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临床试验/NCT04140331
NCT04140331终止不适用

Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
202
试验地点
1
主要终点
Mean daily preoperative walking activity (average of steps/day over a period of 7 days)

研究概览

简要总结

Short term morbidity after elective cardiac surgery remains significant. Standard predictive models, considering simple patient demographics and clinical parameters, show limited efficiency in individual operative risk assessment. There is growing evidence about daily physical activity as a relevant indicator of preoperative "frailty". Although cardiopulmonary exercise testing remains a gold standard, we are looking for more simple tools in order to identify patients with poor physical condition. Accelerometry may be an objective and reproductible method to measure physical activity at patient's home.

详细描述

The aim of this study is to compare accelerometer-assessed preoperative physical activity between two groups of patients with different postoperative length of stay following elective cardiac surgery. In the future, accelerometry could be used to identify patients that may benefit from prehabilitation programs including exercise therapy before elective cardiac surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult subject (≥ 60 years) awaiting elective cardiac surgery
  • Patients affiliated or entitled to a social security scheme
  • Patients who have received information about the study and have given their oral consent to participate

排除标准

  • Pregnant woman,
  • Major limitations in physical activity for orthopedic or musculoskeletal reasons
  • Patients under judicial protection (curator or guardianship)

结局指标

主要结局

Mean daily preoperative walking activity (average of steps/day over a period of 7 days)

时间窗: Day: 7

Measured by accelerometry.

次要结局

  • Time of very intense activity in hours per week (hours/week)(Day: 7)
  • Postoperative clinical outcome and duration of stay in intensive care(Months: 26)
  • Low activity time in hours per week (hours/week)(Day: 7)
  • Sleep time in hours per week (hours/week)(Day: 7)
  • Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days(Day: 7)
  • Total energy expenditure evaluated over a 7 days (steps/day)(Day: 7)
  • Moderate activity time in hours per week (hours/week)(Day: 7)
  • Intense activity time in hours per week (hours/week)(Day: 7)
  • Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days(Day: 7)
  • Dosage of albumin (g/L)(Day: 7)
  • Dosage of prealbumin (g/L)(Day: 7)
  • Preoperative strength assessed by dynamometry (Kg)(Day: 14)
  • Preoperative clinical outcome and duration of stay in intensive care(Months: 26)
  • Relationship between preoperative physical activity and duration of stay in intensive care(Months: 26)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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