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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04604717




Registration number
NCT04604717
Ethics application status
Date submitted
11/03/2014
Date registered
27/10/2020
Date last updated
27/10/2020

Titles & IDs
Public title
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Scientific title
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
IBAS110314
Secondary ID [2] 0 0
110314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pulmonary rehabilitation

Experimental: Pulmonary rehabilitation - 8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program

No intervention: Control group - Usual medical treatment for 8 week period


Other interventions: Pulmonary rehabilitation
8 weeks of exercise training (twice weekly) of education and exercise
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Salivary Immunoglobulin A levels
Timepoint [1] 0 0
Change over 8 weeks
Secondary outcome [1] 0 0
Change in circulatory inflammatory markers
Timepoint [1] 0 0
Change over 8 weeks
Secondary outcome [2] 0 0
Change in physical activity levels
Timepoint [2] 0 0
Change over 8 weeks
Secondary outcome [3] 0 0
Health status
Timepoint [3] 0 0
Change over 8 weeks
Secondary outcome [4] 0 0
Exercise capacity (6MWT)
Timepoint [4] 0 0
Change over 8 weeks
Secondary outcome [5] 0 0
Number of acute exacerbations
Timepoint [5] 0 0
12 months

Eligibility
Key inclusion criteria
* Diagnosis of COPD (FEV1/FVC < 70), smoking Hx of minimum of 10 pack years
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Newcastle University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04604717
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Holland, PhD
Address 0 0
Alfred Health, La Trobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04604717