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This study will compare the effects of exercise training and breathing retraining (using metronome tones) to exercise training only. Exercise training lasts 12 weeks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | exercise training with breathing retraining |
|
| Arm 2 | Active Comparator | exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| breathing retraining | Other | breathing retraining using a metronome |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen G. Collins, PhD RN | Edward Hines Jr. VA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital | Hines | Illinois | 60141-5000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739217 | Derived | 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. |
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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.
Patients were recruited from a midwestern VA hospital and were also referred from other patients and private practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training With Breathing Retraining | treadmill exercise training plus breathing retraining using a metranome |
| FG001 | Exercise Training | treadmill exercise training |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | exercise training with breathing retraining breathing retraining: breathing retraining using a metronome exercise training: treadmill exercise training |
| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | minutes | baseline and 12 weeks |
|
Adverse events were collected over 6 months (baseline through end of study or 6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training With Breathing Retraining | treadmill exercise training plus breathing retraining using a metranome |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ischemic cerebrovascular | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment | Transischemic attack (TIA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen Collins | Edward Hines Jr., VA Hospital | 708-202-3525 | eileen.collins@va.gov |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| exercise training |
| Other |
treadmill exercise training |
|
| Withdrawal by Subject |
|
| Death |
|
exercise training
exercise training: treadmill exercise training
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| FEV1 | Mean | Standard Deviation | percent predicted |
|
| FEV1/FVC | Mean | Standard Deviation | percent |
|
| RV/TLC | Mean | Standard Deviation | percent predicted |
|
| Peak oxygen uptake | Mean | Standard Deviation | VO2 mL/kg/min |
|
| Time on treadmill constant workrate test | Mean | Standard Deviation | minutes walked |
|
treadmill exercise training |
|
|
|
| 1 |
| 58 |
| 2 |
| 58 |
| EG001 | Exercise Training | treadmill exercise training | 5 | 61 | 5 | 61 |
|
| fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Fractured rib (fall on ice) |
|
| pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | patient went to ED for muscle soreness |
|
| arterial injury-extremity lower | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment | Iliac artery aneurysm identified |
|
| infection peripheral nerve | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment | herpes zoster |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |