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| Name | Class |
|---|---|
| Rio de Janeiro State University | OTHER |
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Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique.
Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique. This is a randomized controlled trial, in which the sample will be divided into two groups: intervention for 12 weeks with PR and standard care. Functional capacity will be evaluated pre- and post-PR through the Glittre-ADL test with incorporation of dynamic ventilation, lung function (including impulse oscillometry), respiratory and peripheral muscle function, general fatigue and HRQoL. It is expected that PTB-PD patients will benefit significantly and, therefore, be able to (re)enter society, especially in job market.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants will receive standard care (SC) |
|
| Intervention | Experimental | Participants will receive the standard care (SC) plus pulmonary rehabilitation (PR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care plus pulmonary rehabilitation | Other | A 12-week rehabilitation program, 3X/week. Each outpatient session will last 2 hours including: guidance on the care of inhalation techniques and/or oxygen therapy, when prescribed; aerobic training on a cycle ergometer supervised by a physiotherapist (30 min each: 5 min warm-up, 20 min training and 5 min cool-down) at constant load calculated with Hill's equation (HILL et al., 2008). Optional components of RP will include: inspiratory muscle conditioning using a threshold-loading device, inspiratory muscle training with powerbreathe, breathing exercises, airway clearance, psychological support, relaxation and nutritional counseling. Patients will participate in two group educational sessions, managed by a respiratory physiotherapist, on lifestyle, physical activity and maintenance programs (VISCA et al., 2019; FUGAZZARO et al., 2017; TENCONI et al., 2021). |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program | Executed as proposed by Skumlien et al. (2006). The shorter duration TGlittre will be used for analysis and comparison to predicted values for healthy brazilians (REIS et al., 2018). Furthermore, the device Spiropalm 6MWT, Cosmed, Rome, Italy, will be attached to the patient. Inspiratory capacity (IC) will be obtained before and after TGlittre, and a ≥100 mL decrease in IC (∆IC) during exertion will be defined as dynamic hyperinflation (TOSUN et al., 2022). Other dynamic ventilatory responses assessed: minute ventilation (VE) and ventilatory reserve (RV). The latter indicates how close VE comes to maximum ventilation during a given activity, and will be calculated as the difference between maximum voluntary ventilation (MVV) and VEpeak ([MVV - VEpeak]/VVM); VR <30% will be considered exertional ventilation limitation (LOPES et al., 2011a). The MVV will be automatically determined by the device as 40 multiplied by FEV1 | an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical-functional assessment | Clinical examination and anthropometric measurements | an average of 4 years |
| Saint George's Respiratory Questionnaire (SGRQ) | To measure health-related quality of life (HRQOL), the SGRQ will be applied, which was previously validated and adapted for the Brazilian population (DE SOUSA et al., 2000). This instrument covers aspects in 3 domains, which are: symptoms, activity and psychosocial impacts that the disease can influence on your daily routine. The answers translate into points that, once added together, can infer an altered HRQoL in a given domain. |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnaldo José Lopes, DsC | Contact | +55 21998536162 | agnaldolopes.uerj@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agnaldo José Lopes | Recruiting | Rio de Janeiro | 22745-271 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23743314 | Background | Aggarwal AN, Gupta D, Janmeja AK, Jindal SK. Assessment of health-related quality of life in patients with pulmonary tuberculosis under programme conditions. Int J Tuberc Lung Dis. 2013 Jul;17(7):947-53. doi: 10.5588/ijtld.12.0299. | |
| 32912387 | Background | Allwood BW, van der Zalm MM, Amaral AFS, Byrne A, Datta S, Egere U, Evans CA, Evans D, Gray DM, Hoddinott G, Ivanova O, Jones R, Makanda G, Marx FM, Meghji J, Mpagama S, Pasipanodya JG, Rachow A, Schoeman I, Shaw J, Stek C, van Kampen S, von Delft D, Walker NF, Wallis RS, Mortimer K. Post-tuberculosis lung health: perspectives from the First International Symposium. Int J Tuberc Lung Dis. 2020 Aug 1;24(8):820-828. doi: 10.5588/ijtld.20.0067. |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized Clinical Trial
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|
| Standard Care | Other | Participants will receive standard care (SC): a therapeutic education session upon admission, as well as pulmonary rehabilitation (PR) taught by a physical therapist. This therapeutic educational session will involve counseling and self-care management, emphasizing breathing exercises and sputum clearance and self-care techniques. It will consist of smoking cessation education (if this is the case, as tobacco is associated with TB), respiratory retraining (pursed lip breathing, diaphragmatic breathing and segmental breathing) and secretion removal training (coughing exercise, huffing , assisted cough and postural drainage). |
