Reducing Dynamic Hyperinflation Through Breathing Retraining
1 other identifier
interventional
119
1 country
1
Brief Summary
This study will compare the effects of exercise training and breathing retraining (using metronome tones) to exercise training only. Exercise training lasts 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
February 1, 2015
4.5 years
November 5, 2009
February 2, 2015
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)
The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.
baseline and 12 weeks
Study Arms (2)
Arm 1
EXPERIMENTALexercise training with breathing retraining
Arm 2
ACTIVE COMPARATORexercise training
Interventions
Eligibility Criteria
You may qualify if:
- yr of age
- FEV1 70%
- FEV1/FVC \< 70%
- RV/TLC 120%
- mean SpO2 90% at peak exercise (w/ or w/o O2)
- Able to hear metronome sounds Lives near Hines, IL (Chicagoland area)
You may not qualify if:
- Respiratory infection/exacerbation within the previous four weeks
- Exercise limiting heart disease (+ stress test or other indicators of heart disease or complaints of angina during the stress test)
- Primary asthma
- Congestive heart failure (New York Heart Association Class III or IV)
- Exercise-limiting peripheral arterial disease (stops exercise due to intermittent claudication)
- Stops exercise due to arthritic pain in the knee or hips (self-report)
- Inability to walk on the treadmill
- Pregnancy
- Any unforeseen illness or disability that would preclude exercise testing or training
- Participation in a formal exercise program within the previous 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
Related Publications (1)
Collins EG, Jelinek C, O'Connell S, Butler J, Reda D, Laghi F. The Effect of Breathing Retraining Using Metronome-Based Acoustic Feedback on Exercise Endurance in COPD: A Randomized Trial. Lung. 2019 Apr;197(2):181-188. doi: 10.1007/s00408-019-00198-4. Epub 2019 Feb 9.
PMID: 30739217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eileen Collins
- Organization
- Edward Hines Jr., VA Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen G. Collins, PhD RN
Edward Hines Jr. VA Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
July 1, 2009
Primary Completion
January 1, 2014
Study Completion
January 1, 2015
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2015-02