- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02179983
Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial (TRIBE)
A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of COPD, rehabilitation is associated with reduced frequency of exacerbations and improved exercise capacity. No data are available in bronchiectasis.
This study will randomly assign patients with bronchiectasis exacerbations to pulmonary rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by pulmonary rehabilitation at 8 weeks.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Pulmonary rehabilitation is an effective treatment after exacerbations of COPD to prevent future exacerbations and to improve breathlessness and quality of life. Its effectiveness after exacerbations of bronchiectasis has never been demonstrated.
Aims: To determine if a 6 week course of pulmonary rehabilitation improves exercise capacity at 8 weeks after exacerbation.
Study Design: Randomised controlled trial. Methods: The study will take place in NHS Tayside. 40 patients with a history of bronchiectasis confirmed by HRCT will be included. Patients will be monitored using diary cards for exacerbations. At the onset of an exacerbation patients will be treated with a standard 14 day course of antibiotic therapy and randomised to one of two arms: Pulmonary rehabilitation or standard care. Patients randomised to pulmonary rehabilitation will undergo a 6 week course of supervised pulmonary rehabilitation. Patients will undergo study assessments (6-minute walk test, Quality of life questionnaires, pulmonary function tests (FEV1, FVC, FEF 25-75), symptoms recorded by symptom diaries and sputum microbiology).Assessments will be performed at the start and end of exacerbations, at 6-8 weeks post exacerbation (after completion of pulmonary rehabilitation in patients randomised to rehabilitation) and at 12 weeks.
Outcome: The primary outcome is 6 minute walk distance at 8 week post exacerbation Expected Conclusion: We will determine the effectiveness of pulmonary rehabilitation after exacerbations of bronchiectasis.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Dundee, Det Forenede Kongerige, DD1 9SY
- Clinical Research Centre, University of Dundee
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Bronchiectasis confirmed on High Resolution CT scan Clinical Bronchiectasis confirmed by a respiratory physician. Documented exacerbation within the last year. Independently mobile - i.e. able to undertake pulmonary rehabilitation
Exclusion Criteria:
- Inability to give informed consent to participate
- Age <18 years
- Primary diagnosis of Chronic Obstructive Pulmonary Disease
- Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease.
- Cystic Fibrosis
- Aortic aneurysm
- Recent myocardial infarction (within previous year)or unstable angina
Studieplan
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 |
---|---|
Ingen indgriben: Standard care
Standard care for exacerbation and follow-up without rehabilitation
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Eksperimentel: Pulmonary rehabilitation
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
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6 weeks of supervised exercise and education (pulmonary rehabilitation)
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
6 minute walk distance
Tidsramme: 8 weeks post exacerbation
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8 weeks post exacerbation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Tid til næste eksacerbation
Tidsramme: 6 måneder
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6 måneder
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The Quality of life
Tidsramme: 8 weeks and 12 weeks
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St Georges respiratory questionnaire COPD assessment test
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8 weeks and 12 weeks
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Pulmonary function tests
Tidsramme: 8 weeks and 12 weeks
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Pulmonary function tests (FEV1, FVC, FEF25-75)
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8 weeks and 12 weeks
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Respiratory symptoms
Tidsramme: 8 weeks and 12 weeks
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Patient diary cards
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8 weeks and 12 weeks
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Sputum microbiology
Tidsramme: 8 weeks and 12 weeks
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Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation.
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8 weeks and 12 weeks
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6 minute walk distance
Tidsramme: 12 weeks
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12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: James D Chalmers, MBChB, PhD, NHS Tayside
- Ledende efterforsker: Tom Fardon, MD, NHS Tayside
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NHSTayside
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