Innovation in Pulmonary Rehabilitation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-09-30

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.

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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.

Conditions

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Pulmonary Disease Pulmonary Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Breathing retraining

Exercise training with computerized training program

Group Type EXPERIMENTAL

Breathing retraining

Intervention Type BEHAVIORAL

exercise training with computerized training program

Heliox

Exercise training with helium oxygen combination

Group Type EXPERIMENTAL

Heliox

Intervention Type BEHAVIORAL

exercise training with a helium oxygen combination

Exercise

Exercise training

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

exercise training

Interventions

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Breathing retraining

exercise training with computerized training program

Intervention Type BEHAVIORAL

Heliox

exercise training with a helium oxygen combination

Intervention Type BEHAVIORAL

Exercise

exercise training

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No