NCT01303913

Brief Summary

Oxygen desaturation (SO2 \< 88-90%) during walking is a common clinical feature of Chronic Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to evaluate anthropometric and functional characteristics of COPD patients correlated with oxygen desaturation during Six-minute walking test (6MWT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

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

June 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

February 28, 2011

Status Verified

February 1, 2011

First QC Date

February 24, 2011

Last Update Submit

February 25, 2011

Conditions

COPD

Keywords

COPDOxygen desaturationWalking test

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation nadir (SO2 nadir)

    Measured by change in percentage (%)

    Measured at the end of 6MWT

Study Arms (2)

Walking desaturation group

COPD patients that at the end of 6MWT have SO2 nadir \<88-90%

Walking No-desaturation group

COPD patients that at the end of 6MWT have SO2 nadir \>88-90%

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients

You may qualify if:

  • COPD patients
  • Ability to perform 6MWT
  • Normal oxygen saturation at rest and at the begin of 6MWT

You may not qualify if:

  • No-COPD patients
  • Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
  • Any co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villa Pineta Hospital

Pavullo nel Frignano, Modena, 41026, Italy

Location

Related Publications (1)

  • Crisafulli E, Iattoni A, Venturelli E, Siscaro G, Beneventi C, Cesario A, Clini EM. Predicting walking-induced oxygen desaturations in COPD patients: a statistical model. Respir Care. 2013 Sep;58(9):1495-503. doi: 10.4187/respcare.02321. Epub 2013 Jan 29.

    PMID: 23362168DERIVED

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

  • Ernesto Crisafulli, MD, PhD

    Villa Pineta Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

June 1, 2010

Study Completion

February 1, 2011

Last Updated

February 28, 2011

Record last verified: 2011-02

Locations

IT(1)