Effect of Exercise Training on Salivary Immunoglobulin A... | NCT04604717

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

NCT04604717

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Oct 27, 2020Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Pulmonary rehabilitation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IBAS110314	Other Grant/Funding Number	IBAS13

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Oct 21, 2020

First Posted Date

Oct 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2020

Last Update Posted Date

Oct 27, 2020Actual

Name	Class
Austin Health	OTHER_GOV
Newcastle University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary rehabilitation	Experimental	8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program	Other: Pulmonary rehabilitation
Control group	No Intervention	Usual medical treatment for 8 week period

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation	Other	8 weeks of exercise training (twice weekly) of education and exercise	Pulmonary rehabilitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in circulatory inflammatory markers		Change over 8 weeks
Change in physical activity levels		Change over 8 weeks
Health status

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Holland, PhD	Alfred Health, La Trobe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Health		Melbourne	Victoria	3004	Australia
Austin Health

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided