Sarcopenia in COPD Patients: a French Study

NCT ID: NCT03111849

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-11-30

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.

Conditions

COPD

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

hospitalized chronic obstructive patients

sarcopenia

Intervention Type: OTHER

Prevalence of sarcopenia in hospitalized chronic obstructive patients

Interventions

sarcopenia

Prevalence of sarcopenia in hospitalized chronic obstructive patients

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annick GREIL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

IRB00008526

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-315

Identifier Type: -

Identifier Source: org_study_id