Innovation in Pulmonary Rehabilitation
- Conditions
- Pulmonary DiseasePulmonary Emphysema
- Interventions
- Behavioral: Breathing retrainingBehavioral: ExerciseBehavioral: Heliox
- Registration Number
- NCT00123422
- Lead Sponsor
- US Department of Veterans Affairs
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 40 years of age
- FEV1 70%
- FEV1/FVC <70%
- RV/TLC > 120%
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breathing retraining Breathing retraining Exercise training with computerized training program Exercise Exercise Exercise training Heliox Heliox Exercise training with helium oxygen combination
- Primary Outcome Measures
Name Time Method Exercise Endurance 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.
- Secondary Outcome Measures
Name Time Method Inspiratory Capacity 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.
Trial Locations
- Locations (1)
Edward Hines, Jr. VA Hospital
🇺🇸Hines, Illinois, United States