Overview

This trial is active, not recruiting.

Conditions pulmonary disease, chronic obstructive
Treatments breathing retraining, exercise training
Phase phase 2/phase 3
Sponsor Department of Veterans Affairs
Start date July 2009
End date January 2014
Trial size 246 participants
Trial identifier NCT01009099, F6955-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
exercise training with breathing retraining
breathing retraining
breathing retraining using a metronome
exercise training
treadmill exercise training
(Active Comparator)
exercise training
exercise training
treadmill exercise training

Primary Outcomes

Measure
exercise duration
time frame: baseline, 6, 12 and 24 weeks

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

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

Additional Information

Official title Reducing Dynamic Hyperinflation Through Breathing Retraining
Principal investigator Eileen G. Collins, PhD RN
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 is to develop a user-friendly ventilation-feedback technique with a novel auditory feedback system. We reason that the proposed feedback system plus exercise training will 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 hypothesize 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 is a randomized controlled clinical trial. 246 patients with moderate-to-severe COPD will be enrolled and randomized into breathing retraining plus exercise or exercise training alone. Both groups will receive 12-weeks of treadmill exercise training three times weekly. The breathing retraining plus exercise group will also receive auditory feedback to decrease respiratory rate and prolong exhalation. The goal of breathing retraining is to reduce exercise-induced dynamic hyperinflation. Follow-up testing will be completed at 6, 12, and 24 weeks. Testing will include 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) will be 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 will be 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.