Dynamic Lung HyperinflationHyperinflationNCT01475812
Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients
An observational study of Dynamic Lung Hyperinflation and COPD Patients, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow limitation usually progressive and associated with inflammatory response of lung noxious particles. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dynamic Lung Hyperinflation, COPD Patients, Activities of Daily Livin.
- What is being tested?
- Hyperinflation and ADL
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Hyperinflation and ADL
- Keywords
- COPD, activities of daily living, pulmonary hyperinflation, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinflation and ADLOther
Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.
| Study group | Role | What they receive |
|---|---|---|
| COPD hyperinflation | Not described Receives: Other: Hyperinflation and ADL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Lung HyperinflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio A.M. Castro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475812
- Sponsor's protocol ID
- 0353/03
- Acronym
- Hyperinflation
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT01475812
- Acronym / sponsor ID
- Hyperinflation / 0353/03
- Keywords
- COPD, activities of daily living, pulmonary hyperinflation, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD hyperinflation | – | Other: Hyperinflation and ADL |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinflation and ADLAssessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients. | Other | COPD hyperinflation |
Primary outcome
Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
Related trials for Dynamic Lung Hyperinflation
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Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
Pulmonary Disease, Chronic Obstructive
Recruiting
Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
COPD, Hyperinflation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dynamic Lung Hyperinflation and COPD Patients, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.