FrailityNCT01880229
Physical Activity Monitoring in Frailty and Falling
An observational study of Fraility and Risk of Falling, run by BioSensics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fraility, Risk of Falling
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to May 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Pima County Arizona elders aged 65+ will be recruited from the Arizona Center on Aging affiliated geriatrics clinics.
Who may be able to join
- Community-dwelling ambulatory men or women ages 65 and above
Who cannot join
- Mental Status Mini Exam score < 23
- Those who are unwilling or unable to comprehend informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine Interdisciplinary Consortium on Advance Motion Performance
Houston, Texas, 77030
University of Arizona Center on Aging
Tucson, Arizona, 85719
About this study
Official title: 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.
- Conditions
- Fraility, Risk of Falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Averaged over days 1 and 2
Secondary outcomes (1)
Average stand-to-sit transition time during 48 hours of continuous monitoring
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.
Measured: Averaged over days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joseph Gwin, PhD, Principal investigator, BioSensicsBijan Najafi, PhD, Principal investigator, University of ArizonaJane Mohler, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880229
- Sponsor's protocol ID
- 12-0659-01
- Other IDs
- 2R42AG032748
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2013
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37231977Pradeep 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.
PubMed 32930988Pradeep 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.
PubMed 32375700Parvaneh 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.
PubMed 28285311
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People
- ClinicalTrials.gov ID
- NCT01880229
- Acronym / sponsor ID
- 12-0659-01
- Conditions
- Fraility, Risk of Falling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2012
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Pima County Arizona elders aged 65+ will be recruited from the Arizona Center on Aging affiliated geriatrics clinics.
Key inclusion criteria (1 listed)
- Community-dwelling ambulatory men or women ages 65 and above
Key exclusion criteria (2 listed)
- Mental Status Mini Exam score < 23
- Those who are unwilling or unable to comprehend informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Average stand-to-sit transition time during 48 hours of continuous monitoring
Time frame: Averaged over days 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 37231977Pradeep 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.
- Derived from this study: PubMed 32930988Pradeep 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.
- Derived from this study: PubMed 32375700Pradeep 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.
- Derived from this study: PubMed 28285311Parvaneh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Gwin, PhD principal investigator
BioSensics
Bijan Najafi, PhD principal investigator
University of Arizona
Jane Mohler, PhD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fraility and Risk of Falling, run by BioSensics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average sit-to-stand transition time over 48-hour monitoring period (time frame: Averaged over days 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880229, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.