Recruiting

Observational Study

Sponsor:

University of Wisconsin, Milwaukee

Code:

NCT05736302

Conditions

Movement Disorders

Energy Metabolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Doubly-Labeled Water

Study Details

Brief summary:

The purpose of this study is to validate previously developed physical function-clustered specific machine-learned accelerometer algorithms to estimate total daily energy expenditure (TDEE) in individuals with general movement and functional limitations.

Conditions

Movement Disorders

Energy Metabolism

Study ID

NCT05736302

Start date

Mar 14, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • must be 18+ years of age
  • be able to ambulate on own, unassisted, on a regular basis
  • speak and read English
  • must have access to a working smart phone and a computer with internet access

Exclusion Criteria:

  • wheelchair reliant
  • assistive walking device reliant (cannot walk for at least 50 feet without an assistive device)
  • diagnosed uncontrolled hypertension (above 160/100 mgHg)
  • diagnosed cognitive impairment or inability to follow study procedures such as Alzheimer's disease or dementia
  • cannot take metabolic altering medications
  • cannot be pregnant
  • cannot be breastfeeding
  • cannot use supplemental oxygen
  • cannot completed required study activities for any reason
  • cannot have a resting heart rate > 100 bpm or a resting blood pressure > 160 mgHg during Visit 1
  • cannot weigh more than 450 lbs

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals without movement limitations

Individuals who are not classified as impaired or functionally limited per results of physical function testing.

Individuals with impaired movement

Individuals who are classified as impaired, but not functionally limited per results of physical function testing.

Individuals with impaired movement who are functionally impaired

Individuals who are classified as impaired and functionally limited per results of physical function testing.

Interventions

Doubly-Labeled Water

All eligible participants will receive a dose of doubly-labeled water.

Primary outcome measure

  • Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day). [ Time Frame: 8-10 days monitoring ]
  • Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day). [ Time Frame: 8-10 days monitoring ]
  • Total Daily Energy Expenditure (TDEE) (via DLW) [ Time Frame: pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose ]

Central Contacts and Locations

Central contacts

Katharine O'Connell Valuch

414-229-4115oconnell@uwm.edu

Scott Strath, PhD

sstrath@uwm.edu

Locations

University of Wisconsin-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53211

More Information

Sponsor

University of Wisconsin, Milwaukee

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Doubly labeled water (DLW)
  • Total Daily Energy Expenditure (TDEE)
  • Accelerometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Wisconsin, Milwaukee on 2026-05-04.