COPDNCT04604717
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
A study testing Pulmonary rehabilitation in people with COPD, run by Bayside Health at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesAustralia
- Study dates
- Apr 2014to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD (FEV1/FVC < 70), smoking Hx of minimum of 10 pack years
Who cannot join
- Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alfred Health
Melbourne, Victoria, 3004
Austin Health
Melbourne, Victoria, 3084
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Pulmonary rehabilitation
- Keywords
- COPD,, Pulmonary rehabilitation,, Airway immunity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
8 weeks of exercise training (twice weekly) of education and exercise
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | 8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program Receives: Other: Pulmonary rehabilitation |
| Control group | No intervention | Usual medical treatment for 8 week period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Immunoglobulin A levels
SIgA
Measured: Change over 8 weeks
Secondary outcomes (5)
Change in circulatory inflammatory markers
Measured: Change over 8 weeks
Change in physical activity levels
Measured: Change over 8 weeks
Health status
COPD assessment test
Measured: Change over 8 weeks
Exercise capacity (6MWT)
Distance walked in 6 minutes
Measured: Change over 8 weeks
Number of acute exacerbations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study startApr 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Austin Health, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Anne Holland, PhD, Principal investigator, Alfred Health, La Trobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604717
- Sponsor's protocol ID
- 110314
- Other IDs
- IBAS110314
- Status last verified
- Oct 2020
- First submitted
- 11 Mar 2014
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04604717
- Acronym / sponsor ID
- 110314
- Conditions
- COPD
- Keywords
- COPD,, Pulmonary rehabilitation,, Airway immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Austin Health, Newcastle University
- Study start
- Apr 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitation8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program |
| Control group | No intervention | –Usual medical treatment for 8 week period |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD (FEV1/FVC < 70), smoking Hx of minimum of 10 pack years
Key exclusion criteria (1 listed)
- Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation8 weeks of exercise training (twice weekly) of education and exercise | Other | Pulmonary rehabilitation |
Primary outcome
Change in Salivary Immunoglobulin A levels
Time frame: Change over 8 weeks
SIgA
5 secondary outcomes
Change in circulatory inflammatory markers
Time frame: Change over 8 weeks
Change in physical activity levels
Time frame: Change over 8 weeks
Health status
Time frame: Change over 8 weeks
Exercise capacity (6MWT)
Time frame: Change over 8 weeks
Number of acute exacerbations
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Holland, PhD principal investigator
Alfred Health, La Trobe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with COPD, run by Bayside Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Immunoglobulin A levels (time frame: Change over 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.