Clinical trial NCT01880229: Physical Activity Monitoring in Frailty and Falling
Official title: Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fraility
Risk of Falling
Lead sponsor: BioSensics
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-06-18
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average sit-to-stand transition time over 48-hour monitoring period
timeFrame: Averaged over days 1 and 2
Secondary outcomes:
measure: Average stand-to-sit transition time during 48 hours of continuous monitoring
timeFrame: Averaged over days 1 and 2
Other outcomes:
measure: Fraility as categorized based on Fried's five phenotypic criteria
timeFrame: First evaluation (day 1)
measure: Fraility as categorized based on Fried's five phenotypic criteria
timeFrame: 6 months
Locations:
city: Tucson
country: United States
facility: University of Arizona Center on Aging
state: Arizona
city: Houston
country: United States
facility: Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance
state: Texas
Study officials:
affiliation: BioSensics
name: Joseph Gwin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Jane Mohler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.