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Sarcopenia in COPD Patients: a French Study (SARCOBS)

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

COPD

Treatments

Other: sarcopenia

Study type

Observational

Funder types

Other

Identifiers

NCT03111849
CHU-315
IRB00008526 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

54 participants in 1 patient group

hospitalized chronic obstructive patients
Treatment:
Other: sarcopenia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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