Rehabilitation of People With Post-tuberculosis Lung Disease
NCT ID: NCT06127641
Last Updated: 2023-11-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-28
Study Completion Date
2027-12-31
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.
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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.
Conditions
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Pulmonary Tuberculosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized Clinical Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Control
Participants will receive standard care (SC)
Group Type
ACTIVE_COMPARATOR
Standard Care
Intervention Type
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).
Intervention
Participants will receive the standard care (SC) plus pulmonary rehabilitation (PR)
Group Type
EXPERIMENTAL
Standard care plus pulmonary rehabilitation
Intervention Type
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).
Interventions
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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).
Intervention Type
OTHER
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).
Intervention Type
OTHER
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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Rio de Janeiro State University
OTHER
Sponsor Role
collaborator
Centro Universitário Augusto Motta
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Agnaldo José Lopes
Rio de Janeiro, , Brazil
Site Status
RECRUITING
Centro Universitario Augusto Motta
Rio de Janeiro, , Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
70493823.5.0000.5259
Identifier Type: -
Identifier Source: org_study_id
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