Phase 3
N=119
Reducing Dynamic Hyperinflation Through Breathing Retraining
Pulmonary Disease · COPD
Bottom Line
View on ClinicalTrials.gov: NCT01009099 ↗Enrolled (actual)
119
Serious AEs
5.0%
Results posted
Feb 2015
Primary outcome: Primary: Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) — 15.2; 17.6 minutes — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- breathing retraining (Other); exercise training (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) |
15.2; 17.6 | 0.63 |
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.
Eligibility Criteria
Inclusion Criteria
- 40 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01009099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.