NCT02129855

Brief Summary

The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

4.9 years

First QC Date

February 28, 2014

Last Update Submit

June 6, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    Participants will attend up to 4 visits within one month of enrollment to attain these data

  • Metabolic economy

    Metabolic economy is the energy expended for a given work rate.

    Participants will attend up to 4 visits within one month of enrollment to attain these data

  • Relative metabolic cost to peak energy expenditure

    Relative metabolic cost is function of peak oxygen consumption

    Participants will attend up to 4 visits within one month of enrollment to attain these data

  • Relative metabolic cost to resting energy expenditure

    Relative metabolic cost as a function of resting

    Participants will attend up to 4 visits within one month of enrollment to attain these data

Secondary Outcomes (1)

  • Rating of perceived exertion

    Participants will attend up to 4 visits within one month of enrollment to attain these data

Other Outcomes (1)

  • Accelerometer signals to predict of energy expenditure

    Participants will attend up to 4 visits within one month of enrollment to attain these data

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community dwelling population

You may qualify if:

  • Age 20+ years old
  • Community dwelling adults without significant health issues
  • 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
  • A 10% enrollment limit will be applied to avid exercisers in each age decade. Avid exercises will be defined as doing structured exercise 3 or more days per week (e.g. jogging, sports etc., walkers will be permitted in the study). Based on our experience, avid exercisers volunteer for this type of research at a high rate and thus the investigators will limit these individuals to prevent a biased comparison
  • 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)
  • Pacemaker
  • 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
  • For adults over the age of 60: \>2 errors on the Short, portable mental status questionnaire administered after written informed consent
  • Excessive alcohol or substance abuse within six months or consumption of \>14 alcohol drinks/week
  • For women who are child-bearing age (up to 62 years of age): pregnant 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 (Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, chronic fatigue syndrome etc.)
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Links

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

February 28, 2014

First Posted

May 2, 2014

Study Start

July 1, 2014

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations