Trial Review

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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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04604717