Pulmonary TuberculosisNCT06127641
Rehabilitation of People With Post-tuberculosis Lung Disease
A study of Pulmonary Tuberculosis, run by Centro Universitário Augusto Motta at 2 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 28 Oct 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with post-tuberculosis lung disease, clinically stable and able to perform >80% of training sessions.
Who cannot join
- Presence of comorbidities not related to PD-PTB.
- Patients with inability to perform TGlittre.
- Patients who have cognitive changes that impair their inclusion in the study.
- Treatment abandonment during the application of the PR protocol.
- Uncontrolled hypertension or use of psychotropic medications.
- Any significant limitations due to osteoarthropathy.
- Having had any orthopedic surgery in the previous year.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Agnaldo José Lopes
Rio de Janeiro, 22745-271
Agnaldo J Lopes, PhD, 2125762030, agnaldolopes.uerj@gmail.com
- Recruiting
Centro Universitario Augusto Motta
Rio de Janeiro, 22745271
Agnaldo Lopes, PhD, 21998536162, agnaldolopes.uerj@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Standard care plus pulmonary rehabilitation, Standard Care
- Keywords
- Pulmonary tuberculosis, Tuberculosis sequelae, Rehabilitation, ADL-Glittre test, Functionality, Quality of life
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care plus pulmonary rehabilitationOther
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).
Standard CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will receive standard care (SC) Receives: Other: Standard Care |
| Intervention | Experimental | Participants will receive the standard care (SC) plus pulmonary rehabilitation (PR) Receives: Other: Standard care plus pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: an average of 4 years
Secondary outcomes (6)
Clinical-functional assessment
Clinical examination and anthropometric measurements
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127641
- Sponsor's protocol ID
- 70493823.5.0000.5259
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23743314Allwood 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.
PubMed 32912387Allwood BW, Maasdorp E, Kim GJ, Cooper CB, Goldin J, van Zyl-Smit RN, Bateman ED, Dawson R. Transition from Restrictive to Obstructive Lung Function Impairment During Treatment and Follow-Up of Active Tuberculosis. Int J Chron Obstruct Pulmon Dis. 2020 May 11;15:1039-1047. doi: 10.2147/COPD.S219731. eCollection 2020.
PubMed 32494129Amaral AF, Coton S, Kato B, Tan WC, Studnicka M, Janson C, Gislason T, Mannino D, Bateman ED, Buist S, Burney PG; BOLD Collaborative Research Group. Tuberculosis associates with both airflow obstruction and low lung function: BOLD results. Eur Respir J. 2015 Oct;46(4):1104-12. doi: 10.1183/13993003.02325-2014. Epub 2015 Jun 25.
PubMed 26113680Banu Rekha VV, Ramachandran R, Kuppu Rao KV, Rahman F, Adhilakshmi AR, Kalaiselvi D, Murugesan P, Sundaram V, Narayanan PR. Assessment of long term status of sputum positive pulmonary TB patients successfully treated with short course chemotherapy. Indian J Tuberc. 2009 Jul;56(3):132-40.
PubMed 20349754Bogossian M, Santoro IL, Jamnik S, Romaldini H. Bronchiectasis: a study of 314 cases tuberculosis x nontuberculosis. J Bra Pneumol. 1998; 24(1): 11-6.
Brasil. Ministério da Saúde. Manual de Recomendações para o Controle da Tuberculose no Brasil 2019. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/manual_recomendacoes_controle_tuberculose_brasil_2_ed.pdf
Butzko RP, Sotolongo AM, Helmer DA, Klein-Adams JC, Osinubi OY, Berman AR, Ortiz-Pacheco R, Falvo MJ. Forced oscillation technique in veterans with preserved spirometry and chronic respiratory symptoms. Respir Physiol Neurobiol. 2019 Feb;260:8-16. doi: 10.1016/j.resp.2018.11.012. Epub 2018 Nov 30.
PubMed 30508589Byrne AL, Marais BJ, Mitnick CD, Lecca L, Marks GB. Tuberculosis and chronic respiratory disease: a systematic review. Int J Infect Dis. 2015 Mar;32:138-46. doi: 10.1016/j.ijid.2014.12.016.
PubMed 25809770Chin AT, Rylance J, Makumbirofa S, Meffert S, Vu T, Clayton J, Mason P, Woodruff P, Metcalfe J. Chronic lung disease in adult recurrent tuberculosis survivors in Zimbabwe: a cohort study. Int J Tuberc Lung Dis. 2019 Feb 1;23(2):203-211. doi: 10.5588/ijtld.18.0313.
PubMed 30808453Daniels KJ, Irusen E, Pharaoh H, Hanekom S. Post-tuberculosis health-related quality of life, lung function and exercise capacity in a cured pulmonary tuberculosis population in the Breede Valley District, South Africa. S Afr J Physiother. 2019 Jul 31;75(1):1319. doi: 10.4102/sajp.v75i1.1319. eCollection 2019.
PubMed 31392293De Sousa TC, Jardim JR, Jones P. Validation of the Saint George's Respiratory Questionnaire in patients with chronic obstructive pulmonary disease in Brazil. J Pneumologia 2000; 26(3): 119-128.
Dias VL, Canan MGM, Leitao CA, Okuno EA, de Sant'Ana GRD, Miranda JV. Profile of patients with post-tuberculosis bronchiectasis in a tertiary care hospital in Brazil. J Clin Tuberc Other Mycobact Dis. 2022 Nov 13;29:100339. doi: 10.1016/j.jctube.2022.100339. eCollection 2022 Dec.
