Innovation in Pulmonary Rehabilitation

Pulmonary Disease Clinical Trial

Official title:

Innovation Methods to Augment Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123422
• Other study ID #: F3845-R
• Status: Completed
• Phase: N/A
• First received: July 20, 2005
• Last updated: October 6, 2014
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Disease
• Pulmonary Emphysema

Intervention

Behavioral:
• Breathing retraining
exercise training with computerized training program
• Heliox
exercise training with a helium oxygen combination
• Exercise
exercise training

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No