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NCT Number: NCT07709507

Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age 18 years or older.
  • Documented history of pulmonary tuberculosis with anti-tuberculosis treatment completed according to national standards.
  • No clinical evidence of active or relapsed tuberculosis at enrollment; microbiological reassessment will be performed when clinically indicated.
  • Persistent respiratory symptoms, exercise limitation, or functional impairment considered attributable to post-tuberculosis lung disease.
  • Clinical stability for at least 4 weeks before randomization, with no acute respiratory infection or acute exacerbation requiring treatment change.
  • Ability to walk independently, with or without a usual assistive device, and to perform the study assessments.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

  • • Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation.
  • Acute respiratory infection or acute cardiopulmonary decompensation within 4 weeks before enrollment.
  • Unstable angina, recent myocardial infarction, uncontrolled arrhythmia, decompensated heart failure, severe uncontrolled hypertension, or another contraindication to exercise testing/training.
  • Severe neurological, musculoskeletal, or cognitive impairment that prevents safe participation or valid outcome assessment.
  • Current participation in another structured pulmonary rehabilitation or supervised exercise program.
  • Planned major surgery or another condition likely to prevent completion of the 20-week follow-up.
  • Any condition judged by the investigator to make participation unsafe or to substantially interfere with interpretation of the outcomes.

Treatment and study plan

Individualized Pulmonary Rehabilitation Program

Behavioral

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

Other

Standard Post-Tuberculosis Care

Primary outcomes

  1. Change From Baseline in EUROHIS-QOL-8 Total Score

    Time frame: Baseline, Week 8, and Week 20.

    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.

  2. Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20

    Time frame: Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.

    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.

Other outcomes

  1. Change From Baseline in Six-Minute Walk Distance

    Time frame: Baseline, Week 8, and Week 20

    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.

  2. Change From Baseline in Timed Up and Go Test Performance

    Time frame: Baseline, Week 8, and Week 20.

    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.

  3. Change From Baseline in Modified Medical Research Council Dyspnea Grade

    Time frame: Baseline, Week 8, and Week 20.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

MAGDALENA-RODICA TRAISTARU, Professor, PhD

CONTACT

[email protected]

+40723766778

Sponsors and collaborators

Lead sponsor

Filantropia Hospital

Other

Registry information

Official study title

Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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