Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease

October 21, 2020 updated by: Bayside Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary rehabilitation
8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program
Other: Pulmonary rehabilitation
8 weeks of exercise training (twice weekly) of education and exercise
No Intervention: Control group
Usual medical treatment for 8 week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Salivary Immunoglobulin A levels
Time Frame: Change over 8 weeks
SIgA
Change over 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in circulatory inflammatory markers
Time Frame: Change over 8 weeks
Change over 8 weeks
Change in physical activity levels
Time Frame: Change over 8 weeks
Change over 8 weeks
Health status
Time Frame: Change over 8 weeks
COPD assessment test
Change over 8 weeks
Exercise capacity (6MWT)
Time Frame: Change over 8 weeks
Distance walked in 6 minutes
Change over 8 weeks
Number of acute exacerbations
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

Newcastle University
Austin Health

Investigators

  • Principal Investigator: Anne Holland, PhD, Alfred Health, La Trobe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110314
  • IBAS110314 (Other Grant/Funding Number: IBAS13)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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