The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD

NCT00406705 | Completed Phase 2

• 1 other identifier: MSI 824
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease; COPD; Emphysema; Lung Diseases; Bronchitis, Chronic

Keywords

Exercise Tolerance; Dyspnea; Rehabilitation; Helium

Outcome Measures

Primary Outcomes (1)

• Constant-load exercise tolerance after 6 weeks of exercise rehabilitation

Secondary Outcomes (3)

• Maximum oxygen consumption after 6 weeks of exercise rehabilitation

• Quality of Life measured after 6 weeks of exercise rehabilitation

• Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation

Interventions

Helium-Hyperoxia BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV1/FVC\<70% predicted;
• FEV1\<70% predicted;
• RV\>140% predicted.

You may not qualify if:

• Cardiovascular contraindications to exercise;
• Musculoskeletal abnormalities that limit exercise tolerance;
• SpO2\<85% during a constant work rate test;
• On supplemental oxygen.
• Exacerbation within the last month

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Caritas Centre for Lung Health

Edmonton, Alberta, T5K 0L4, Canada

Location

Related Publications (2)

• Eves ND, Petersen SR, Haykowsky MJ, Wong EY, Jones RL. Helium-hyperoxia, exercise, and respiratory mechanics in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Oct 1;174(7):763-71. doi: 10.1164/rccm.200509-1533OC. Epub 2006 Jul 13.

  PMID: 16840742 BACKGROUND

• Eves ND, Sandmeyer LC, Wong EY, Jones LW, MacDonald GF, Ford GT, Petersen SR, Bibeau MD, Jones RL. Helium-hyperoxia: a novel intervention to improve the benefits of pulmonary rehabilitation for patients with COPD. Chest. 2009 Mar;135(3):609-618. doi: 10.1378/chest.08-1517. Epub 2008 Nov 18.

  PMID: 19017883 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Lung Diseases; Bronchitis, Chronic; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Neil D Eves, PhD

  University of Calgary, AB, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: March 1, 2005
• Study Completion: January 1, 2007
• Last Updated: May 4, 2007

Record last verified: 2007-03

Locations

CA (1)