PubMed 36405996Ehrlich RI, White N, Norman R, Laubscher R, Steyn K, Lombard C, Bradshaw D. Predictors of chronic bronchitis in South African adults. Int J Tuberc Lung Dis. 2004 Mar;8(3):369-76.
PubMed 15139477Evans D. Socio-economic consequences and quality adjusted life years associated with post-TB sequelae. Int J Tuberc Lung Dis. 2021; 25(Suppl 2): S21.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of People With Post-tuberculosis Lung Disease
- ClinicalTrials.gov ID
- NCT06127641
- Acronym / sponsor ID
- 70493823.5.0000.5259
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary tuberculosis, Tuberculosis sequelae, Rehabilitation, ADL-Glittre test, Functionality, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard CareParticipants will receive standard care (SC) |
| Intervention | Experimental | Other: Standard care plus pulmonary rehabilitationParticipants will receive the standard care (SC) plus pulmonary rehabilitation (PR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with post-tuberculosis lung disease, clinically stable and able to perform >80% of training sessions.
Key exclusion criteria (7 listed)
- Presence of comorbidities not related to PD-PTB.
- Patients with inability to perform TGlittre.
- Patients who have cognitive changes that impair their inclusion in the study.
- Treatment abandonment during the application of the PR protocol.
- Uncontrolled hypertension or use of psychotropic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care plus pulmonary rehabilitationA 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). | Other | Intervention |
| Standard CareParticipants 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). | Other | Control |
Primary outcome
Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program
Time frame: an average of 4 years
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
6 secondary outcomes
Clinical-functional assessment
Time frame: an average of 4 years
Saint George's Respiratory Questionnaire (SGRQ)
Time frame: an average of 4 years
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: an average of 4 years
Pulmonary function measurements
Time frame: an average of 4 years
Handgrip strength (HGS)
Time frame: an average of 4 years
Quadriceps strength (QS)
Time frame: an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 23743314Aggarwal 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.
- Background: PubMed 32912387Allwood 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.
- Background: PubMed 32494129Allwood BW, Maasdorp E, Kim GJ, Cooper CB, Goldin J, van Zyl-Smit RN, Bateman ED, Dawson R. Transition from Restrictive to Obstructive Lung Function Impairment During Treatment and Follow-Up of Active Tuberculosis. Int J Chron Obstruct Pulmon Dis. 2020 May 11;15:1039-1047. doi: 10.2147/COPD.S219731. eCollection 2020.
- Background: PubMed 26113680Amaral AF, Coton S, Kato B, Tan WC, Studnicka M, Janson C, Gislason T, Mannino D, Bateman ED, Buist S, Burney PG; BOLD Collaborative Research Group. Tuberculosis associates with both airflow obstruction and low lung function: BOLD results. Eur Respir J. 2015 Oct;46(4):1104-12. doi: 10.1183/13993003.02325-2014. Epub 2015 Jun 25.
- Background: PubMed 20349754Banu Rekha VV, Ramachandran R, Kuppu Rao KV, Rahman F, Adhilakshmi AR, Kalaiselvi D, Murugesan P, Sundaram V, Narayanan PR. Assessment of long term status of sputum positive pulmonary TB patients successfully treated with short course chemotherapy. Indian J Tuberc. 2009 Jul;56(3):132-40.
- BackgroundBogossian M, Santoro IL, Jamnik S, Romaldini H. Bronchiectasis: a study of 314 cases tuberculosis x nontuberculosis. J Bra Pneumol. 1998; 24(1): 11-6.
- BackgroundBrasil. Ministério da Saúde. Manual de Recomendações para o Controle da Tuberculose no Brasil 2019. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/manual_recomendacoes_controle_tuberculose_brasil_2_ed.pdf
- Background: PubMed 30508589Butzko RP, Sotolongo AM, Helmer DA, Klein-Adams JC, Osinubi OY, Berman AR, Ortiz-Pacheco R, Falvo MJ. Forced oscillation technique in veterans with preserved spirometry and chronic respiratory symptoms. Respir Physiol Neurobiol. 2019 Feb;260:8-16. doi: 10.1016/j.resp.2018.11.012. Epub 2018 Nov 30.
- Background: PubMed 25809770Byrne AL, Marais BJ, Mitnick CD, Lecca L, Marks GB. Tuberculosis and chronic respiratory disease: a systematic review. Int J Infect Dis. 2015 Mar;32:138-46. doi: 10.1016/j.ijid.2014.12.016.
- Background: PubMed 30808453Chin AT, Rylance J, Makumbirofa S, Meffert S, Vu T, Clayton J, Mason P, Woodruff P, Metcalfe J. Chronic lung disease in adult recurrent tuberculosis survivors in Zimbabwe: a cohort study. Int J Tuberc Lung Dis. 2019 Feb 1;23(2):203-211. doi: 10.5588/ijtld.18.0313.
- Background: PubMed 31392293Daniels KJ, Irusen E, Pharaoh H, Hanekom S. Post-tuberculosis health-related quality of life, lung function and exercise capacity in a cured pulmonary tuberculosis population in the Breede Valley District, South Africa. S Afr J Physiother. 2019 Jul 31;75(1):1319. doi: 10.4102/sajp.v75i1.1319. eCollection 2019.
- BackgroundDe Sousa TC, Jardim JR, Jones P. Validation of the Saint George's Respiratory Questionnaire in patients with chronic obstructive pulmonary disease in Brazil. J Pneumologia 2000; 26(3): 119-128.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pulmonary Tuberculosis, run by Centro Universitário Augusto Motta at 2 sites 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnaldo José Lopes, DsC (+55 21998536162, agnaldolopes.uerj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program (time frame: an average of 4 years). 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 NCT06127641, which also lists 68 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 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.