Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease

12. juli 2026 opdateret af: Diana Kamal, Filantropia Hospital

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Individualized Pulmonary 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

Andet: Standard Post-Tuberculosis Care
Standard Post-Tuberculosis Care
Aktiv komparator: 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.
Andet: Standard Post-Tuberculosis Care
Standard Post-Tuberculosis Care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in EUROHIS-QOL-8 Total Score
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Six-Minute Walk Distance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Filantropia Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

15. november 2026

Studieafslutning (Anslået)

10. december 2026

Datoer for studieregistrering

Først indsendt

12. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UMFCV-PTLD-2026-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tuberkulose (TB)

Kliniske forsøg med Individualized Pulmonary Rehabilitation Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner