Assessment of health-related quality of life in patients with pulmonary tuberculosis under programme conditions.
A N Aggarwal, D Gupta, A K Janmeja...
https://pubmed.ncbi.nlm.nih.gov/23743314Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06127641
Rehabilitation of People With Post-tuberculosis Lung Disease
Led by Centro Universitário Augusto Motta · Updated on 2023-11-13
40
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Centro Universitário Augusto Motta
Lead Sponsor
R
Rio de Janeiro State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tuberculosis (TB) survivors often face ongoing lung problems known as post-TB lung disease (PD-PTB), which can cause disabling symptoms and impact long-term health. This research aims to evaluate how pulmonary rehabilitation (PR) affects the daily functioning and quality of life of people living with PD-PTB. Additionally, the study plans to develop a severity scoring system for PD-PTB using artificial intelligence based on data from individuals before starting rehabilitation. The study is a randomized controlled trial involving two groups: one receiving standard care alone, and the other receiving standard care plus a 12-week pulmonary rehabilitation program. The rehabilitation sessions occur three times a week and include aerobic training on a cycle ergometer, breathing exercises, muscle conditioning, airway clearance, psychological support, relaxation, and nutritional counseling. Participants also attend educational group sessions led by a respiratory physiotherapist on lifestyle and physical activity. Participants will be assessed before and after the rehabilitation program using tests like the Glittre-ADL to measure functional capacity with dynamic ventilation, lung function tests including impulse oscillometry, respiratory and muscle strength evaluations, fatigue questionnaires, and health-related quality of life surveys. The study monitors clinical and functional outcomes over about four years, aiming to help patients improve their ability to engage in daily activities and potentially return to work or society. Safety and adherence to the rehabilitation are also observed throughout the study.
CONDITIONS
Brief Title
Rehabilitation of People With Post-tuberculosis Lung Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with post-tuberculosis lung disease who are clinically stable
- Able to participate in more than 80% of the training sessions
You will not qualify if you...
- Presence of medical conditions not related to post-tuberculosis lung disease
- Unable to perform the Glittre-ADL test
- Cognitive changes that impair participation
- Treatment abandonment during pulmonary rehabilitation protocol
- Uncontrolled hypertension or use of psychotropic medications
- Significant limitations due to osteoarthropathy
- Having had any orthopedic surgery in the previous year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants undergo pulmonary rehabilitation or standard care to improve lung function and quality of life after tuberculosis.
Up to 36 outpatient visits (3 times per week)
Follow-up
Duration - Approximately 4 years
Participants are monitored to assess long-term functional capacity, respiratory health, and quality of life after treatment.
Periodic assessments over 4 years
Trial Site Locations
Total: 2 locations
1
Agnaldo José Lopes
Rio de Janeiro, Brazil, 22745-271
Actively Recruiting
2
Centro Universitario Augusto Motta
Rio de Janeiro, Brazil, 22745271
Actively Recruiting
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Research Team
A
Agnaldo José Lopes, DsC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Post-tuberculosis lung health: perspectives from the First International Symposium.
B W Allwood, M M van der Zalm, A F S Amaral...
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Brian W Allwood, Elizna Maasdorp, Grace J Kim...
https://pubmed.ncbi.nlm.nih.gov/32494129Tuberculosis associates with both airflow obstruction and low lung function: BOLD results.
André F S Amaral, Sonia Coton, Bernet Kato...
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Ryan P Butzko, Anays M Sotolongo, Drew A Helmer...
https://pubmed.ncbi.nlm.nih.gov/30508589Tuberculosis and chronic respiratory disease: a systematic review.
Anthony L Byrne, Ben J Marais, Carole D Mitnick...
https://pubmed.ncbi.nlm.nih.gov/25809770Chronic lung disease in adult recurrent tuberculosis survivors in Zimbabwe: a cohort study.
A T Chin, J Rylance, S Makumbirofa...
https://pubmed.ncbi.nlm.nih.gov/30808453Post-tuberculosis health-related quality of life, lung function and exercise capacity in a cured pulmonary tuberculosis population in the Breede Valley District, South Africa.
Kurt J Daniels, Elvis Irusen, Hamilton Pharaoh...
https://pubmed.ncbi.nlm.nih.gov/31392293Profile of patients with post-tuberculosis bronchiectasis in a tertiary care hospital in Brazil.
Vitor Loureiro Dias, Mariane Gonçalves Martynychen Canan, Cleverson Alex Leitão...
https://pubmed.ncbi.nlm.nih.gov/36405996