跳至主要内容
临床试验/NCT06644859
NCT06644859进行中(未招募)不适用

Data Analysis to Evaluate Which Specific Gait Measures Are Associated with Risk of Injurious Falls

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 17,466 人开始时间: 2024年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
17,466
试验地点
1
主要终点
Association of Gait Speed with Risk of Injurious Falls (AIM1)

研究概览

简要总结

The goal of this study is to understand if specific gait and activity measures can help predict injurious falls in older women. The main questions it aims to answer are:

Can combining daily gait (DLG) and daily physical activity (DLPA) measures more accurately predict the risk of injurious falls? How effective is wearable technology and machine learning in analyzing these activity measures for fall prediction? Researchers will analyze data from the Women's Health Study (WHS), using wearable technology to track daily walking patterns and physical activity, and apply machine learning to assess the likelihood of harmful falls.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

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

入选标准

  • after menopause or without intention of pregnancy

排除标准

  • history of CHD, cerebrovascular disease, cancer (except non-melanoma skin cancer), or other serious illness;
  • history of serious side effects to study treatments;
  • taking aspirin, drugs containing aspirin, or non-steroidal anti-inflammatory drugs > once a week, or ready to give up the use of these drugs;
  • taking anticoagulants or corticosteroids;
  • Taking vitamin A, E or ß-carotene supplements > once a week.

结局指标

主要结局

Association of Gait Speed with Risk of Injurious Falls (AIM1)

时间窗: njurious falls within 1 year after baseline assessment using time-to-event analyses.

The study will evaluate the association between gait speed (measured in meters per second) and the risk of injurious falls within one year following the accelerometer assessment.

Association of Cadence with Risk of Injurious Falls (AIM1)

时间窗: Injurious falls within 1 year after baseline assessment using time-to-event analyses.

The study will assess the association between cadence (measured in steps per minute) and the risk of injurious falls within one year following the accelerometer assessment.

Association of Gait Variability with Risk of Injurious Falls (AIM1)

时间窗: Time Frame: Injurious falls within 1 year after baseline assessment using time-to-event analyses.

The study will assess the association between gait variability (measured as the standard deviation of step times) and the risk of injurious falls within one year following the accelerometer assessment.

Association of Overall Activity Levels with Risk of Injurious Falls (AIM2)

时间窗: Injurious falls within 1 year after baseline assessment using time-to-event analyses

The study will evaluate the association between overall activity levels (measured in average accelerometer counts per minute) and the risk of injurious falls within one year following the baseline assessment.

Association of Activity Fragmentation with Risk of Injurious Falls (AIM2)

时间窗: Injurious falls within 1 year after baseline assessment using time-to-event analyses.

The study will assess the association between activity fragmentation (measured by the fragmentation index) and the risk of injurious falls within one year following the baseline assessment.

Combined DLG and DLPA Measure for Predicting Risk of Injurious Falls (AIM3)

时间窗: Time Frame: Injurious falls within 1 year after baseline assessment, using combined predictive models.

his outcome will evaluate a single combined score derived from both daily life gait (DLG) and daily life physical activity (DLPA) measures to assess the association with the risk of injurious falls. The combined score will be created incorporating DLG measures (e.g., gait speed, variability) and DLPA measures (e.g., overall activity levels, fragmentation) into a unified predictor.

次要结局

  • Association of Self-Reported Exercise History with Gait Speed(Assessed at baseline (self-reported exercise history) and at the time of accelerometer data collection, with data analyzed within 1 year of the baseline assessment.)
  • Association of Self-Reported Exercise History with Gait Variability(Assessed at baseline (self-reported exercise history) and at the time of accelerometer data collection, with data analyzed within 1 year of the baseline assessment)
  • Association of Self-Reported Exercise History with Overall Activity Levels(Assessed at baseline (self-reported exercise history) and at the time of accelerometer data collection, with data analyzed within 1 year of the baseline assessment)
  • Association of Self-Reported Exercise History with Activity Fragmentation(Assessed at baseline (self-reported exercise history) and at the time of accelerometer data collection, with data analyzed within 1 year of the baseline assessment)
  • Association of Gait Speed with Risk of Injurious Falls (Over 5 Years)(5 years after baseline.)
  • Association of Gait Variability with Risk of Injurious Falls (Over 5 Years)(5 years after baseline.)
  • Association of Overall Activity Levels with Risk of Injurious Falls (Over 5 Years)(5 years after baseline.)
  • Association of Activity Fragmentation with Risk of Injurious Falls (Over 5 Years)(5 years after baseline.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验