Physical Activity Monitoring in Frailty and Falling

NCT ID: NCT01880229

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fraility Risk of Falling

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

BioSensics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Gwin, PhD

Role: PRINCIPAL_INVESTIGATOR

BioSensics

Bijan Najafi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Jane Mohler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona Center on Aging

Tucson, Arizona, United States

Site Status

Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37231977 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32930988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32375700 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28285311 (View on PubMed)

Other Identifiers

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2R42AG032748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-0659-01

Identifier Type: -

Identifier Source: org_study_id

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