NCT03086590

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

March 9, 2017

Last Update Submit

November 5, 2018

Conditions

Keywords

Body compositionUltrasoundChronic Pulmonary Obstructive DiseaseRespiratory muscles

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

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

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

Locations