跳至主要内容
临床试验/NCT04366388
NCT04366388
招募中
不适用

Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

University of British Columbia2 个研究点 分布在 1 个国家目标入组 120 人2022年6月1日

概览

阶段
不适用
干预措施
ActivPAL3 VT (PAL Technologies Ltd).
疾病 / 适应症
Frail Elderly Syndrome
发起方
University of British Columbia
入组人数
120
试验地点
2
主要终点
Total standing time
状态
招募中
最后更新
昨天

概览

简要总结

The major purpose of this study is to establish the use of daily step counts as inexpensive, easy to measure marker for frailty and sarcopenia in an inpatient population of older adults.

详细描述

The total time involved to complete study procedures will be between 2-3 hours at your enrollment and up to 10 minutes at your discharge. Investigators will invite participants to enrol in this study at your admission and discharge days. Firstly, Investigators would like to collect some demographic data, including participants age and gender. Then Investigators will ask participants to check their blood pressure and heart rate, weight, height and Body Mass Index. Also Investigators will collect participant's medication List and Past Medical History. Then, Investigators would like to ask participants to carry special device on their mid-thigh. It's called 'ActivPAL' and a trained research assistant will fit it on participant's dominant leg. This device has ability to detect the joint angle of participant's thigh to capture lying, sitting, standing, and stepping activities. Then Investigators will proceed to ultrasound test. Participants will be asked to lay down on the bed with their legs supported by a pillow. Then a study physician will use ultrasound to measure participant's leg muscles. Three measurements will be taken for each participant. After that participant will be asked to do a "Grip test". Participant will be asked to squeeze special device, called dynamometer, using your dominant hand. Each participant will be asked to make three attempts with half a minute break between each measurement. Participant will be asked to walk 10-15 meters in order to measure their gait speed. Impedance measures of body composition will be performed using an automatic scale. At the end Investigators will ask you to measure participant's body structure, using skinfold/caliper device. At participant discharge Investigators will remove 'ActivPal' sensor from their leg that was fitted at enrollment.

注册库
clinicaltrials.gov
开始日期
2022年6月1日
结束日期
2026年12月1日
最后更新
昨天
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kenneth Madden

Principal Investigator

University of British Columbia

入排标准

入选标准

  • be 65 years of age or older
  • be admitted in ACE Unit

排除标准

  • be less than 65 years of age
  • be nonambulatory
  • be diagnosed with end-stage organ failure (end-stage COPD, renal failure requiring dialysis, end-stage heart failure)

研究组 & 干预措施

Frail hospitalized old adults

Over than 65-years of age Admitted into Acute Unit Nonambulatory

干预措施: ActivPAL3 VT (PAL Technologies Ltd).

结局指标

主要结局

Total standing time

时间窗: 2 weeks or shorter

Total upright time will show a strong association with both continuous measures of frailty (Clinical Frailty Scale) and the presence of sarcopenia, as measured by ultrasound and bioelectric impedance measures.

次要结局

  • Daily step counts(2 weeks or shorter)

研究点 (2)

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