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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04604717
Other study ID # 110314
Secondary ID IBAS110314
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date June 30, 2017

Study information

Verified date October 2020
Source Bayside Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether whole body exercise training alters the immunity in the lungs of people with COPD and reduces the incidence of chest infections over the longer term.


Description:

Patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and education. Those who decline to take part in pulmonary rehabilitation will have the same outcome measures collected at the same timepoints.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - Diagnosis of COPD (FEV1/FVC < 70), smoking Hx of minimum of 10 pack years Exclusion Criteria: - Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation
8 weeks of exercise training (twice weekly) of education and exercise

Locations

Country Name City State
Australia Alfred Health Melbourne Victoria
Australia Austin Health Melbourne Victoria

Sponsors (3)

Lead Sponsor Collaborator
Bayside Health Austin Health, Newcastle University

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Salivary Immunoglobulin A levels SIgA Change over 8 weeks
Secondary Change in circulatory inflammatory markers Change over 8 weeks
Secondary Change in physical activity levels Change over 8 weeks
Secondary Health status COPD assessment test Change over 8 weeks
Secondary Exercise capacity (6MWT) Distance walked in 6 minutes Change over 8 weeks
Secondary Number of acute exacerbations 12 months
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