Physical Activity Monitoring in Frailty and Falling

Completed

• Conditions: Risk of Falling; Fraility

• Registration Number: NCT01880229
• Lead Sponsor: BioSensics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-18
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average sit-to-stand transition time over 48-hour monitoring period	Averaged over days 1 and 2	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.

Secondary Outcome Measures

Name	Time	Method
Average stand-to-sit transition time during 48 hours of continuous monitoring	Averaged over days 1 and 2	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.

Trial Locations

Locations (2)

Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance; 🇺🇸 Houston, Texas, United States

University of Arizona Center on Aging; 🇺🇸 Tucson, Arizona, United States