NCT00037973

Brief Summary

The primary objective of the study is to determine whether individuals with Chronic Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength program will demonstrate significantly longer exercise duration on a constant work rate treadmill test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program without ventilation-feedback or ventilation-feedback only. Secondary study objectives are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly: (a) greater exercise tolerance and aerobic power; (b) lower perception of breathlessness during progressive and constant work rate leg-cycle and treadmill exercise testing; (c) higher tidal volume and lower breathing frequency during constant work rate and at any given workload during progressive testing; (d) lower score on the Chronic Respiratory Disease Questionnaire indicating improved quality of life; (e) higher transition focal score (less dyspnea) on the Transition Dyspnea Index; (f) maintain a sustained breathing-pattern adjustment to exercise when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength program without ventilation-feedback or ventilation-feedback only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2000

Typical duration for phase_2

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

Study Start

First participant enrolled

August 1, 2000

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

May 24, 2002

Last Update Submit

September 15, 2010

Conditions

Keywords

COPDVentilation

Outcome Measures

Primary Outcomes (1)

  • Exercise endurance

    12 weeks

Study Arms (3)

1

EXPERIMENTAL

Ventilation-feedback plus exercise

Behavioral: ventilation feedbackBehavioral: exercise

2

ACTIVE COMPARATOR

Exercise

Behavioral: exercise

3

ACTIVE COMPARATOR

ventilation feedback only

Behavioral: ventilation feedback

Interventions

exerciseBEHAVIORAL
12

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic obstructive pulmonary disease

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, Langbein WE, Fehr L, O'Connell S, Jelinek C, Hagarty E, Edwards L, Reda D, Tobin MJ, Laghi F. Can ventilation-feedback training augment exercise tolerance in patients with chronic obstructive pulmonary disease? Am J Respir Crit Care Med. 2008 Apr 15;177(8):844-52. doi: 10.1164/rccm.200703-477OC. Epub 2008 Jan 17.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eileen G. Collins, PhD RN

    Edward Hines Jr. VA Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

August 1, 2000

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations