NCT03111849已完成不适用
Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Prevalence of sarcopenia in hospitalized chronic obstructive patients
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Bronchopulmonary cancer being treated
- •Disabling rheumatic disease
- •Recent stroke or surgery (< 3 months)
- •Missing data on essential variables (BMI, mid-arm muscle circumference)
结局指标
主要结局
Prevalence of sarcopenia in hospitalized chronic obstructive patients
时间窗: at day 1
次要结局
- 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)
研究者
研究点 (1)
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