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Physical Activity Monitoring in Frailty and Falling

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ClinicalTrials.gov Identifier: NCT01880229
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
BioSensics

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.

Condition or disease
Fraility Risk of Falling

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Study Type : Observational [Patient Registry]
Actual Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People
Study Start Date : August 2012
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880229


Locations
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United States, Arizona
University of Arizona Center on Aging
Tucson, Arizona, United States, 85719
United States, Texas
Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance
Houston, Texas, United States, 77030
Sponsors and Collaborators
BioSensics
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Joseph Gwin, PhD BioSensics
Principal Investigator: Bijan Najafi, PhD University of Arizona
Principal Investigator: Jane Mohler, PhD University of Arizona

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BioSensics
ClinicalTrials.gov Identifier: NCT01880229     History of Changes
Other Study ID Numbers: 12-0659-01
2R42AG032748 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018