Physical ActivityMOVENCT07270185
Measuring Outcomes With Validated Exercise
An observational study of Physical Activity, run by Boston University at 1 site in United States.
Trial summary
Physical activity and its intensity level is a critical determinant of health. Digital Health Technologies, such as wearable accelerometers (wrist-worn watch-like devices), can provide researchers and clinicians with objective measures of activity intensity, duration, and effect on an individual's physiology which can… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Physical Activity
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to 4 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will come from patients who receive care at Boston Medical Center or on the Boston University Medical Campus and who reply to posted flyers about the research study. It is anticipated that about 80 healthy interested individuals 18-89 years old (half 18-59 and half 60-89) will be enrolled and after attrition ultimately data from 54 will be analyzed for the sample.
Who may be able to join
- Participant is willing and able to comply with study instructions, study visits, and procedures including wearing a tight-fitting respiratory mask
- Able to ambulate independently, including walking/running on a treadmill without assistance.
- Demonstrates fluency in English
- Montreal Cognitive Assessment (MoCA) score of ≥26
- Score of 100 on the Barthel Index
- Participant has reliable access to internet
Who cannot join
- Participation in other digital device trials within 1 week or investigational drug trials within 5 half-lives of last dose.
- Allergy to polyurethane resin (strap/wristband component), silicone rubber, nickel and/or steel.
- Has any planned surgical, dental, or medical procedure that would overlap with study participation.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at intake that precludes participant's participation in study activities including any self-reported diagnosis of cardiovascular disease, metabolic disorder, chronic obstructive pulmonary disease, cerebral vascular accident/stroke, stage 2 hypertension, use of any medication which alters heart rate (HR) response (e.g., Beta blockers and calcium blockers), any history of myocardial infarction high-risk unstable angina, uncontrolled cardiac arrhythmias, active endocarditis, symptomatic severe aortic stenosis, decompensated symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, acute noncardiac disorder that my affect exercise performance/be worsened by exercise (e.g., infection, renal failure), acute myocarditis or pericarditis, left main coronary stenosis or its equivalent, moderate stenotic valvular heart disease, electrolyte abnormalities, tachyarrhythmia or bradyarrhythmia's, atrial fibrillation, high-degree Atrioventricular (AV) block, mobility/orthopedic limitations.
- Has any skin conditions, open wounds, or other conditions on the wrists that may interfere with wrist-worn wearable sensors.
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- