NCT07451899

TB Type and Spirometry Result vs. Functional Capacity Based on 6MWT in People With Post-TB Lung Disease

Correlation Between Types of Tuberculosis, Spirometry Result, and Functional Capacity Based on the 6-Minute Walk Test (6MWT) in Adolescents With Post-Tuberculosis Lung Disease.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Post-Tuberculosis Lung Disease (PTLD) is defined as chronic respiratory impairment due to previous pulmonary TB. Children recovering from pulmonary TB undergo ongoing respiratory health challenges, including more frequent respiratory symptoms, reduced lung volumes, and a threefold higher rate of pulmonary dysfunction compared to healthy children. These conditions could lead to long-term health consequences such as difficulties in performing daily activities. Pulmonary function impairment in PTLD includes approximately 10% of patients losing more than 50% of lung function. Adolescents who have undergone TB treatment often experience pulmonary function impairment and reduced physical capacity. This aims of this study is to analyze the correlation between type of tuberculosis, spirometry result, and functional capacity in adolescents with post-tuberculosis lung disease. This study is an analytical observational study with a cross-sectional approach. This study is conducted at Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung, starting in March until May 2026. Inclusion criteria including: adolescents (10-18 year old), and diagnosed with post tuberculosis lung disease by pediatrician, and capable of performing the 6MWT. The participants with post TB lung disease will undergo spirometry and functional capacity assessment using the 6-minute walk test (6MWT). Outcomes include spirometry result and functional capacity using 6MWT.

Detailed description

Tuberculosis (TB) remains a major global health problem, ranking second after COVID-19 among infectious agents causing mortality worldwide. Post-Tuberculosis Lung Disease (PTLD) is defined as chronic respiratory impairment following pulmonary TB, with manifestations that affect both large and small airways, reduce life expectancy, increase the risk of TB recurrence, and occur with a prevalence ranging from 18% to 87%. Adolescents recovering from pulmonary TB often experience persistent respiratory symptoms, reduced lung volumes, and impaired exercise capacity, leading to long-term health consequences such as cough, fatigue, shortness of breath, and limitations in daily activities. This study aims to analyze the correlation between type of tuberculosis, spirometry results, and functional capacity in adolescents with PTLD. An analytical observational design with a cross-sectional approach will be employed. The study will be conducted at Hasan Sadikin General Hospital, Bandung, Indonesia, from March to May 2026. Eligible participants are adolescents aged 10-18 years, diagnosed with PTLD by a pediatrician, and capable of performing the 6-Minute Walk Test (6MWT). Exclusion criteria include other lung diseases or physical limitations preventing completion of the 6MWT. Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will complete a forced vital capacity (FVC) maneuver consisting of full inspiration to total lung capacity, followed by a rapid, forceful, and sustained expiration into the mouthpiece for at least 6 seconds (or until a volume plateau is achieved). A subsequent rapid inspiration will be performed to complete the flow-volume loop when required. A minimum of three acceptable maneuvers will be obtained for each participant to ensure reproducibility. Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) will be recorded in liters at each assessment time point. Functional capacity will be assessed using the standardized 6MWT, conducted along a marked corridor. Participants will be instructed to walk back and forth for six minutes, and the total distance covered will be recorded in meters. Metabolic equivalents (METs) will be estimated from walking speed using the ACSM walking equation: VO₂ (ml/kg/min) = 3.5 + 0.1 × speed (m/min), with METs calculated as VO₂/3.5. Both spirometry and 6MWT outcomes will be summarized using descriptive statistics, and correlations between variables will be analyzed using Pearson or Spearman correlation tests, followed by linear regression where appropriate. A significance level of p \< 0.05 will be applied. Ethical approval will be obtained from the institutional ethics committee, and informed consent will be secured from participants and/or guardians. Confidentiality of respondent data will be strictly maintained. The findings are expected to enhance understanding of post-TB recovery, inform specific rehabilitation strategies, and contribute to health interventions for adolescents with PTLD.

Conditions

• Post Tuberculosis
• Lung Disease
• Functional Capacity
• Spirometry

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Indonesia