- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475812
Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients (Hyperinflation)
November 18, 2011 updated by: Antonio A.M. Castro, Federal University of São Paulo
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo/SP
-
São Paulo, São Paulo/SP, Brazil, 05414000
- Federal University of São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COPD hyperinflation
|
Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Registration Dates
First Submitted
November 17, 2011
First Submitted That Met QC Criteria
November 18, 2011
First Posted (ESTIMATE)
November 21, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2011
Last Update Submitted That Met QC Criteria
November 18, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 0353/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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