EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
1 other identifier
observational
20
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
1 active site
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
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedNovember 7, 2018
November 1, 2018
1.3 years
March 9, 2017
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Fat-free mass
Mass of the human body disregarding fat.
Baseline
Quadriceps Force
Quadriceps muscle strength measured during maximum voluntary contraction.
Baseline
Handgrip strength
Maximum voluntary manual holding force.
Baseline
Total chest wall volume
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
Consumption of oxygen during an effort.
Baseline
Diaphragm mobility
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
Defined as a corpulence of the diaphragm muscle
Baseline
Study Arms (4)
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.
Eligibility Criteria
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.
You may qualify if:
- Young adults, adults and elderly subjects
You may not qualify if:
- Others respiratory diseases;
- Heart diseases;
- Those who are in some previous training program or rehabilitation;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 22, 2017
Study Start
November 1, 2016
Primary Completion
February 1, 2018
Study Completion
March 1, 2018
Last Updated
November 7, 2018
Record last verified: 2018-11