- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086590
EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
November 5, 2018 updated by: Rodrigo Viana Correia de Souza, Universidade Federal de Pernambuco
BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD
Study Overview
Status
Completed
Conditions
Detailed Description
Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality.
A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018.
As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.
Study Type
Observational
Enrollment (Actual)
20
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
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Pernambuco
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Recife, Pernambuco, Brazil, 50670-901
- Universidade Federal de Pernambuco
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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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with Chronic Obstructive Pulmonary Disease, selected at the Hospital das Clínicas of the Federal University of Pernambuco, Hospital Otávio de Freitas and Pharmacy of the State of Pernambuco.
Description
Inclusion Criteria:
- Young adults, adults and elderly subjects
Exclusion Criteria:
- Others respiratory diseases;
- Heart diseases;
- Those who are in some previous training program or rehabilitation;
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 |
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Group 1
COPD mild.
The individuals allocated to this group have FEV1 ≥ 80% predicted.
|
Group 2
COPD Moderate.
The individuals allocated to this group have 50% ≤ FEV1 < 80% predicted.
|
Group 3
COPD Severe.
The individuals allocated to this group have 30% ≤ FEV1 < 50% predicted.
|
Group 4
COPD Very severe.
The individuals allocated to this group have FEV1 < 30% predicted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat-free mass
Time Frame: Baseline
|
Mass of the human body disregarding fat.
|
Baseline
|
Quadriceps Force
Time Frame: Baseline
|
Quadriceps muscle strength measured during maximum voluntary contraction.
|
Baseline
|
Handgrip strength
Time Frame: Baseline
|
Maximum voluntary manual holding force.
|
Baseline
|
Total chest wall volume
Time Frame: Baseline
|
Total volume resulting from the sum of the volume of the pulmonary compartment of the costal, abdominal gradient of the costal and abdominal beds.
|
Baseline
|
Oxygen uptake
Time Frame: Baseline
|
Consumption of oxygen during an effort.
|
Baseline
|
Diaphragm mobility
Time Frame: Baseline
|
It is the diaphragmatic movement from the end of the expiration until the end of the inspiration, being able to be realized in tidal volume or starting from the total pulmonary capacity.
|
Baseline
|
Diaphragm thickness
Time Frame: Baseline
|
Defined as a corpulence of the diaphragm muscle
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
November 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFPE-M1
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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