Clinical trial NCT03111849: Sarcopenia in COPD Patients: a French Study
Official title: Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Sarcopenia
Prevalence
Mortality
Malnutrition
Nutritional assessment
Body composition
Pulmonary cachexia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic obstructive patients

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.

Detailed description: * Investigator consecutively included patients with known persistent airflow obstruction, hospitalized in Pneumology Department at the CHU Gabriel Montpied in Clermont-Ferrand.
* Investigator offered to participate to an observational study involving nutritional evaluation (recommended by national and international authorities) complementary to their usual respiratory care, and a 6 months' follow-up consultation: examination and surveys, mid-arm muscle circumference, body composition, spirometry.
* This enables to assess sarcopenia as a low mid-arm muscle area, by measuring the mid-arm muscle circumference of the dominant side and the triceps skinfold thickness.
* The primary endpoint is to determine the prevalence of sarcopenia, via the brachial muscular circumference, of chronic obstructive patients hospitalized in Pneumology department.
* The data entry (clinical, biological and radiological) is carried out on site, during the initial consultation and follow-up, directly on the computerized patient file. These data will then be retrieved and entered in an Excel spreadsheet, anonymously (anonymous identification number, gender and age).
* Management of censored data (lost to follow-up, cessation or withdrawal of study): each patient has a "computerized patient record" with phone numbers, checked during the first consultation and updated if necessary. The patient is called back one month before the follow-up consultation to confirm the appointment. If it is impossible to come, the patient will be offered another appointment, within one month of his initial appointment.
* Lost participants will not be excluded from statistical analyses.
* The expected number of subjects is 50.
* Oral and written consent is asked at the beginning of the consultation proposing participation in the study and follow-up at 6 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of sarcopenia in hospitalized chronic obstructive patients
timeFrame: at day 1
Secondary outcomes:
measure: Evolution of sarcopenia after hospitalization
timeFrame: at day 1
measure: Determination of the factors influencing this evolution
timeFrame: at day 1
measure: Determination of phenotypes from anthropometric, functional and nutritional biological parameters
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Annick GREIL
role: PRINCIPAL_INVESTIGATOR
References: