Physical Activity Monitoring in Frailty and Falling

Study Overview
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Brief Summary
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BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a single wearable motion sensor that is worn on the torso. The objectives of this observational study are the following: 1) to test the efficacy of PAMSys for objectively assessing a persons risk of falling based on activity data measured during activities of daily living and 2) to test the efficacy of PAMSys for identifying precise early physical activity or functioning indicators of frailty in those who are pre-frail or frail as compared to non-frail controls.

Official Title
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Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People

Conditions
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Fraility, Risk of Falling

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling ambulatory men or women ages 65 and above Exclusion Criteria: Mental Status Mini Exam score < 23 Those who are unwilling or unable to comprehend informed consent

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-frail<br>Categorized as non-frail based on Fried's five phenotypic criteria (Fried L.P., et al. Frailty in Older Adults: Evidence for a Phenotype. Journal of Gerontology: 2001, Vol. 56A, No. 3, M146-M156) | |
| pre-frail<br>Categorized as pre-frail based on Fried's five phenotypic criteria (Fried L.P., et al. Frailty in Older Adults: Evidence for a Phenotype. Journal of Gerontology: 2001, Vol. 56A, No. 3, M146-M156) | |
| frial<br>Categorized as frail based on Fried's five phenotypic criteria (Fried L.P., et al. Frailty in Older Adults: Evidence for a Phenotype. Journal of Gerontology: 2001, Vol. 56A, No. 3, M146-M156) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average sit-to-stand transition time over 48-hour monitoring period | Eligible subjects will receive a PAMSys motion sensors and necessary instructions for proper use. They will then wear the motion sensor continuously for 48 hours. PAMSys will record the duration of each sit-to-stand transition during this 48 hour monitoring period. The primary outcome measure is the average of these durations. | Averaged over days 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average stand-to-sit transition time during 48 hours of continuous monitoring | Eligible subjects will receive a PAMSys motion sensors and necessary instructions for proper use. They will then wear the motion sensor continuously for 48 hours. PAMSys will record the duration of each stand-to-sit transition during this 48 hour monitoring period. The primary outcome measure is the average of these durations. | Averaged over days 1 and 2 |