Pulmonary DiseasePhase 2/3NCT01009099
Reducing Dynamic Hyperinflation Through Breathing Retraining
A Phase 2/3 study testing breathing retraining and exercise training in people with Pulmonary Disease and COPD, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Pulmonary Disease, COPD
- What is being tested?
- breathing retraining and exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
About this study
This study will compare the effects of exercise training and breathing retraining (using metronome tones) to exercise training only. Exercise training lasts 12 weeks.
Read the 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.
- Conditions
- Pulmonary Disease, COPD
- Being tested
- breathing retraining, exercise training
- Keywords
- pulmonary disease, COPD
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing retrainingOther
breathing retraining using a metronome
exercise trainingOther
treadmill exercise training
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | exercise training with breathing retraining Receives: Other: breathing retraining; Other: exercise training |
| Arm 2 | Active comparator | exercise training Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eileen G. Collins, PhD RN, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009099
- Sponsor's protocol ID
- F6955-R
- Status last verified
- Feb 2015
- First submitted
- 5 Nov 2009
- Last updated
- 18 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30739217
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Dynamic Hyperinflation Through Breathing Retraining
- ClinicalTrials.gov ID
- NCT01009099
- Acronym / sponsor ID
- F6955-R
- Conditions
- Pulmonary Disease, COPD
- Keywords
- pulmonary disease, COPD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: breathing retraining, Other: exercise trainingexercise training with breathing retraining |
| Arm 2 | Active comparator | Other: exercise trainingexercise training |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 yr of age
- FEV1 70%
- FEV1/FVC < 70%
- RV/TLC 120%
- mean SpO2 90% at peak exercise (w/ or w/o O2)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathing retrainingbreathing retraining using a metronome | Other | Arm 1 |
| exercise trainingtreadmill exercise training | Other | Arm 1, Arm 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30739217Collins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen G. Collins, PhD RN principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing breathing retraining and exercise training in people with Pulmonary Disease and COPD, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01009099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.