NCT01880229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

June 14, 2013

Last Update Submit

July 23, 2018

Conditions

FrailityRisk of Falling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Averaged over days 1 and 2

Other Outcomes (2)

  • Fraility as categorized based on Fried's five phenotypic criteria

    First evaluation (day 1)

  • Fraility as categorized based on Fried's five phenotypic criteria

    6 months

Study Arms (3)

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)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Community-dwelling ambulatory men or women ages 65 and above

You may not qualify if:

  • Mental Status Mini Exam score \< 23
  • Those who are unwilling or unable to comprehend informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona Center on Aging

Tucson, Arizona, 85719, United States

Location

Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Pradeep Kumar D, Najafi B, Laksari K, Toosizadeh N. Sensor-Based Assessment of Variability in Daily Physical Activity and Frailty. Gerontology. 2023;69(9):1147-1154. doi: 10.1159/000530900. Epub 2023 May 10.

    PMID: 37231977DERIVED

  • Pradeep Kumar D, Wendel C, Mohler J, Laksari K, Toosizadeh N. Between-day repeatability of sensor-based in-home gait assessment among older adults: assessing the effect of frailty. Aging Clin Exp Res. 2021 Jun;33(6):1529-1537. doi: 10.1007/s40520-020-01686-x. Epub 2020 Sep 15.

    PMID: 32930988DERIVED

  • Pradeep Kumar D, Toosizadeh N, Mohler J, Ehsani H, Mannier C, Laksari K. Sensor-based characterization of daily walking: a new paradigm in pre-frailty/frailty assessment. BMC Geriatr. 2020 May 6;20(1):164. doi: 10.1186/s12877-020-01572-1.

    PMID: 32375700DERIVED

  • Parvaneh S, Mohler J, Toosizadeh N, Grewal GS, Najafi B. Postural Transitions during Activities of Daily Living Could Identify Frailty Status: Application of Wearable Technology to Identify Frailty during Unsupervised Condition. Gerontology. 2017;63(5):479-487. doi: 10.1159/000460292. Epub 2017 Mar 11.

    PMID: 28285311DERIVED

Study Officials

  • Joseph Gwin, PhD

    BioSensics

    PRINCIPAL INVESTIGATOR

  • Bijan Najafi, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

  • Jane Mohler, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 18, 2013

Study Start

August 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

US(2)