Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123422
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2005-07-20
Brief Title:
Innovation in Pulmonary Rehabilitation
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Innovation Methods to Augment Pulmonary Rehabilitation
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was 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 was an 8-week intervention study
Detailed Description:
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 RVTLC were controlled exercise plus VF EVF 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
HypothesisResearch Questions Overview The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of a EVF training will achieve longer exercise duration than patients randomly assigned to E only and b Eheliox training will achieve longer exercise duration than patients randomly assigned to E only
Methods This study was a randomized controlled clinical trial After baseline testing is completed 103 subjects with moderate-severe COPD were randomized into one of three groups EVF EHeliox and E training only Follow-up testing was completed at 8 weeks testing activity monitoring and dyspnea measurements After baseline testing was completed randomized subjects trained in the Physical Performance Laboratory three times weekly Exercise prescriptions were standardized and based on data from the exercise stress test
HypothesisResearch Questions Overview The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of a EVF training will achieve longer exercise duration than patients randomly assigned to E only and b Eheliox training will achieve longer exercise duration than patients randomly assigned to E only
Methods This study was a randomized controlled clinical trial After baseline testing is completed 103 subjects with moderate-severe COPD were randomized into one of three groups EVF EHeliox and E training only Follow-up testing was completed at 8 weeks testing activity monitoring and dyspnea measurements After baseline testing was completed randomized subjects trained in the Physical Performance Laboratory three times weekly Exercise prescriptions were standardized and based on data from the exercise stress test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None