Reducing Dynamic Hyperinflation Through Breathing Retraining

COPD Clinical Trial

Official title:

Reducing Dynamic Hyperinflation Through Breathing Retraining

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009099
• Other study ID #: F6955-R
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 5, 2009
• Last updated: February 2, 2015
• Start date: July 2009
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Pulmonary Disease

Intervention

Other:
• breathing retraining
breathing retraining using a metronome
• exercise training
treadmill exercise training

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 12 weeks	No