Rehabilitation of People With Post-tuberculosis Lung Disease
ConditionPulmonary Tuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Universitário Augusto Motta
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with post-tuberculosis lung disease, clinically stable and able to perform >80% of training sessions.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard care plus pulmonary rehabilitation
Other interventionA 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
Other interventionParticipants 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
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
Time frame
an average of 4 yearsSecondary outcomes
1
Clinical-functional assessment
Clinical examination and anthropometric measurements
Time frame
an average of 4 years2
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.
Time frame
an average of 4 years3
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).
Time frame
an average of 4 years4
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.
Time frame
an average of 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centro Universitário Augusto Motta
Lead sponsor
Rio de Janeiro State University
Collaborator
Source ClinicalTrials.gov