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Reducing Dynamic Hyperinflation Through Breathing Retraining

Reducing Dynamic Hyperinflation Through Breathing Retraining

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009099
Enrollment
119
Registered
2009-11-06
Start date
2009-07-31
Completion date
2015-01-31
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Pulmonary Disease

Keywords

pulmonary disease, COPD

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.

Interventions

breathing retraining using a metronome

OTHERexercise training

treadmill exercise training

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)baseline and 12 weeksThe primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from a midwestern VA hospital and were also referred from other patients and private practices.

Pre-assignment details

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.

Participants by arm

ArmCount
Arm 1
exercise training with breathing retraining breathing retraining: breathing retraining using a metronome exercise training: treadmill exercise training
58
Arm 2
exercise training exercise training: treadmill exercise training
61
Total119

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall StudyLost to Follow-up10
Overall StudyPhysician Decision32
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicTotalArm 1Arm 2
Age, Continuous66.0 years
STANDARD_DEVIATION 8
65.8 years
STANDARD_DEVIATION 7.9
66.3 years
STANDARD_DEVIATION 8.1
Body Mass Index29.7 kg/m2
STANDARD_DEVIATION 6.5
30.0 kg/m2
STANDARD_DEVIATION 6.7
29.3 kg/m2
STANDARD_DEVIATION 6.2
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
118 Participants57 Participants61 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
FEV143.8 percent predicted
STANDARD_DEVIATION 14.3
43.7 percent predicted
STANDARD_DEVIATION 14.9
44.0 percent predicted
STANDARD_DEVIATION 13.9
FEV1/FVC45.8 percent
STANDARD_DEVIATION 12.7
46.6 percent
STANDARD_DEVIATION 13.3
45.1 percent
STANDARD_DEVIATION 12.1
Peak oxygen uptake16.1 VO2 mL/kg/min
STANDARD_DEVIATION 3.6
15.7 VO2 mL/kg/min
STANDARD_DEVIATION 3.9
16.6 VO2 mL/kg/min
STANDARD_DEVIATION 3.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
30 Participants16 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
89 Participants42 Participants47 Participants
Region of Enrollment
United States
119 participants58 participants61 participants
RV/TLC169.7 percent predicted
STANDARD_DEVIATION 28.4
171.3 percent predicted
STANDARD_DEVIATION 30.3
168.2 percent predicted
STANDARD_DEVIATION 26.6
Sex: Female, Male
Female
6 Participants4 Participants2 Participants
Sex: Female, Male
Male
113 Participants54 Participants59 Participants
Time on treadmill constant workrate test6.9 minutes walked
STANDARD_DEVIATION 2.4
6.8 minutes walked
STANDARD_DEVIATION 2.5
6.9 minutes walked
STANDARD_DEVIATION 2.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 585 / 61
serious
Total, serious adverse events
1 / 585 / 61

Outcome results

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.

Time frame: baseline and 12 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Exercise Training With Breathing RetrainingExercise Duration (Time Walked on the Constant Workrate Treadmill Test)15.2 minutesStandard Deviation 14.8
Exercise TrainingExercise Duration (Time Walked on the Constant Workrate Treadmill Test)17.6 minutesStandard Deviation 14.1
Comparison: The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.p-value: 0.63ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026