Clinical trial NCT06127641: Rehabilitation of People With Post-tuberculosis Lung Disease
Official title: Rehabilitation of People With Post-tuberculosis Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Tuberculosis
Keywords: Pulmonary tuberculosis
Tuberculosis sequelae
Rehabilitation
ADL-Glittre test
Functionality
Quality of life
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2023-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program
timeFrame: an average of 4 years
Secondary outcomes:
measure: Clinical-functional assessment
timeFrame: an average of 4 years
measure: Saint George's Respiratory Questionnaire (SGRQ)
timeFrame: an average of 4 years
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: an average of 4 years
measure: Pulmonary function measurements
timeFrame: an average of 4 years
measure: Handgrip strength (HGS)
timeFrame: an average of 4 years
measure: Quadriceps strength (QS)
timeFrame: an average of 4 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Agnaldo José Lopes
city: Rio De Janeiro
country: Brazil
facility: Centro Universitario Augusto Motta
Study officials:
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