NCT00295113

Brief Summary

The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2001

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

November 1, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

December 15, 2025

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary arterial pressureCOPDCardiac outputpulmonary and cardiac functionspulmonary arterial pressure measurements

Outcome Measures

Primary Outcomes (1)

  • The pulmonary arterial pressure does not increase dramatically during the 30 minutes exercise test, but decreases significantly after the first 5 minutes of exercise.

Secondary Outcomes (1)

  • The cardiac output is stable after the first 5 minutes of exercise, despite the high intensity work loads every 5 minutes.

Interventions

EFRPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients (male and female) with moderate obstruction (FEV1/CV\<60%)

You may not qualify if:

  • acute respiratory disease
  • any type of cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles

Strasbourg, 67091, France

Location

Related Publications (1)

  • Bougault V, Lonsdorfer-Wolf E, Charloux A, Richard R, Geny B, Oswald-Mammosser M. Does thoracic bioimpedance accurately determine cardiac output in COPD patients during maximal or intermittent exercise? Chest. 2005 Apr;127(4):1122-31. doi: 10.1378/chest.127.4.1122.

    PMID: 15821184RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ruddy RICHARD, MD

    Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice

    PRINCIPAL INVESTIGATOR

  • Evelyne LONSDORFER-WOLF, MD

    Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

February 22, 2006

Study Start

November 1, 2001

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(1)