Physical Activity Monitoring in Frailty and Falling

Risk of Falling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880229
• Other study ID #: 12-0659-01
• Secondary ID: 2R42AG032748
• Status: Completed
• Start date: August 2012
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: BioSensics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fraility
• Risk of Falling

Locations

Country	Name	City	State
United States	Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance	Houston	Texas
United States	University of Arizona Center on Aging	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
BioSensics	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fraility as categorized 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	First evaluation (day 1)
Other	Fraility as categorized 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	6 months
Primary	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	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