NCT03111849

Brief Summary

The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains little studied in acute respiratory failure. Sarcopenia is a health problem representative of frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

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

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

April 7, 2017

Last Update Submit

July 25, 2018

Conditions

COPD

Keywords

COPDSarcopeniaPrevalenceMortalityMalnutritionNutritional assessmentBody compositionPulmonary cachexia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sarcopenia in hospitalized chronic obstructive patients

    at day 1

Secondary Outcomes (3)

  • Evolution of sarcopenia after hospitalization

    at day 1

  • Determination of the factors influencing this evolution

    at day 1

  • Determination of phenotypes from anthropometric, functional and nutritional biological parameters

    at day 1

Study Arms (1)

hospitalized chronic obstructive patients

Other: sarcopenia

Interventions

sarcopeniaOTHER

Prevalence of sarcopenia in hospitalized chronic obstructive patients

hospitalized chronic obstructive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic obstructive patients

You may qualify if:

  • Age ≥ 18 years
  • A history of persistent airflow obstruction (a post-bronchodilator FEV1/FVC \< 0.7 of the predicted value after 400 ug of inhaled salbutamol) compatible with respiratory function tests (according to the GOLD definition)
  • Informed consent to examination of nutritional status

You may not qualify if:

  • Bronchopulmonary cancer being treated
  • Disabling rheumatic disease
  • Recent stroke or surgery (\< 3 months)
  • Missing data on essential variables (BMI, mid-arm muscle circumference)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSarcopeniaMalnutrition

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Annick GREIL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 13, 2017

Study Start

January 1, 2017

Primary Completion

October 31, 2017

Study Completion

November 30, 2017

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

FR(1)