NCT01475812

Brief Summary

Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow limitation usually progressive and associated with inflammatory response of lung noxious particles. During a physical activity chronic obstructive pulmonary disease patients may develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity performance. The investigators hypothesize that some specific activities of daily living induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung hyperinflation and its influence in dyspnea perception in moderate and severe chronic obstructive pulmonary disease patients after activities of daily living. Methods: The investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation, heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients. These measurements were taken at rest and after daily living activities (such as going up and down a set of stairs, going up and down a ramp and sweeping and mopping a room).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

First QC Date

November 17, 2011

Last Update Submit

November 18, 2011

Conditions

Keywords

COPDactivities of daily livingpulmonary hyperinflationexercise

Outcome Measures

Primary Outcomes (1)

  • Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.

    3 months

Study Arms (1)

COPD hyperinflation

Other: Hyperinflation and ADL

Interventions

Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.

COPD hyperinflation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators included 19 COPD patients (13 male) with moderate to very severe degree of airway obstruction, with a mean post bronchodilator forced expiratory volume in the first second (FEV1) of 48.7 ± 7.1% predicted and mean age of 64.1 ± 5.3.

You may qualify if:

  • COPD patients diagnosed with moderate to very severe airway obstruction according to GOLD classification (9)
  • clinical stability with no clinical exacerbation during the previous 30 days prior to the beginning of the study and to sign an informed consent form

You may not qualify if:

  • Inability to perform the slow vital capacity maneuver
  • excessive perceived dyspnea during the test
  • arterial oxyhemoglobin saturation (SpO2) lower than 80% during activities and/or need of oxygen supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo/SP, 05414000, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 21, 2011

Study Start

March 1, 2007

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations