Movement DisordersValiDLWNCT05736302
Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
An observational study of Movement Disorders and Energy Metabolism, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders, Energy Metabolism
- What is being tested?
- Doubly-Labeled Water
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 18+ years of age
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Scott Strath, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
Katharine O'Connell Valuch
Scott Strath
About this study
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.
Read the detailed description
Current algorithms for examining accelerometer data were developed primarily using data from individuals without movement limitations or impairments. As such, the current available analytic algorithms are inadequate for use with individuals with limitations and impairments to estimate total daily energy expenditure (TDEE). The creation of a new algorithm that can accurately assess TDEE in individuals with movement limitations will be beneficial for future research examining physical activity interventions targeted to these individuals. This study will serve to validate a new algorithm that was developed specifically to analyze accelerometer data for individuals with movement limitations, and gauge the accuracy of the new algorithm's ability to accurately assess TDEE against one of the gold standards of TDEE measurement, the doubly labelled water technique.
Approximately 125 adults, 50 from Colorado, and 75 from Wisconsin, will participate in this study. Participants will complete three study visits. During the first visit, physical function will be assessed during a series of tests, and a dual-energy X-ray absorptiometry (DXA) scan will be performed to obtain information on body composition. During the second visit, the participant will complete a resting metabolic rate (RMR) examination, will consume a dose of doubly labeled water, and will provide urine and saliva samples. At the end of the second visit, participants will be given a set of accelerometers to wear for 8-10 days, and will be asked to complete a wear log for documentation. After 8-10 days have passed, during the final visit, participants will provide additional urine samples and return the accelerometers.
The hypothesis being tested is that physical function-clustered specific machine-learned accelerometer algorithms will produce more accurate and precise estimations of TDEE during free-living compared with healthy population derived accelerometer algorithms applied to diverse populations.
- Conditions
- Movement Disorders, Energy Metabolism
- Being tested
- Doubly-Labeled Water
- Keywords
- Doubly labeled water (DLW), Total Daily Energy Expenditure (TDEE), Accelerometry
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doubly-Labeled WaterOther
All eligible participants will receive a dose of doubly-labeled water.
| Study group | Role | What they receive |
|---|---|---|
| Individuals without movement limitations | Individuals who are not classified as impaired or functionally limited per results of physical function testing. Receives: Other: Doubly-Labeled Water | |
| Individuals with impaired movement | Individuals who are classified as impaired, but not functionally limited per results of physical function testing. Receives: Other: Doubly-Labeled Water | |
| Individuals with impaired movement who are functionally impaired | Individuals who are classified as impaired and functionally limited per results of physical function testing. Receives: Other: Doubly-Labeled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.
Measured: 8-10 days monitoring
Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.
Measured: 8-10 days monitoring
Total Daily Energy Expenditure (TDEE) (via DLW)
Total daily energy expenditure (TDEE) over the 8-10 day period as measured by the difference in presence of isotopes in the samples at Visit 3. The 18-O and deuterium exit the body through slightly different mechanisms, so when we examine the difference in levels present at the end of the 8-10 day period between Visit 2 and Visit 3, we can estimate carbon dioxide (CO2) production and hence, energy expenditure. The samples taken at Visit 2 provide the baseline information required to analyze the samples taken at Visit 3 and calculate TDEE.
Measured: pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose
Secondary outcomes (6)
Resting Metabolic Rate (kcals/day)
Basal metabolic rate as determined by fasting RMR test, conducted via Parvomedics TrueOne 2400 Metabolic system. Results include the approximate number of calories an individual would expend if they spent the day in a resting state.
Measured: pre-dose
Fat free body mass (g)
Dual x-ray absorptiometry (DEXA) measurement of body composition, conducted via a Hologic Horizon W system. Results include the amount of fat, bone mineral density, and fat free mass, measured in grams. The fat free mass measurement is used to calculate the dose of doubly labeled water for the participant.
Measured: 7-14 days before dose
Modified Physical Performance Test (MPPT)
The modified physical performance test consists of 9 subtests that are used to assess level of physical function. Total scores range from 0-36. Not frail = 32-36, Mildly frail = 25-31, Moderately frail = 17-24, and less than 17= low function.
Measured: 7-14 days before dose
Maximum hand grip strength
Hand grip is measured via a hand grip dynamometer manufactured by Lafayette Instruments, and is equivalent to the Jamar hand grip dynamometer. The results are measured in lbs, and can range from 0 lbs to 250 lbs. Cut offs for normal hand grip strength vary significantly dependent upon age, sex, country of origin, and BMI. Lower hand grip strength is associated with lower physical function.
Measured: 7-14 days before dose
Gait speed
Gait speed is measured via the 10 meter walk test, with three repetitions of the test at a normal walking speed, and three repetitions of the test at a fast walking speed. A number of different published cut-offs exist for this test, but a cut-off of 1.0 m/sec is recognized as being an indicator of lower physical function. Individuals who ambulate slower than 1.0 m/sec are at risk of not being able to function in the community.
