Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease
Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: MAGDALENA-RODICA TRAISTARU, Professor, PhD
- Puhelinnumero: +40723766778
- Sähköposti: rodica.traistaru@umfcv.ro
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Individualized Pulmonary Rehabilitation Plus Standard Care
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.
|
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
|
|
Active Comparator: 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.
|
Standard Post-Tuberculosis Care
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in EUROHIS-QOL-8 Total Score
Aikaikkuna: 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.
|
Baseline, Week 8, and Week 20.
|
|
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
Aikaikkuna: 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.
|
Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Six-Minute Walk Distance
Aikaikkuna: 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.
|
Baseline, Week 8, and Week 20
|
|
Change From Baseline in Timed Up and Go Test Performance
Aikaikkuna: 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.
|
Baseline, Week 8, and Week 20.
|
|
Change From Baseline in Modified Medical Research Council Dyspnea Grade
Aikaikkuna: 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.
|
Baseline, Week 8, and Week 20.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Infektiot
- Hengityselinten sairaudet
- Hengityshäiriöt
- Merkit ja oireet, Hengityselimet
- Gram-positiiviset bakteeri-infektiot
- Bakteeri-infektiot
- Bakteeri-infektiot ja mykoosit
- Actinomycetales -infektiot
- Mycobacterium-infektiot
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Tuberkuloosi
- Hengenahdistus
Muut tutkimustunnusnumerot
- UMFCV-PTLD-2026-001
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .