Physical Activity Monitoring in Frailty and Falling

July 23, 2018 updated by: BioSensics

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona Center on Aging
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pima County Arizona elders aged 65+ will be recruited from the Arizona Center on Aging affiliated geriatrics clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
non-frail
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
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
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Averaged over days 1 and 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First evaluation (day 1)
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSensics

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Joseph Gwin, PhD, BioSensics
  • Principal Investigator: Jane Mohler, PhD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 12-0659-01
  • 2R42AG032748 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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