COPD, Pulmonary Disease
Conditions
Keywords
pulmonary disease, COPD
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.
Interventions
breathing retraining using a metronome
treadmill exercise training
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) | baseline and 12 weeks | The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from a midwestern VA hospital and were also referred from other patients and private practices.
Pre-assignment details
204 patients signed informed consents and were screened for participation in the study. 85 patients did not meet eligibility criteria for the following reasons: PFT results did not meet study criteria, claudication, cardiac issues, non-compliance, changed their mind, and active substance use. 119 patients were enrolled in the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 exercise training with breathing retraining
breathing retraining: breathing retraining using a metronome
exercise training: treadmill exercise training | 58 |
| Arm 2 exercise training
exercise training: treadmill exercise training | 61 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Arm 1 | Arm 2 |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 8 | 65.8 years STANDARD_DEVIATION 7.9 | 66.3 years STANDARD_DEVIATION 8.1 |
| Body Mass Index | 29.7 kg/m2 STANDARD_DEVIATION 6.5 | 30.0 kg/m2 STANDARD_DEVIATION 6.7 | 29.3 kg/m2 STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 57 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| FEV1 | 43.8 percent predicted STANDARD_DEVIATION 14.3 | 43.7 percent predicted STANDARD_DEVIATION 14.9 | 44.0 percent predicted STANDARD_DEVIATION 13.9 |
| FEV1/FVC | 45.8 percent STANDARD_DEVIATION 12.7 | 46.6 percent STANDARD_DEVIATION 13.3 | 45.1 percent STANDARD_DEVIATION 12.1 |
| Peak oxygen uptake | 16.1 VO2 mL/kg/min STANDARD_DEVIATION 3.6 | 15.7 VO2 mL/kg/min STANDARD_DEVIATION 3.9 | 16.6 VO2 mL/kg/min STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 16 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 89 Participants | 42 Participants | 47 Participants |
| Region of Enrollment United States | 119 participants | 58 participants | 61 participants |
| RV/TLC | 169.7 percent predicted STANDARD_DEVIATION 28.4 | 171.3 percent predicted STANDARD_DEVIATION 30.3 | 168.2 percent predicted STANDARD_DEVIATION 26.6 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 113 Participants | 54 Participants | 59 Participants |
| Time on treadmill constant workrate test | 6.9 minutes walked STANDARD_DEVIATION 2.4 | 6.8 minutes walked STANDARD_DEVIATION 2.5 | 6.9 minutes walked STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 58 | 5 / 61 |
| serious Total, serious adverse events | 1 / 58 | 5 / 61 |
Outcome results
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.
Time frame: baseline and 12 weeks
Population: Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Training With Breathing Retraining | Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) | 15.2 minutes | Standard Deviation 14.8 |
| Exercise Training | Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) | 17.6 minutes | Standard Deviation 14.1 |