NCT04604717

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

3.2 years

First QC Date

March 11, 2014

Last Update Submit

October 21, 2020

Conditions

COPD

Keywords

COPD,Pulmonary rehabilitation,Airway immunity

Outcome Measures

Primary Outcomes (1)

  • Change in Salivary Immunoglobulin A levels

    SIgA

    Change over 8 weeks

Secondary Outcomes (5)

  • Change in circulatory inflammatory markers

    Change over 8 weeks

  • Change in physical activity levels

    Change over 8 weeks

  • Health status

    Change over 8 weeks

  • Exercise capacity (6MWT)

    Change over 8 weeks

  • Number of acute exacerbations

    12 months

Study Arms (2)

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

Pulmonary rehabilitationOTHER

8 weeks of exercise training (twice weekly) of education and exercise

Pulmonary rehabilitation

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD (FEV1/FVC \< 70), smoking Hx of minimum of 10 pack years

You may not qualify if:

  • Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Holland, PhD

    Alfred Health, La Trobe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

October 27, 2020

Study Start

April 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

AU(2)