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Hines, Illinois 60141


Purpose:

The purpose of this study is to compare the effect of exercise treatment combined with breathing retraining (a computerized feedback program), with exercise treatment combined with heliox (a helium and oxygen combination), with exercise only in patients with moderate to severe chronic obstructive pulmonary disease. This is an 8-week intervention study.


Study summary:

Dynamic hyperinflation limits exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Recently, several innovative approaches have been developed to reduce the burden of dynamic hyperinflation. Two such innovations, ventilation-feedback training and Heliox supplementation during exercise show great promise and posit a reduction in dynamic hyperinflation as a key to their effectiveness. In our recently completed trial, when age, FEV1 and RV/TLC were controlled, exercise plus VF (E+VF) was superior to E training alone (E only) or VF training alone in improving exercise tolerance. The mechanism responsible for this difference was, in part, a reduction in exercise-induced dynamic hyperinflation secondary to a change in breathing pattern. In additional preliminary studies, we determined that exercise tolerance can be increased when patients exercise while inhaling Heliox. Similar to VF, the mechanism for exercise improvement with Heliox was a reduction in exercise-induced dynamic hyperinflation. Although both interventions are promising, there are no definitive data to support use of either intervention as a standard of care for pulmonary rehabilitation. The goal of our new proposal is to compare E+VF to E only and to compare E+Heliox to E only. We hope to provide definitive evidence whether either or both interventions are superior to E only. As a secondary objective, we will compare the two interventions "head to head" using the same rigorous research methods. Hypothesis/Research Questions Overview: The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of (a) E+VF training will achieve longer exercise duration than patients randomly assigned to E only and (b) E+heliox training will achieve longer exercise duration than patients randomly assigned to E only. Next, we hypothesize that the primary mechanism/predictor responsible for the increased exercise performance in all patients will be a reduction in dynamic hyperinflation and not a difference in exercise-induced adaptation of the respiratory or peripheral muscles. Methods: This study is a randomized controlled clinical trial. After baseline testing is completed, 135 subjects with moderate-severe COPD will be randomized into one of three groups: E+VF, E+Heliox and E training only. Follow-up testing will be completed at 8 weeks. Additionally, in order to assess carryover effects of each training program, subjects will be asked to return to the testing facility at 14 weeks for follow-up assessments. Testing will include a pulmonary function test, two symptom-limited treadmill tests, two constant work-rate tests (CWR), maximal inspiratory and expiratory pressures, respiratory muscle endurance, tissue spectrometry, quadriceps muscle endurance testing, activity monitoring, and dyspnea measurements. After baseline testing is completed, randomized subjects will train in the Physical Performance Laboratory three times weekly. Exercise prescriptions will be standardized and based on data from the exercise stress test. Measures of central tendency will be used to describe changes in physiological parameters pre-and post-treatment.


Criteria:

Inclusion Criteria: - 40 years of age - FEV1 70% - FEV1/FVC <70% - RV/TLC > 120% Exclusion Criteria: - Respiratory infection/exacerbation within last 4 weeks - Exercise limiting heart disease - Primary asthma - Congestive heart failure New York Heart Association (NYHA) Class III-IV - Exercise limiting peripheral arterial disease or arthritis - Inability to walk on a treadmill


Study is Available At:


Original ID:

F3845-R


NCT ID:

NCT00123422


Secondary ID:


Study Acronym:


Brief Title:

Innovation in Pulmonary Rehabilitation


Official Title:

Innovation Methods to Augment Pulmonary Rehabilitation


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

192


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eileen G. Collins, PhD RN
Principal Investigator
Edward Hines Jr. VA Hospital

Study Dates

Start Date:October 2005
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:October 1, 2014
First Received Date:July 20, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Exercise endurance
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Breathing retraining
Description:exercise training with computerized training program
Arm Name:Breathing retraining
Intervention Type:Behavioral
Name:Heliox (helium-oxygen combination)
Description:exercise training with a helium oxygen combination
Arm Name:Heliox
Intervention Type:Behavioral
Name:Exercise
Description:exercise training
Arm Name:Exercise

Study Arms

Study Arm Type:Active Comparator
Arm Name:Exercise
Description:Exercise training
Study Arm Type:Experimental
Arm Name:Heliox
Description:Exercise training with helium oxygen combination
Study Arm Type:Experimental
Arm Name:Breathing retraining
Description:Exercise training with computerized training program

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Collins EG, Jelinek C, O'Connell S, Butler J, McBurney C, Gozali C, Reda D, Laghi F. Contrasting breathing retraining and helium-oxygen during pulmonary rehabilitation in COPD: a randomized clinical trial. Respir Med. 2014 Feb;108(2):297-306. doi: 10.1016/j.rmed.2013.10.023. Epub 2013 Nov 5.
PMID:24238770

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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