Rehabilitation of People With Post-tuberculosis Lung Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of People With Post-tuberculosis Lung Disease

Conditions
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Pulmonary Tuberculosis

Intervention / Treatment
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* Other: Standard care plus pulmonary rehabilitation
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Participants will receive standard care (SC) | Other: Standard Care<br>* 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).<br>|
| Experimental: Intervention<br>Participants will receive the standard care (SC) plus pulmonary rehabilitation (PR) | Other: Standard care plus pulmonary rehabilitation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical-functional assessment | Clinical examination and anthropometric measurements | 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. | 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). | 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. | 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) | 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). | an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary tuberculosis, Tuberculosis sequelae, Rehabilitation, ADL-Glittre test, Functionality, Quality of life