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

Active, not recruiting

• Conditions: Women; Age ≥45; After Menopause or Without Intention of Pregnancy

• Registration Number: NCT06644859
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-06
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2030-08-01
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 17466

Inclusion Criteria

• after menopause or without intention of pregnancy

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of Gait Speed with Risk of Injurious Falls (AIM1)	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)	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)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
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.	This outcome will assess whether participants' self-reported exercise history is associated with gait speed (measured in meters per second) derived from accelerometer data.
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	This outcome will evaluate whether participants' self-reported exercise history is associated with gait variability (measured as the standard deviation of step times) derived from accelerometer data.
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	This outcome will assess whether participants' self-reported exercise history is associated with overall activity levels (measured in accelerometer counts per minute) derived from accelerometer data.
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	his outcome will evaluate whether participants' self-reported exercise history is associated with activity fragmentation (measured by the fragmentation index) derived from accelerometer data.
Association of Gait Speed with Risk of Injurious Falls (Over 5 Years)	5 years after baseline.	This outcome will assess whether gait speed (measured in meters per second) is associated with the risk of injurious falls over a 5-year follow-up period.
Association of Gait Variability with Risk of Injurious Falls (Over 5 Years)	5 years after baseline.	This outcome will assess whether gait variability (measured as the standard deviation of step times) is associated with the risk of injurious falls over a 5-year follow-up period.
Association of Overall Activity Levels with Risk of Injurious Falls (Over 5 Years)	5 years after baseline.	This outcome will evaluate whether overall activity levels (measured in accelerometer counts per minute) are associated with the risk of injurious falls over a 5-year follow-up period.
Association of Activity Fragmentation with Risk of Injurious Falls (Over 5 Years)	5 years after baseline.	This outcome will assess whether activity fragmentation (measured by the fragmentation index) is associated with the risk of injurious falls over a 5-year follow-up period.

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel