Clinical trial NCT01009099: Reducing Dynamic Hyperinflation Through Breathing Retraining
Official title: Reducing Dynamic Hyperinflation Through Breathing Retraining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Disease
COPD
Keywords: pulmonary disease
COPD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-11-06
Enrollment: 119
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Dynamic hyperinflation limits exercise tolerance in chronic obstructive pulmonary disease (COPD). To limit dynamic hyperinflation during exercise and thus improve exercise tolerance, we successfully developed a visual-auditory ventilation-feedback system. The system retrains patient's breathing pattern during exercise. The goal of the current proposal was to develop a user-friendly ventilation-feedback technique with a novel auditory feedback system. We reasoned that the proposed feedback system plus exercise training would be superior to exercise training alone while having the potential for an easier application into clinical practice. Hypotheses: The primary hypothesis is that the exercise duration of patients with moderate-to-severe COPD who successfully complete a 12-week program of breathing retraining plus exercise will be longer than that of patients who complete a 12-week program of treadmill exercise training alone. We also hypothesized that the primary predictor of improved exercise duration will be a reduction in dynamic hyperinflation and to a lesser extent, improvement in peripheral muscle function. Lastly, we hypothesize that dyspnea will be reduced in patients assigned to breathing retraining plus exercise when compared to exercise training alone. Methods: The proposed study was a randomized controlled clinical trial. 119 patients with moderate-to-severe COPD were randomized into breathing retraining plus exercise or exercise training alone. Both groups received 12-weeks of treadmill exercise training three times weekly. The breathing retraining plus exercise group also received auditory feedback to decrease respiratory rate and prolong exhalation. The goal of breathing retraining was to reduce exercise-induced dynamic hyperinflation. Follow-up testing was completed at 6, 12, and 24 weeks. Testing included a pulmonary function test, symptom-limited and constant workrate treadmill tests, six-minute walk, dyspnea measurements, testing of respiratory muscle strength and endurance, and quadriceps muscle endurance testing. Analysis: Measures of central tendency will be used to describe the study sample. A two-sample t-test ( = 0.05) was used to analyze changes from baseline to 12-weeks between the breathing retraining plus exercise group and exercise training alone group. In data analysis, intention-to-treat principles were used. Since several measures will be taken on each patient, mixed-models analysis will be used to compare changes over time between the two groups. Multiple regression analysis will be employed to determine the predictors of improved exercise performance.

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

Primary outcomes:
measure: Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)
timeFrame: baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital
name: Eileen G. Collins, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.