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Innovation in Pulmonary Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123422
First Posted: July 22, 2005
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
July 20, 2005
July 22, 2005
October 2, 2014
October 7, 2014
October 16, 2014
October 2005
August 2009   (Final data collection date for primary outcome measure)
Exercise Endurance [ Time Frame: 14 weeks ]
Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.
Exercise endurance on a constant workrate treadmill test at 8 weeks
Complete list of historical versions of study NCT00123422 on ClinicalTrials.gov Archive Site
Inspiratory Capacity [ Time Frame: 14 weeks ]
Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.
Change in inspiratory and perceived dyspnea at 8 weeks; carryover effect of treatment at 14 weeks.
Not Provided
Not Provided
 
Innovation in Pulmonary Rehabilitation
Innovation Methods to Augment Pulmonary Rehabilitation
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.

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.

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.

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: E+VF, E+Heliox 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Disease
  • Pulmonary Emphysema
  • Behavioral: Breathing retraining
    exercise training with computerized training program
  • Behavioral: Heliox
    exercise training with a helium oxygen combination
  • Behavioral: Exercise
    exercise training
  • Experimental: Breathing retraining
    Exercise training with computerized training program
    Intervention: Behavioral: Breathing retraining
  • Experimental: Heliox
    Exercise training with helium oxygen combination
    Intervention: Behavioral: Heliox
  • Active Comparator: Exercise
    Exercise training
    Intervention: Behavioral: Exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
September 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00123422
F3845-R
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Eileen G. Collins, PhD RN Edward Hines Jr. VA Hospital
VA Office of Research and Development
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP