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Clinical Trials in Brazil / NCT06127641
Recruiting Not applicable

Rehabilitation of People With Post-tuberculosis Lung Disease

NCT06127641 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2023-10-28
Last updated
2023-11-13

Condition(s) studied

Pulmonary Tuberculosis

Investigational drug(s) / intervention(s)

Standard care plus pulmonary rehabilitationStandard Care

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, 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 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 breathing and segmental breathing) and secretion removal training (coughing exercise, huffing , assisted cough and postural drainage).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Agnaldo José Lopes Rio de Janeiro Brazil Recruiting
Centro Universitario Augusto Motta Rio de Janeiro Brazil Recruiting

More Centro Universitário Augusto Motta trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06127641 on ClinicalTrials.gov ↗ ← All trials in Brazil