Post TuberculosisNCT07451899
TB Type and Spirometry Result vs. Functional Capacity Based on 6MWT in People With Post-TB Lung Disease
An observational study of Post Tuberculosis and Lung Disease, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Post Tuberculosis, Lung Disease, Functional Capacity
- How many people
- 23 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Post tuberculosis patient who come to Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung
Who may be able to join
- Adolescents (10-18 year old)
- Diagnosed with post tuberculosis lung disease by pediatrician
- Capable of performing the 6MWT
Who cannot join
- Diagnosed with another lung disease
- Having physical limitations that hinder the 6MWT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irma R Defi, MD, PhD, Principal investigator, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451899
- Sponsor's protocol ID
- IKFR-202602.01
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07451899
- Acronym / sponsor ID
- IKFR-202602.01
- Conditions
- Post Tuberculosis, Lung Disease, Functional Capacity, Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Post tuberculosis patient who come to Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung
Key inclusion criteria (3 listed)
- Adolescents (10-18 year old)
- Diagnosed with post tuberculosis lung disease by pediatrician
- Capable of performing the 6MWT
Key exclusion criteria (2 listed)
- Diagnosed with another lung disease
- Having physical limitations that hinder the 6MWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 6-Minute Walk Distance (6MWD) measured in METs
Time frame: 12 weeks
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.
Forced Expiratory Volume in 1 second (FEV1) in liter
Time frame: 12 weeks
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.
Forced Vital Capacity (FVC) in liters
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma R Defi, MD, PhD principal investigator
Hasan Sadikin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Tuberculosis and Lung Disease, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-Minute Walk Distance (6MWD) measured in METs (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.