Skip to main content
OpenTrials
Completed

NCT Number: NCT01880229

Physical Activity Monitoring in Frailty and Falling

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fraility Risk of Falling

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona Center on Aging, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Average sit-to-stand transition time over 48-hour monitoring period

    Time frame: 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 outcomes

  1. Average stand-to-sit transition time during 48 hours of continuous monitoring

    Time frame: 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 outcomes

  1. Fraility as categorized based on Fried's five phenotypic criteria

    Time frame: 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

  2. Fraility as categorized based on Fried's five phenotypic criteria

    Time frame: 6 months

    Fried L.P., et al. Frailty in Older Adults: Evidence for a Phenotype. Journal of Gerontology: 2001, Vol. 56A, No. 3, M146-M156

Sponsors and collaborators

Lead sponsor

BioSensics

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2013
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.