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OpenTrials
Completed

NCT Number: NCT03111849

Sarcopenia in COPD Patients: a French Study

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

sarcopenia

Other

Prevalence of sarcopenia in hospitalized chronic obstructive patients

Primary outcomes

  1. Prevalence of sarcopenia in hospitalized chronic obstructive patients

    Time frame: at day 1

Secondary outcomes

  1. Evolution of sarcopenia after hospitalization

    Time frame: at day 1

  2. Determination of the factors influencing this evolution

    Time frame: at day 1

  3. Determination of phenotypes from anthropometric, functional and nutritional biological parameters

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: SARCOBS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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