Validating a new algorithm to measure daily energy expenditure in people with movement limitations
Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
This study is testing a new device that measures how much energy people with movement limitations use in a day to see if it's more accurate than the current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Milwaukee Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05736302 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a machine-learned accelerometer algorithm designed to estimate total daily energy expenditure (TDEE) in adults with movement disorders. The current algorithms are inadequate for individuals with functional limitations, so this study will compare the new algorithm's accuracy against the doubly labeled water technique, a gold standard for measuring TDEE. Approximately 125 adults will participate, undergoing physical assessments, metabolic rate examinations, and wearing accelerometers for data collection over 8-10 days.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who can ambulate independently and have access to a smartphone and computer.
Not a fit: Patients who are wheelchair reliant, use assistive walking devices, or have uncontrolled hypertension or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for assessing energy expenditure in individuals with movement limitations, leading to better-targeted physical activity interventions.
How similar studies have performed: Other studies have shown success in validating algorithms for energy expenditure measurement, but this specific approach for individuals with movement limitations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milwaukee, Wisconsin
- University of Wisconsin-Milwaukee — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Scott Strath, PhD — University of Wisconsin, Milwaukee
- Study coordinator: Katharine O'Connell Valuch
- Email: oconnell@uwm.edu
- Phone: 414-229-4115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.