Innovation in Pulmonary Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innovation Methods to Augment Pulmonary Rehabilitation

Conditions
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Pulmonary Disease, Pulmonary Emphysema

Intervention / Treatment
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* Behavioral: Breathing retraining
* Behavioral: Heliox
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing retraining<br>Exercise training with computerized training program | Behavioral: Breathing retraining<br>* exercise training with computerized training program<br>|
| Experimental: Heliox<br>Exercise training with helium oxygen combination | Behavioral: Heliox<br>* exercise training with a helium oxygen combination<br>|
| Active Comparator: Exercise<br>Exercise training | Behavioral: Exercise<br>* exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance | 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. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory Capacity | 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. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing exercise, Exercise Therapy, Helium, Oxygen inhalation therapy, Pulmonary emphysema, Pulmonary ventilation, Rehabilitation