An interventional study of Individualized Pulmonary Rehabilitation Program and Standard Post-Tuberculosis Care in Post-tuberculosis Lung Disease and Tuberculosis (TB), sponsored by Filantropia Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Filantropia Hospital · Not applicable, Interventional, and Treatment
Post-tuberculosis lung disease (PTLD) refers to persistent respiratory symptoms, functional limitation, and/or structural or physiological abnormalities after completion of anti-tuberculosis treatment. These consequences can reduce exercise capacity and quality of life. This randomized controlled study will evaluate whether an individualized pulmonary rehabilitation program provides greater and more sustained improvement than standard care in adults with PTLD. Participants will be allocated in a 1:1 ratio to an 8-week supervised pulmonary rehabilitation program plus standard care or to standard care alone. Assessments will be performed at baseline (T0), immediately after the 8-week program (T1), and 3 months after program completion (T2; Week 20). The primary outcome will be the change in St George's Respiratory Questionnaire total score from baseline to Week 20. Secondary outcomes will include exercise capacity, mobility, dyspnea, perceived exertion, additional quality-of-life measures, blood-cell-derived inflammatory indices, adherence, and adverse events.
Persistent impairment after successfully treated pulmonary tuberculosis is increasingly recognized as an important source of chronic respiratory morbidity. Patients may experience dyspnea, exercise intolerance, fatigue, impaired mobility, and reduced health-related quality of life. Preliminary retrospective data from 37 patients suggested that structured pulmonary rehabilitation may improve the 6-minute walk distance, Timed Up and Go performance, dyspnea, perceived exertion, quality of life, and selected inflammatory indices. However, retrospective allocation and the absence of a longer follow-up limit causal interpretation.
The present study is designed as a prospective, assessor-blinded, parallel-group randomized controlled trial. It will assess both the immediate response to an individualized rehabilitation program and the maintenance of benefit three months after the supervised program has ended. The intervention combines aerobic training, resistance training, breathing exercises, education, and individualized symptom-management strategies. The control group will receive usual post-tuberculosis medical care and general physical-activity advice without a structured supervised pulmonary rehabilitation program during the study period.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Filantropia Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Age 18 years or older.
Exclusion Criteria:
Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the experimental arm will receive an 8-week individualized pulmonary rehabilitation program in addition to standard post-tuberculosis medical care. The program will include three supervised sessions per week, each lasting approximately 60 minutes, consisting of aerobic training, resistance exercises, breathing exercises, education, symptom-management strategies, and an individualized home exercise program. Outcome assessments will be performed at baseline, immediately after the 8-week intervention, and three months after completion of the rehabilitation program.
Behavioral: Individualized Pulmonary Rehabilitation Program · Other: Standard Post-Tuberculosis Care
Participants assigned to the control arm will receive standard post-tuberculosis medical care, including routine clinical follow-up, management of respiratory symptoms and comorbidities, and general recommendations regarding physical activity. Participants in this arm will not receive a structured or supervised pulmonary rehabilitation program during the 20-week study period. Outcome assessments will be performed at baseline, at Week 8, and at Week 20.
Other: Standard Post-Tuberculosis Care
The intervention consists of an 8-week individualized outpatient pulmonary rehabilitation program, delivered through three supervised sessions per week, with each session lasting approximately 60 minutes. Each session will include: 5-10 minutes of warm-up and mobility exercises; 20-30 minutes of individualized aerobic training, such as walking, treadmill exercise, or cycle ergometry; resistance exercises targeting the major upper- and lower-limb muscle groups; breathing exercises, including diaphragmatic breathing, pursed-lip breathing, and thoracic expansion exercises; airway-clearance techniques when clinically indicated; education regarding symptom monitoring, energy conservation, physical activity, treatment adherence, and healthy lifestyle; an individualized home exercise program on non-supervised days. Exercise intensity and progression will be individualized according to baseline functional capacity, symptoms, Borg CR10 score, heart rate, oxygen saturation, comorbidities, and
Standard Post-Tuberculosis Care
Change From Baseline in EUROHIS-QOL-8 Total Score
Generic quality of life will be assessed using the EUROHIS-QOL-8 questionnaire. The questionnaire contains eight items scored from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating better quality of life. A positive change indicates improvement.
Time frame: Baseline, Week 8, and Week 20.
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
Respiratory health-related quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ). The total score ranges from 0 to 100, with higher scores indicating greater impairment. The outcome will be calculated as the Week 20 score minus the baseline score. A negative change indicates an improvement in respiratory health-related quality of life.
Time frame: Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
Change From Baseline in Six-Minute Walk Distance
Functional exercise capacity will be assessed using the 6-Minute Walk Test. The total distance walked in six minutes will be recorded in meters. A greater walking distance indicates better functional exercise capacity.
Time frame: Baseline, Week 8, and Week 20
Change From Baseline in Timed Up and Go Test Performance
Functional mobility will be assessed using the Timed Up and Go test. The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds. A shorter completion time indicates better functional mobility.
Time frame: Baseline, Week 8, and Week 20.
Change From Baseline in Modified Medical Research Council Dyspnea Grade
Dyspnea during daily activities will be assessed using the modified Medical Research Council scale. Scores range from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. A reduction in score indicates improvement.
Time frame: Baseline, Week 8, and Week 20.
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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