N/A
N=80
Sustainability of Pulmonary Rehab Gains
COPD
Bottom Line
View on ClinicalTrials.gov: NCT02241733 ↗Enrolled (actual)
80
Serious AEs
38.8%
Results posted
Oct 2019
Primary outcome: Primary: Duration of Exercise Time on a Constant Work-rate Treadmill Test — 12.2; 12.5 change in number of minutes walked — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breathing retraining plus exercise (Behavioral); Exercise only (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Exercise Time on a Constant Work-rate Treadmill Test |
12.2; 12.5 | 0.94 |
| SECONDARY Inspiratory Capacity |
-0.02; .15 | 0.078 |
| SECONDARY 6 Minute Walk Distance |
25.9; 22.8 | 0.80 |
| SECONDARY Mastery Over Breathing |
1.9; 2.3 | 0.76 |
Summary
People with moderate to severe COPD trap air in their lungs. This lessens their ability to exercise. The investigators developed a computerized breathing retraining program to help patients empty their lungs during exercise. The investigators believe that learning to control breathing will help patients be more active. The purpose of this study is to test the effects of using breathing retraining (intervention group) versus no breathing retraining (control group) as part of a 12-week exercise program. The investigators are examining the long term effects of this training on exercise capacity and the ability to empty ones lungs during exercise. Patients will participate in a 12-week exercise program, with or without breathing retraining. They will then participate in a 42 week adherence program to maintain physical activity. Patient testing will be competed at baseline, 12 weeks, 6 months and 1 year. 250 patients with moderate to severe COPD will be enrolled.
Eligibility Criteria
Inclusion Criteria
- >/= 40 yrs
- FEV1 /=120%
- SpO2 >/= 90% at peak exercise (with or without exercise)
- inspiratory capacity decline >.15L from rest to peak exercise
Exclusion Criteria
- respiratory infection/exacerbation within the previous 4 weeks
- exercise limiting heart disease
- primary asthma
- congestive heart failure
- exercise limiting peripheral arterial disease
- stops exercise due to arthritic pain in the knee or hips
- inability to walk on the treadmill
- pregnancy
- methadone use
- 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 (NCT02241733). 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.