Innovation in Pulmonary Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00123422
First received: July 20, 2005
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

The purpose of this study is 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 is an 8-week intervention study.


Condition Intervention
Pulmonary Disease
Pulmonary Emphysema
Behavioral: Breathing retraining
Behavioral: Heliox (helium-oxygen combination)
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovation Methods to Augment Pulmonary Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Exercise endurance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
exercise with oxygen
Behavioral: Breathing retraining
exercise training with computerized training program
Behavioral: Heliox (helium-oxygen combination)
exercise training with a helium oxygen combination
Behavioral: Exercise
exercise training with oxygen

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. The goal of our new proposal is to compare E+VF to E only and to compare E+Heliox to E only. We hope to provide definitive evidence whether either or both interventions are superior to E only. As a secondary objective, we will compare the two interventions "head to head" using the same rigorous research methods.

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. Next, we hypothesize that the primary mechanism/predictor responsible for the increased exercise performance in all patients will be a reduction in dynamic hyperinflation and not a difference in exercise-induced adaptation of the respiratory or peripheral muscles.

Methods: This study is a randomized controlled clinical trial. After baseline testing is completed, 135 subjects with moderate-severe COPD will be randomized into one of three groups: E+VF, E+Heliox and E training only. Follow-up testing will be completed at 8 weeks. Additionally, in order to assess carryover effects of each training program, subjects will be asked to return to the testing facility at 14 weeks for follow-up assessments. Testing will include a pulmonary function test, two symptom-limited treadmill tests, two constant work-rate tests (CWR), maximal inspiratory and expiratory pressures, respiratory muscle endurance, tissue spectrometry, quadriceps muscle endurance testing, activity monitoring, and dyspnea measurements. After baseline testing is completed, randomized subjects will train in the Physical Performance Laboratory three times weekly. Exercise prescriptions will be standardized and based on data from the exercise stress test. Measures of central tendency will be used to describe changes in physiological parameters pre-and post-treatment.

Analysis: A two-sample t-test with Bonferroni adjustment of the alpha level (a = 0.025) for each pairwise comparison will be used to analyze changes in treadmill CWR duration from baseline to 8-weeks between the E+VF and E only and the E+Heliox and training will achieve longer exercise duration than patients randomly assigned to E only groups. Multiple regression procedures will be employed to determine the predictors of improved exercise performance.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years of age
  • FEV1 70%
  • FEV1/FVC <70%
  • RV/TLC > 140%

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123422

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
Investigators
Principal Investigator: Eileen G. Collins, PhD RN Edward Hines Jr. VA Hospital
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123422     History of Changes
Other Study ID Numbers: F3845
Study First Received: July 20, 2005
Last Updated: September 7, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Breathing exercise
Exercise Therapy
Helium
Oxygen inhalation therapy
Pulmonary emphysema
Pulmonary ventilation
Rehabilitation

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014