Measured: 7-14 days before dose
Temporospatial gait analysis
Analysis of gait to determine whether anomalies are present via the GAITrite system. Over 50 variables are taken into account in the analysis. These results are compared to standardized norms (sex and age based), and elements of the analysis that are abnormal compared to those norms are indicated in the system output.
Measured: 7-14 days before dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start14 Mar 2023
- Primary completion28 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Massachusetts, Amherst, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Scott Strath, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736302
- Sponsor's protocol ID
- 21.061
- Other IDs
- R01CA215318
- Acronym
- ValiDLW
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Following completion of the study, all accrued data will be handled and collated in a manner consistent to allow for dissemination of generated data sets to qualified researchers in the scientific community for further analyses and study.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
- ClinicalTrials.gov ID
- NCT05736302
- Acronym / sponsor ID
- ValiDLW / 21.061
- Conditions
- Movement Disorders, Energy Metabolism
- Keywords
- Doubly labeled water (DLW), Total Daily Energy Expenditure (TDEE), Accelerometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Massachusetts, Amherst, National Cancer Institute (NCI)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current algorithms for examining accelerometer data were developed primarily using data from individuals without movement limitations or impairments. As such, the current available analytic algorithms are inadequate for use with individuals with limitations and impairments to estimate total daily energy expenditure (TDEE). The creation of a new algorithm that can accurately assess TDEE in individuals with movement limitations will be beneficial for future research examining physical activity interventions targeted to these individuals. This study will serve to validate a new algorithm that was developed specifically to analyze accelerometer data for individuals with movement limitations, and gauge the accuracy of the new algorithm's ability to accurately assess TDEE against one of the gold standards of TDEE measurement, the doubly labelled water technique.
Approximately 125 adults, 50 from Colorado, and 75 from Wisconsin, will participate in this study. Participants will complete three study visits. During the first visit, physical function will be assessed during a series of tests, and a dual-energy X-ray absorptiometry (DXA) scan will be performed to obtain information on body composition. During the second visit, the participant will complete a resting metabolic rate (RMR) examination, will consume a dose of doubly labeled water, and will provide urine and saliva samples. At the end of the second visit, participants will be given a set of accelerometers to wear for 8-10 days, and will be asked to complete a wear log for documentation. After 8-10 days have passed, during the final visit, participants will provide additional urine samples and return the accelerometers.
The hypothesis being tested is that physical function-clustered specific machine-learned accelerometer algorithms will produce more accurate and precise estimations of TDEE during free-living compared with healthy population derived accelerometer algorithms applied to diverse populations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals without movement limitations | – | Other: Doubly-Labeled WaterIndividuals who are not classified as impaired or functionally limited per results of physical function testing. |
| Individuals with impaired movement | – | Other: Doubly-Labeled WaterIndividuals who are classified as impaired, but not functionally limited per results of physical function testing. |
| Individuals with impaired movement who are functionally impaired | – | Other: Doubly-Labeled WaterIndividuals who are classified as impaired and functionally limited per results of physical function testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18+ years of age
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doubly-Labeled WaterAll eligible participants will receive a dose of doubly-labeled water. | Other | Individuals with impaired movement, Individuals with impaired movement who are functionally impaired, Individuals without movement limitations |
Primary outcome
Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Time frame: 8-10 days monitoring
Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.
Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Time frame: 8-10 days monitoring
Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.
Total Daily Energy Expenditure (TDEE) (via DLW)
Time frame: pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose
Total daily energy expenditure (TDEE) over the 8-10 day period as measured by the difference in presence of isotopes in the samples at Visit 3. The 18-O and deuterium exit the body through slightly different mechanisms, so when we examine the difference in levels present at the end of the 8-10 day period between Visit 2 and Visit 3, we can estimate carbon dioxide (CO2) production and hence, energy expenditure. The samples taken at Visit 2 provide the baseline information required to analyze the samples taken at Visit 3 and calculate TDEE.
6 secondary outcomes
Resting Metabolic Rate (kcals/day)
Time frame: pre-dose
Fat free body mass (g)
Time frame: 7-14 days before dose
Modified Physical Performance Test (MPPT)
Time frame: 7-14 days before dose
Maximum hand grip strength
Time frame: 7-14 days before dose
Gait speed
Time frame: 7-14 days before dose
Temporospatial gait analysis
Time frame: 7-14 days before dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided. Following completion of the study, all accrued data will be handled and collated in a manner consistent to allow for dissemination of generated data sets to qualified researchers in the scientific community for further analyses and study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Strath, PhD contact
Scott Strath, PhD principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Energy Metabolism, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharine O'Connell Valuch (414-229-4115, oconnell@uwm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day). (time frame: 8-10 days monitoring). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.