Innovation in Pulmonary Rehabilitation

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Pulmonary Emphysema; Pulmonary Disease

Treatments: Behavioral: Heliox; Behavioral: Breathing retraining; Behavioral: Exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00123422

F3845-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

103 participants in 3 patient groups

Breathing retraining

Experimental group

Description:

Exercise training with computerized training program

Treatment:

Behavioral: Breathing retraining

Heliox

Experimental group

Description:

Exercise training with helium oxygen combination

Treatment:

Behavioral: Heliox

Exercise

Active Comparator group

Description:

Exercise training

Treatment:

Behavioral: Exercise