Nyberg A, Maltais F, Saey D. Functional Tests in Chronic Obstructive Pulmonary Disease, Part 2: Measurement Properties. Ann Am Thorac Soc. 2017 May;14(5):785-794. doi: 10.1513/AnnalsATS.201609-734AS.
Cavalheri V, Donaria L, Ferreira T, Finatti M, Camillo CA, Cipulo Ramos EM, Pitta F. Energy expenditure during daily activities as measured by two motion sensors in patients with COPD. Respir Med. 2011 Jun;105(6):922-9. doi: 10.1016/j.rmed.2011.01.004. Epub 2011 Jan 28.
Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
Choi J, Yang Z, Lee J, Lee JH, Kim HK, Yong HS, Lee SY. Usefulness of Pulmonary Rehabilitation in Non-Small Cell Lung Cancer Patients Based on Pulmonary Function Tests and Muscle Analysis Using Computed Tomography Images. Cancer Res Treat. 2022 Jul;54(3):793-802. doi: 10.4143/crt.2021.769. Epub 2021 Oct 20.
Colice GL, Shafazand S, Griffin JP, Keenan R, Bolliger CT; American College of Chest Physicians. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):161S-77S. doi: 10.1378/chest.07-1359.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
67676823.4.0000.5259
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.