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Innovation in Pulmonary Rehabilitation

Primary Purpose

Pulmonary Disease, Pulmonary Emphysema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing retraining
Heliox
Exercise
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring Breathing exercise, Exercise Therapy, Helium, Oxygen inhalation therapy, Pulmonary emphysema, Pulmonary ventilation, Rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Edward Hines, Jr. VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Breathing retraining

Heliox

Exercise

Arm Description

Exercise training with computerized training program

Exercise training with helium oxygen combination

Exercise training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 20, 2005
Last Updated
October 6, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00123422
Brief Title
Innovation in Pulmonary Rehabilitation
Official Title
Innovation Methods to Augment Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Pulmonary Emphysema
Keywords
Breathing exercise, Exercise Therapy, Helium, Oxygen inhalation therapy, Pulmonary emphysema, Pulmonary ventilation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing retraining
Arm Type
Experimental
Arm Description
Exercise training with computerized training program
Arm Title
Heliox
Arm Type
Experimental
Arm Description
Exercise training with helium oxygen combination
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Exercise training
Intervention Type
Behavioral
Intervention Name(s)
Breathing retraining
Intervention Description
exercise training with computerized training program
Intervention Type
Behavioral
Intervention Name(s)
Heliox
Intervention Description
exercise training with a helium oxygen combination
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
exercise training
Primary Outcome Measure Information:
Title
Exercise Endurance
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Inspiratory Capacity
Description
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.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen G. Collins, PhD RN
Organizational Affiliation
Edward Hines Jr. VA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24238770
Citation
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/j.rmed.2013.10.023. Epub 2013 Nov 5.
Results Reference
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Innovation in Pulmonary Rehabilitation

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