Health Services for Persons With DisabilitiesPEAKSNCT02888483
PEAKS: Validation of Mobile Technologies
An observational study of Health Services for Persons With Disabilities and Disability Evaluation, run by University of Florida at 1 site in United States.
Trial summary
The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. This is a cross-sectional validation study of 100 apparently health community dwelling adults aged 60+ years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Services for Persons With Disabilities, Disability Evaluation, Exercise
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 11 May 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling population
Who may be able to join
- Age 60+ years old
- Community dwelling adults without significant health issues that would impact safety of participation
- Willingness to undergo all testing procedures
- Weight stable for at least three months
- Able to understand and speak English
Who cannot join
- Failure to provide informed consent
- Use of walker (use of a cane is permitted)
- Lower extremity amputation
- Develops chest pain or severe shortness of breath during physical stress
- Post-stroke syndrome causing ambulatory deficits (other stroke survivors permitted)
- Needs assistance with basic activities of daily living: feeding, dressing, continence, bathing, toileting, and transferring from a bed to a chair or from a chair to walking
Show all 23Show fewer
- Lives in a nursing home; persons living in assisted or independent housing are not excluded
- Heavy drinking as drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days.
- For women who are child-bearing age (up to 62 years of age): pregnancy or breast-feeding
- Participation in a structured weight loss program or fad diet in the last month
- Weight reduction surgery in the past year
- Known neuromuscular disorder that restricts activity (e.g. Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, etc.)
- Diagnosed neuropathy that causes pain that restricts activity
- Symptomatic peripheral arterial disease that restricts activity
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment, which would preclude completion of the assessments
- Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, Multiple Sclerosis, ALS)
- Severe rheumatologic or orthopedic diseases that significantly restricts activity (e.g., awaiting joint replacement, active inflammatory disease)
- Terminal illness, as determined by a physician
- Severe pulmonary disease, requiring the use of supplemental oxygen or steroid therapy
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Other significant comorbid disease discovered during medical screening that would elicit safety concerns, (e.g. renal failure on hemodialysis, psychiatric disorder, chronic fatigue syndrome, etc.)
- Pacemakers and implanted cardiac defibrillators
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
Official title: PEAKS: Validation of Mobile Technologies for Clinical Assessment, Monitoring and Intervention
The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. This is a cross-sectional validation study of 100 apparently health community dwelling adults aged 60+ years. Participants will perform standardized lifestyle, exercise and sedentary type physical activities in a clinic laboratory and home setting.
Read the detailed description
Wearable activity monitors have the potential to continuously and objectively measure physical activity. However, existing monitors do not address the unique challenges that face older adults, who comprise the largest segment of population who suffer from physical disabilities and dexterity issues that can make using such monitors exceedingly difficult. In fact, the majority of wearable devices on the market address the needs of three broad segments:
- Consumers: these devices are designed and optimized for motivated, healthy younger individuals and require pairing with smartphones to transmit data, while restricting or, at best, limiting access to raw data and algorithms.
- Researchers: research-focused devices tend to be validated across a wide range of studies, but are not optimized for wearability or longitudinal use.
- Developers: Developer-focused devices typically provide high configurability, a high- definition screen, and a variety of sensors (e.g. accelerometer, gyroscope, air pressure, light, temperature, etc.) that are suited for research and development, but are not optimized for power-efficient use.
To overcome the barriers that existing monitors impose on measuring free-living physical activity data, EveryFit developed in-home activity monitoring technology that addresses the specific and unique needs of the older population (incorporated in product called QMedic).
The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. The technology utilizes novel power-efficient engineering to continuously measure physical activity (including intensity, type and duration) in both laboratory and free-living settings. To accomplish this objective we will enroll 100 adults 60+ years of age who will perform standardized lifestyle, exercise and sedentary type physical activity in the laboratory. A subset of participants will also be asked to wear the monitor in free-living settings.
The proposed work can have far-reaching impact given the growth in the older adult population, which suffers disproportionally from chronic disease and functional impairments. Validating technology that measures physical activity continuously and accurately at the home is a critical step in scaling the system, conducting affordable population- scale studies, and maximizing the societal impact of the innovation.
- Conditions
- Health Services for Persons With Disabilities, Disability Evaluation, Exercise, Fitness Trackers, Validation Studies
- Keywords
- physical activity, energy expenditure
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic equivalent (MET) value
MET value of physical activities defined as the oxygen uptake (VO2 = milliliter• min-1•kg-1) during a steady state rate expressed as a function 3.5 milliliter• min-1•kg-1.
