Sarcopenia in COPD Patients: a French Study (SARCOBS)

Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: sarcopenia

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

chronic obstructive patients

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hospitalized chronic obstructive patients	Other: sarcopenia; Prevalence of sarcopenia in hospitalized chronic obstructive patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of sarcopenia in hospitalized chronic obstructive patients	at day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Annick GREIL, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Prevalence; COPD; Body composition; Sarcopenia; Mortality; Malnutrition; Nutritional assessment; Pulmonary cachexia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: CHU-315; IRB00008526 (Other Identifier: IRB00008526)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No