PEAKS: Validation of Mobile Technologies

NCT02888483 | Completed DMC

• 3 other identifiers: IRB201600822 - N5R01AG042525-05SBIR HHSN261201500014C
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

physical activity; energy expenditure

Outcome Measures

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.

  within one month

Secondary Outcomes (1)

• Tradeoff Accuracy in metabolic equivalent estimation and power consumption

  within one month

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community dwelling population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Cancer Institute (NCI): collaborator
• EveryFit, Inc: collaborator

Study Sites (1)

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Links

• University of Florida Institute on Aging

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Todd M Manini, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: July 1, 2016
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)