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Lung Cancer, Nonsmall CellNCT05863013

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

A study testing ADL-Glittre Test in people with Lung Cancer, Nonsmall Cell and Quality of Life, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ADL-Glittre Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteBrazil
Study dates
13 Jun 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro Universitário Augusto Motta

    Rio de Janeiro, 22745271

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
ADL-Glittre Test
Keywords
ADL-Glittre test, Functional capacity, pulmonary rehabilitation, Lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADL-Glittre TestOther

    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.

Study groups in NCT05863013
Study groupRoleWhat they receive
Health education and home careNo interventionThey 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 rehabilitationExperimentalThey 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.
Receives: Other: ADL-Glittre Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: six months

Secondary outcomes (9)

  1. International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire (IPAQ) contains seven open questions and aims to quantify the weekly time spent in physical activities of moderate and vigorous intensity, in different everyday contexts, such as work, transportation, household chores and leisure, and also the time spent in passive activities performed in a sitting position. To answer the questions, participants will be instructed to consider the week before the IPAQ application date and will subsequently be classified according to the level of activity as sedentary, irregularly active, active or very active, according to the weekly frequency and duration of activities performed.

    Measured: six months

  2. St. George's Respiratory Questionnaire (SGRQ)

    To measure quality of life, the Saint George Hospital questionnaire on respiratory disease was applied, which was validated and adapted for the Brazilian population. This instrument covers aspects in three domains, which are: symptoms, activity and psychosocial impacts that the disease can influence in their daily routine. The answers translate into points that, once added together, can infer about an altered Quality of life in a given domain. A score is calculated for each domain (0-100 points) and a total score is also calculated, the higher the score, the worse the measured quality of life.

    Measured: six months

  3. Handgrip strength (HGS)

    HGS will be measured in kilograms using a handheld digital dynamometer (SH5001, Saehan Corporation, Korea). The HGS will be evaluated with the participants sitting in a chair without arms, with elbow flexion at 90°, forearms in a neutral position and extension wrist angle between 0 and 30°. The maximum force will be evaluated after sustained contraction of 3s in the dominant hand; the highest value of 3 attempts with 1 min intervals will be considered for analysis.

    Measured: six months

  4. Quadriceps strength

    Quadriceps strength will be assessed using a traction dynamometer with a sensor capacity of 200 kg (E-lastic 5.0, E-sport SE, Brazil). The amplitude of movement in the execution of the test will be determined in 90°, starting from 90° with the knee in flexion. Maximum strength will be evaluated after a sustained contraction of 5 s on the dominant leg, and the highest value from 3 attempts with 1-min intervals will be considered for analysis.

    Measured: six months

  5. Spirometry- forced expiratory volume in one second (FEV1)

    During the spirometry test, the individual must remain seated, with the head in a neutral position to avoid changes in expiratory flows. The evaluator must advise that the maneuvers are performed through encouragement and verbal stimulation. The procedure must be guided and demonstrated by the technician, through a tube. It is necessary for the patient to perform a maximum inspiration, followed by a rapid and sustained expiration. The measure of forced expiratory volume in one second (FEV1) will be evaluated, which is the amount of air eliminated in the first second of the forced expiratory maneuver.

    Measured: six months

  6. Spirometry- Forced Vital Capacity (FVC)

    During the spirometry test, the measurement of forced vital capacity (FVC) will also be evaluated, which can be identified through the volume eliminated in the forced expiratory maneuver from total lung capacity to residual volume.

    Measured: six months

  7. Spirometry- Peak Expiratory Flow (PEF)

    During the spirometry test, the peak expiratory flow (PEF) will also be evaluated, which represents the maximum air flow during the FVC maneuver. PEF is an effort-dependent expiratory parameter that reflects the caliber of the proximal airways and is often used as an effective cough marker.

    Measured: six months

  8. Carbon monoxide diffusion capacity (DLCO)

    For the DLCO analysis, the use of a nose clip will be requested (in order to avoid nasal breathing), remaining in a sitting position and coupling to the pulmonary function device through an appropriate mouthpiece. After slow expiration to residual volume, rapid but not forced inspiration will be performed. Upon reaching full lung capacity, an inspiratory pause of approximately 10s will occur and then the inhaled gas will be exhaled smoothly and without interruptions. The expired air volume will be collected for analysis that will determine the difference between inspired CO and expired CO (diffused CO).

    Measured: Six months

  9. Respiratory muscle strength

    For analysis of respiratory muscle strength, measurements of inspiratory pressure and maximum expiratory pressure will be recorded. The individual must remain in a sitting position, with the head in a neutral position and is asked to perform a maximum expiration, that is, up to the residual volume, to measure the inspiratory pressure. Next, the patient makes a maximal inspiratory effort against the occluded airway. To verify the expiratory pressure, the patient is instructed to perform a maximum inspiration up to the level of total lung capacity, then, they must perform a maximum expiratory effort against the occluded airway. The maximum value of three maneuvers that varied less than 20%, the variability within the measurements, the predicted value, and the lower limit of normality range will be recorded. National equations will be adopted to calculate the predicted values of each participant.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start13 Jun 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863013
Sponsor's protocol ID
67676823.4.0000.5259
Status last verified
May 2024
First submitted
25 Mar 2023
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29715115

  • 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.

    PubMed 12091180

  • 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.

    PubMed 26538411

  • 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.

    PubMed 29538545

  • 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.

    PubMed 26241869

  • 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.

    PubMed 34275888

  • 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.

    PubMed 32651199

  • 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.

    PubMed 23959742

  • 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.

    PubMed 34086348

  • 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.

    PubMed 11209097

  • 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.

    PubMed 17218568

  • 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.

    PubMed 18520258

  • 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.

    PubMed 23649437

  • 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.

    PubMed 28244801

  • 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.

    PubMed 21276720

Questions about this trial

What is this clinical trial studying?

A study testing ADL-Glittre Test in people with Lung Cancer, Nonsmall Cell and Quality of Life, run by Centro Universitário Augusto Motta at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test). (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863013, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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