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Pulmonary Disease, Chronic ObstructivePhase 2NCT00037973

Effect of Ventilation-Feedback Training on Exercise Performance in COPD

A Phase 2 study testing ventilation feedback and exercise in people with Pulmonary Disease, Chronic Obstructive, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to determine whether individuals with Chronic Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength program will demonstrate significantly longer exercise duration on a constant… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
ventilation feedback and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
Aug 2000to Aug 2003
Phase
Phase 2
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with chronic obstructive pulmonary disease

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141-5000

Other trials in United States

About this study

Official title: Effects of Ventilation-Feedback Training on Exercise Performance in COPD

The primary objective of the study is to determine whether individuals with Chronic Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength program will demonstrate significantly longer exercise duration on a constant work rate treadmill test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program without ventilation-feedback or ventilation-feedback only. Secondary study objectives are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly: (a) greater exercise tolerance and aerobic power; (b) lower perception of breathlessness during progressive and constant work rate leg-cycle and treadmill exercise testing; (c) higher tidal volume and lower breathing frequency during constant work rate and at any given workload during progressive testing; (d) lower score on the Chronic Respiratory Disease Questionnaire indicating improved quality of life; (e) higher transition focal score (less dyspnea) on the Transition Dyspnea Index; (f) maintain a sustained breathing-pattern adjustment to exercise when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength program without ventilation-feedback or ventilation-feedback only.

Read the detailed description

Statement of the Problem: Chronic obstructive pulmonary disease (COPD) is a term used to characterize those individuals with chronic bronchitis or emphysema who have obstruction to airflow on a spirogram. 1) Patients with COPD have a poor exercise capacity that is reflective of their underlying disease. 2) The symptoms of lung disease triggered by simple low-intensity activities of daily living such as dressing and undressing, bathing and shopping are insufferable, consequently these patients become sedentary. An increasingly sedentary lifestyle leads to muscle deconditioning making physical activity even more intolerable. 3) The cycle continues in a downward spiral. Pulmonary rehabilitation is essential to assist persons with COPD to cope with their disease. The two primary objectives of pulmonary rehabilitation are to control and alleviate the symptoms of the respiratory illness and to assist the patient toward optimal capabilities in carrying out his/her activities of daily living. 4) The proposed study will evaluate the efficacy of a unique program of ventilation-feedback training combined with leg-cycle and walking exercise to improve exertional endurance, perceived dyspnea and quality of life in persons with COPD.

Hypothesis: Individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill constant work rate (CWR) exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training or a ventilation-feedback training only program.

Specific Objectives:

Short-term Objectives- The primary objective of the proposed study is to determine whether individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill CWR exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program without ventilation-feedback or a ventilation-feedback program only. The secondary objectives of the proposed research are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training or ventilation-feedback only program will, when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program only, demonstrate significantly: (a) greater work tolerance and aerobic power on maximal leg-cycle and treadmill exercise tests; (b) lower perception of breathlessness during progressive and CWR leg-cycle and treadmill exercise tests; (c) significantly higher tidal volume (VT) and lower breathing frequency during CWR and at any given workload on the progressive leg-cycle and treadmill exercise tests; (d) lower score on the Chronic Respiratory Disease Questionnaire (CRDQ)5 indicating better quality of life; and (e) higher transition focal score on the Transition Dyspnea Index (TDI).6 In addition, six weeks after completing the training program all subjects will repeat the treadmill CWR test. This will be done to assess whether the positive effects of the ventilation-feedback training persist beyond the 12-week training period.

Long-term Objectives: If our hypothesis is correct, we will use the ventilation-feedback technique to teach a more efficient breathing pattern during activities of daily living. In time, the system will be miniaturized and portable thereby making this new technique readily usable during pulmonary rehabilitation.

Being tested
ventilation feedback, exercise
Keywords
COPD, Ventilation
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ventilation feedbackBehavioural

  • exerciseBehavioural

Study groups in NCT00037973
Study groupRoleWhat they receive
1ExperimentalVentilation-feedback plus exercise
Receives: Behavioral: ventilation feedback; Behavioral: exercise
2Active comparatorExercise
Receives: Behavioral: exercise
3Active comparatorventilation feedback only
Receives: Behavioral: ventilation feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise endurance

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2002 (estimated)
  2. Study startAug 2000
  3. Primary completionAug 2003
  4. Study completionAug 2003

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00037973
Sponsor's protocol ID
F2302
Status last verified
Sep 2010
First submitted
24 May 2002
Last updated
16 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • Collins EG, Langbein WE, Fehr L, O'Connell S, Jelinek C, Hagarty E, Edwards L, Reda D, Tobin MJ, Laghi F. Can ventilation-feedback training augment exercise tolerance in patients with chronic obstructive pulmonary disease? Am J Respir Crit Care Med. 2008 Apr 15;177(8):844-52. doi: 10.1164/rccm.200703-477OC. Epub 2008 Jan 17.

    PubMed 18202351

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ventilation feedback and exercise in people with Pulmonary Disease, Chronic Obstructive, 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 1 inclusion and 0 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 16 Sep 2010. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 endurance (time frame: 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 NCT00037973, 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 16 Sep 2010; AzTrials last refreshed its copy on 29 Oct 2026.

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