Rehabilitation of People With Post-tuberculosis Lung Disease

Overview

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.

Interventions

• Other Standard care plus pulmonary rehabilitation
  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, inspir
• Other Standard Care
  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 bre

Primary outcome measures

• 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]

Secondary outcome measures (6)

• 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]

Eligibility criteria

Inclusion criteria

• Patients with post-tuberculosis lung disease, clinically stable and able to perform >80% of training sessions.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 2 centers

• Agnaldo José Lopes — Rio de Janeiro
• Centro Universitario Augusto Motta — Rio de Janeiro

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. PMID 23743314
• 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 PMID 32912387
• Allwood 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. PMID 32494129
• Amaral 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. PMID 26113680
• Banu 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. PMID 20349754
• Bogossian 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. PMID 30508589

Identifiers

NCT: NCT06127641 · 70493823.5.0000.5259

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