Rehabilitation of People With Post-tuberculosis Lung Disease

NCT06127641 | Recruiting

• 1 other identifier: 70493823.5.0000.5259
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Pulmonary Tuberculosis

Keywords

Pulmonary tuberculosis; Tuberculosis sequelae; Rehabilitation; ADL-Glittre test; Functionality; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Clinical-functional assessment

  an average of 4 years

• Saint George's Respiratory Questionnaire (SGRQ)

  an average of 4 years

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  an average of 4 years

• Pulmonary function measurements

  an average of 4 years

• Handgrip strength (HGS)

  an average of 4 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants will receive standard care (SC)

Other: Standard Care

Intervention

EXPERIMENTAL

Participants will receive the standard care (SC) plus pulmonary rehabilitation (PR)

Other: Standard care plus pulmonary rehabilitation

Interventions

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).

Intervention

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).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of comorbidities not related to PD-PTB.
• Patients with inability to perform TGlittre.
• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Rio de Janeiro State University: collaborator

Study Sites (2)

Agnaldo José Lopes

Rio de Janeiro, 22745-271, Brazil

RECRUITING

Centro Universitario Augusto Motta

Rio de Janeiro, 22745271, Brazil

RECRUITING

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• 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.

  PMID: 32082283 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.

  BACKGROUND

• 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.

  PMID: 41035122 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Agnaldo José Lopes, DsC

CONTACT

+55 21998536162; agnaldolopes.uerj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 13, 2023
• Study Start: October 28, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

BR (2)