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CompletedNCT02888483PEAKSUpdated May 13, 2019

PEAKS: Validation of Mobile Technologies

An observational study in Health Services for Persons With Disabilities, Disability Evaluation and Exercise, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-13.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
113
Ages
60 Years and older
Sex
All
01

Study 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. 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:

  1. 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.
  2. Researchers: research-focused devices tend to be validated across a wide range of studies, but are not optimized for wearability or longitudinal use.
  3. 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.

02

Conditions studied

  • Health Services for Persons With Disabilities
  • Disability Evaluation
  • Exercise
  • Fitness Trackers
  • Validation Studies

Keywords

  • physical activity
  • energy expenditure
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Community dwelling population

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
113 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: within one month

07

Study locations

1 site
  • UF Institute on Aging Clinical and Translational Research Building
    Gainesville, Florida 32611, United States
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References and documents

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02888483
Lead sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), National Cancer Institute (NCI), EveryFit, Inc
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
Jul 2016
Primary completion
May 11, 2018
Completion
May 11, 2018
Last update
May 13, 2019

Study contacts

Todd M Manini, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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