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Reducing Dynamic Hyperinflation Through Breathing Retraining

Primary Purpose

Pulmonary Disease, COPD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
breathing retraining
exercise training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring pulmonary disease, COPD

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward Hines, Jr. VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

exercise training with breathing retraining

exercise training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2009
Last Updated
February 2, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01009099
Brief Title
Reducing Dynamic Hyperinflation Through Breathing Retraining
Official Title
Reducing Dynamic Hyperinflation Through Breathing Retraining
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, COPD
Keywords
pulmonary disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
exercise training with breathing retraining
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
exercise training
Intervention Type
Other
Intervention Name(s)
breathing retraining
Intervention Description
breathing retraining using a metronome
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
treadmill exercise training
Primary Outcome Measure Information:
Title
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen G. Collins, PhD RN
Organizational Affiliation
Edward Hines Jr. VA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30739217
Citation
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.
Results Reference
derived

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Reducing Dynamic Hyperinflation Through Breathing Retraining

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