NCT00123422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

October 7, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

3.8 years

First QC Date

July 20, 2005

Results QC Date

October 2, 2014

Last Update Submit

October 6, 2014

Conditions

Pulmonary DiseasePulmonary Emphysema

Keywords

Breathing exerciseExercise TherapyHeliumOxygen inhalation therapyPulmonary emphysemaPulmonary ventilationRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Inspiratory Capacity

    14 weeks

Study Arms (3)

Breathing retraining

EXPERIMENTAL

Exercise training with computerized training program

Behavioral: Breathing retraining

Heliox

EXPERIMENTAL

Exercise training with helium oxygen combination

Behavioral: Heliox

Exercise

ACTIVE COMPARATOR

Exercise training

Behavioral: Exercise

Interventions

Breathing retrainingBEHAVIORAL

exercise training with computerized training program

Breathing retraining
HelioxBEHAVIORAL

exercise training with a helium oxygen combination

Heliox
ExerciseBEHAVIORAL

exercise training

Exercise

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • FEV1 70%
  • FEV1/FVC \<70%
  • RV/TLC \> 120%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Related 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/j.rmed.2013.10.023. Epub 2013 Nov 5.

    PMID: 24238770RESULT

MeSH Terms

Conditions

Lung DiseasesPulmonary Emphysema

Interventions

helioxExercise

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPulmonary Disease, Chronic ObstructiveLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Eileen Collins
Organization
Edward Hines Jr. ,VA Hospital
eileen.collins@va.gov
708-202-3525

Study Officials

  • Eileen G. Collins, PhD RN

    Edward Hines Jr. VA Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

October 16, 2014

Results First Posted

October 7, 2014

Record last verified: 2014-10

Locations

US(1)