NCT00870246

Brief Summary

The purpose of this study is to evaluate the influence of diaphragm mobility on exercise capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

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

February 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

3 months

First QC Date

March 26, 2009

Last Update Submit

May 5, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDpulmonary emphysema

Outcome Measures

Primary Outcomes (1)

  • spirometer, capacity of exercise, dyspnea

    3 months

Secondary Outcomes (1)

  • diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound

    1 year

Study Arms (2)

1

High mobility

2

Lower mobility

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sixty patients with moderate or severe COPD were evaluated.

You may qualify if:

  • patients with chronic obstructive pulmonary disease clinically stable (no respiratory crises or hospitalizations within the 30 days preceding the study outset)
  • patients receiving optimized clinical medical treatment

You may not qualify if:

  • patients suffering from other cardiorespiratory diseases
  • patients with oxygen-dependent for any reason
  • patients classified as obese or as underweight
  • patients presenting other respiratory diseases or pleural scars on chest X-rays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

  • Celso Carvalho, professor

    Sao Paulo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

November 1, 2008

Last Updated

May 6, 2009

Record last verified: 2009-05