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Reducing Dynamic Hyperinflation Through Breathing Retraining

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ClinicalTrials.gov Identifier: NCT01009099
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease COPD Other: breathing retraining Other: exercise training Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Dynamic Hyperinflation Through Breathing Retraining
Study Start Date : July 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
exercise training with breathing retraining
 Other: breathing retraining
breathing retraining using a metronome

Other: exercise training
treadmill exercise training
Active Comparator: Arm 2
exercise training
 Other: exercise training
treadmill exercise training


Outcome Measures
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Primary Outcome Measures :
  1. Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) [ Time Frame: baseline and 12 weeks ]
    The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009099


Locations
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United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Eileen G. Collins, PhD RN Edward Hines Jr. VA Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01009099    
Other Study ID Numbers: F6955-R
First Posted: November 6, 2009    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
pulmonary disease
COPD
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases