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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Disease; Functional Capacity; Spirometry; Post Tuberculosis

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Irma R Defi, MD, PhD; Phone Number: +6216908139; Email: irmaruslina@gmail.com

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Recruiting
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Post tuberculosis patient who come to Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung

Description

Inclusion Criteria:

• Adolescents (10-18 year old)
• Diagnosed with post tuberculosis lung disease by pediatrician
• Capable of performing the 6MWT

Exclusion Criteria:

• Diagnosed with another lung disease
• Having physical limitations that hinder the 6MWT

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-Minute Walk Distance (6MWD) measured in METs	Functional capacity will be assessed using the standardized 6-Minute Walk Test (6MWT), conducted according to American Thoracic Society guidelines. Participants will be instructed to walk back and forth along a marked corridor for six minutes, and the total distance covered will be recorded in meters. In addition, 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 outcomes-distance in meters and estimated METs-will be reported as mean change from baseline at the specified time points.	12 weeks
Forced Expiratory Volume in 1 second (FEV1) in liter	Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform 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. From these maneuvers, Forced Expiratory Volume in 1 second (FEV1) will be recorded in liters at each assessment time point and summarized as mean and standard deviation across participants.	12 weeks
Forced Vital Capacity (FVC) in liters	Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform 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. From these maneuvers, Forced Vital Capacity (FVC) will be recorded in liters at each assessment time point and summarized as mean and standard deviation across participants.	12 weeks

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Irma R Defi, MD, PhD, Hasan Sadikin General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IKFR-202602.01