Measured: within one month
Secondary outcomes (1)
Tradeoff Accuracy in metabolic equivalent estimation and power consumption
We will manipulate the state machine that samples data from the device with different duty cycles based on contextual changes as measured by the accelerometer or classified by models that use the accelerometer data to classify behavior or categories of behavior.
Measured: within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for Persons With DisabilitiesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Cancer Institute (NCI), EveryFit, Inc
- Responsible party
- Sponsor
- Investigators
- Todd M Manini, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888483
- Sponsor's protocol ID
- IRB201600822 - N
- Other IDs
- 5R01AG042525-05, SBIR HHSN261201500014C
- Acronym
- PEAKS
- Status last verified
- May 2019
- First submitted
- 30 Aug 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEAKS: Validation of Mobile Technologies for Clinical Assessment, Monitoring and Intervention
- ClinicalTrials.gov ID
- NCT02888483
- Acronym / sponsor ID
- PEAKS / IRB201600822 - N
- Conditions
- Health Services for Persons With Disabilities, Disability Evaluation, Exercise, Fitness Trackers, Validation Studies
- Keywords
- physical activity, energy expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Cancer Institute (NCI), EveryFit, Inc
- Study start
- Jul 2016 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 5 Sep 2016 (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.
The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. This is a cross-sectional validation study of 100 apparently health community dwelling adults aged 60+ years. Participants will perform standardized lifestyle, exercise and sedentary type physical activities in a clinic laboratory and home setting.
Detailed description
Wearable activity monitors have the potential to continuously and objectively measure physical activity. However, existing monitors do not address the unique challenges that face older adults, who comprise the largest segment of population who suffer from physical disabilities and dexterity issues that can make using such monitors exceedingly difficult. In fact, the majority of wearable devices on the market address the needs of three broad segments:
- Consumers: these devices are designed and optimized for motivated, healthy younger individuals and require pairing with smartphones to transmit data, while restricting or, at best, limiting access to raw data and algorithms.
- Researchers: research-focused devices tend to be validated across a wide range of studies, but are not optimized for wearability or longitudinal use.
- Developers: Developer-focused devices typically provide high configurability, a high- definition screen, and a variety of sensors (e.g. accelerometer, gyroscope, air pressure, light, temperature, etc.) that are suited for research and development, but are not optimized for power-efficient use.
To overcome the barriers that existing monitors impose on measuring free-living physical activity data, EveryFit developed in-home activity monitoring technology that addresses the specific and unique needs of the older population (incorporated in product called QMedic).
The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. The technology utilizes novel power-efficient engineering to continuously measure physical activity (including intensity, type and duration) in both laboratory and free-living settings. To accomplish this objective we will enroll 100 adults 60+ years of age who will perform standardized lifestyle, exercise and sedentary type physical activity in the laboratory. A subset of participants will also be asked to wear the monitor in free-living settings.
The proposed work can have far-reaching impact given the growth in the older adult population, which suffers disproportionally from chronic disease and functional impairments. Validating technology that measures physical activity continuously and accurately at the home is a critical step in scaling the system, conducting affordable population- scale studies, and maximizing the societal impact of the innovation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling population
Key inclusion criteria (5 listed)
- Age 60+ years old
- Community dwelling adults without significant health issues that would impact safety of participation
- Willingness to undergo all testing procedures
- Weight stable for at least three months
- Able to understand and speak English
Key exclusion criteria (23 listed)
- Failure to provide informed consent
- Use of walker (use of a cane is permitted)
- Lower extremity amputation
- Develops chest pain or severe shortness of breath during physical stress
- Post-stroke syndrome causing ambulatory deficits (other stroke survivors permitted)
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
Metabolic equivalent (MET) value
Time frame: within one month
MET value of physical activities defined as the oxygen uptake (VO2 = milliliter• min-1•kg-1) during a steady state rate expressed as a function 3.5 milliliter• min-1•kg-1.
1 secondary outcome
Tradeoff Accuracy in metabolic equivalent estimation and power consumption
Time frame: within one month
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 13 May 2019.
- University of Florida Institute on AgingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Todd M Manini, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services for Persons With Disabilities and Disability Evaluation, run by University of Florida at 1 site 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 5 inclusion and 23 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Metabolic equivalent (MET) value (time frame: within one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2019.