|
| an average of 4 years |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | The FACIT-F was translated into Portuguese by the FACIT.ORG group. It is a 13-item scale that aims to assess the individual's general fatigue correlated to their daily activities. These items provide a score ranging from 0 to 52. The lower the score, the lower the fatigue index. A score greater than 30 indicates severe fatigue. Clinically, an increase of 3 to 4 points in FACIT-F is considered an important difference (MIYAMOTO, 2016; LIMA et al., 2019). | an average of 4 years |
| Pulmonary function measurements | Pulmonary function using an HDpft 3000 device (nSpire Health, Inc., Longmont, CO, USA). Spirometry, body plethysmography, carbon monoxide diffusion (DLCO) measurement and respiratory muscle strength measurement will be performed. | an average of 4 years |
| Handgrip strength (HGS) | HGS will be measured in kilograms using a digital dynamometer (SH5001, Saehan Corporation, Korea). HGS will be assessed with participants sitting in an armless chair, with elbow flexion at 90°, forearms in a neutral position and wrist extension between 0 and 30° (NONATO et al., 2020). Maximum strength will be assessed after a sustained contraction of 3 s in the dominant hand; the highest value of 3 attempts with 1 min intervals will be considered for analysis (ASSIS et al., 2022) | an average of 4 years |
| Quadriceps strength (QS) | QS will be evaluated using a traction dynamometer with a sensor capacity of 200 kg (E-lastic 5.0, E-sporte SE, Brazil). The range of movement when performing the test will be determined at 90°, starting from 90° with the knee in flexion. Maximum strength will be assessed after a sustained contraction of 5 s in the dominant leg, with the highest value of 3 attempts at 1 min intervals being considered for analysis (ASSIS et al., 2022). | an average of 4 years |
| Centro Universitario Augusto Motta | Recruiting | Rio de Janeiro | 22745271 | Brazil |
|
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| 35584466 | Background | Silva DR, Freitas AA, Guimaraes AR, D'Ambrosio L, Centis R, Munoz-Torrico M, Visca D, Migliori GB. Post-tuberculosis lung disease: a comparison of Brazilian, Italian, and Mexican cohorts. J Bras Pneumol. 2022 May 13;48(2):e20210515. doi: 10.36416/1806-3756/e20210515. eCollection 2022. |
| 19009210 | Background | Silva DR, Gazzana MB, Barreto SS, Knorst MM. Idiopathic pulmonary fibrosis and emphysema in smokers. J Bras Pneumol. 2008 Oct;34(10):779-86. doi: 10.1590/s1806-37132008001000005. English, Portuguese. |
| 15941658 | Background | Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6. |
| 34042410 | Background | Tenconi S, Mainini C, Rapicetta C, Braglia L, Galeone C, Cavuto S, Merlo DF, Costi S, Paci M, Piro R, Fugazzaro S. Rehabilitation for lung cancer patients undergoing surgery: results of the PUREAIR randomized trial. Eur J Phys Rehabil Med. 2021 Dec;57(6):1002-1011. doi: 10.23736/S1973-9087.21.06789-7. Epub 2021 May 27. |
| 35666051 | Background | Caglar Tosun BN, Zeren M, Barlik M, Demir E, Gulen F. Investigation of dynamic hyperinflation and its relationship with exercise capacity in children with bronchiectasis. Pediatr Pulmonol. 2022 Sep;57(9):2218-2226. doi: 10.1002/ppul.26028. Epub 2022 Jun 14. |
| 30844519 | Background | Vashakidze SA, Kempker JA, Jakobia NA, Gogishvili SG, Nikolaishvili KA, Goginashvili LM, Magee MJ, Kempker RR. Pulmonary function and respiratory health after successful treatment of drug-resistant tuberculosis. Int J Infect Dis. 2019 May;82:66-72. doi: 10.1016/j.ijid.2019.02.039. Epub 2019 Mar 5. |
| 32912378 | Background | Visca D, Centis R, Munoz-Torrico M, Pontali E. Post-tuberculosis sequelae: the need to look beyond treatment outcome. Int J Tuberc Lung Dis. 2020 Aug 1;24(8):761-762. doi: 10.5588/ijtld.20.0488. No abstract available. |
| 30872556 | Background | Visca D, Zampogna E, Sotgiu G, Centis R, Saderi L, D'Ambrosio L, Pegoraro V, Pignatti P, Munoz-Torrico M, Migliori GB, Spanevello A. Pulmonary rehabilitation is effective in patients with tuberculosis pulmonary sequelae. Eur Respir J. 2019 Mar 14;53(3):1802184. doi: 10.1183/13993003.02184-2018. Print 2019 Mar. No abstract available. |
| 32082283 | Background | Wang J, Xiong K, Zhao S, Zhang C, Zhang J, Xu L, Ma A. Long-Term Effects of Multi-Drug-Resistant Tuberculosis Treatment on Gut Microbiota and Its Health Consequences. Front Microbiol. 2020 Jan 30;11:53. doi: 10.3389/fmicb.2020.00053. eCollection 2020. |
| Background | World Health Organization. Global tuberculosis report 2021]. Geneva: WHO; 2021. Global Tuberculosis Report 2021. Disponível em: https://www.who.int/publications/i/item/9789240037021. |
| Background | World Health Organization. Global Tuberculosis Report 2022. Geneva: WHO; c2022. Disponível em: https://www.who.int/teams/global-tuberculosis-programme/tbreports/global-tuberculosis-report-2022. |
| 41035122 | Derived | Souza AMLR, Silva DLOD, Silva MMD, Silva LLD, Silva UDPVD, Beserra ADS, Freitas YO, Ferreira IDN, Lopes AJ. Peripheral Muscle Strength and Pulmonary Function Negatively Impact Functional Capacity in Patients With Post-Tuberculosis Lung Disease: A Cross-Sectional Study. Physiother Res Int. 2025 Oct;30(4):e70115. doi: 10.1002/pri.70115. |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |