Back to resultsEffect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD,, Pulmonary rehabilitation,, Airway immunity
Eligibility Criteria
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
Sites / Locations
- Alfred Health
- Austin Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pulmonary rehabilitation
Control group
Arm Description
8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program
Usual medical treatment for 8 week period
Outcomes
Primary Outcome Measures
Change in Salivary Immunoglobulin A levels
SIgA
Secondary Outcome Measures
Change in circulatory inflammatory markers
Change in physical activity levels
Health status
COPD assessment test
Exercise capacity (6MWT)
Distance walked in 6 minutes
Number of acute exacerbations
Full Information
NCT ID
NCT04604717
First Posted
March 11, 2014
Last Updated
October 21, 2020
Sponsor
Bayside Health
Collaborators
Austin Health, Newcastle University
1. Study Identification
Unique Protocol Identification Number
NCT04604717
Brief Title
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Austin Health, Newcastle University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD,, Pulmonary rehabilitation,, Airway immunity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual medical treatment for 8 week period
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
8 weeks of exercise training (twice weekly) of education and exercise
Primary Outcome Measure Information:
Title
Change in Salivary Immunoglobulin A levels
Description
SIgA
Time Frame
Change over 8 weeks
Secondary Outcome Measure Information:
Title
Change in circulatory inflammatory markers
Time Frame
Change over 8 weeks
Title
Change in physical activity levels
Time Frame
Change over 8 weeks
Title
Health status
Description
COPD assessment test
Time Frame
Change over 8 weeks
Title
Exercise capacity (6MWT)
Description
Distance walked in 6 minutes
Time Frame
Change over 8 weeks
Title
Number of acute exacerbations
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Holland, PhD
Organizational Affiliation
Alfred Health, La Trobe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
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