Physical Activity Monitoring in Frailty and Falling

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01880229

Enrollment

180

Registered

2013-06-18

Start date

2012-08-31

Completion date

2018-05-31

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fraility, Risk of Falling

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Fraility as categorized based on Fried's five phenotypic criteria	First evaluation (day 1)	Fried L.P., et al. Frailty in Older Adults: Evidence for a Phenotype. Journal of Gerontology: 2001, Vol. 56A, No. 3, M146-M156

Countries

United States

Outcome results