Sarcopenia in COPD Patients: a French Study

COPD Clinical Trial

— SARCOBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111849
• Other study ID #: CHU-315
• Secondary ID: IRB00008526
• Status: Completed
• Start date: January 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: July 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 30, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Sarcopenia

Intervention

Other:
• sarcopenia
Prevalence of sarcopenia in hospitalized chronic obstructive patients

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of sarcopenia in hospitalized chronic obstructive patients		at day 1
Secondary	Evolution of sarcopenia after hospitalization		at day 1
Secondary	Determination of the factors influencing this evolution		at day 1
Secondary	Determination of phenotypes from anthropometric, functional and nutritional biological parameters		at day 1