Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease

NCT07709507 | Not Yet Recruiting

• 1 other identifier: UMFCV-PTLD-2026-001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-tuberculosis Lung Disease; Tuberculosis (TB)

Keywords

pulmonary rehabilitation; dyspnea; quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Other Outcomes (3)

• Change From Baseline in Six-Minute Walk Distance

  Baseline, Week 8, and Week 20

• Change From Baseline in Timed Up and Go Test Performance

  Baseline, Week 8, and Week 20.

• Change From Baseline in Modified Medical Research Council Dyspnea Grade

  Baseline, Week 8, and Week 20.

Study Arms (2)

Individualized Pulmonary Rehabilitation Plus Standard Care

EXPERIMENTAL

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

Standard Post-Tuberculosis Care

ACTIVE COMPARATOR

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

Interventions

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

Individualized Pulmonary Rehabilitation Plus Standard Care

Standard Post-Tuberculosis Care OTHER

Standard Post-Tuberculosis Care

Individualized Pulmonary Rehabilitation Plus Standard Care; Standard Post-Tuberculosis Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Filantropia Hospital: lead

MeSH Terms

Conditions

Tuberculosis; Dyspnea

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MAGDALENA-RODICA TRAISTARU, Professor, PhD

CONTACT

+40723766778; rodica.traistaru@umfcv.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: * Design: prospective, single-center, parallel-group randomized controlled trial. * Allocation ratio: 1:1. * Masking: single-blind outcome assessment; open-label treatment delivery. * Participant duration: approximately 20 weeks. * Assessment points: T0 = baseline; T1 = Week 8, immediately after the supervised program; T2 = Week 20, three months after program completion. * Study setting: Rehabilitation Clinic in Filantropia Hospital, Craiova.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share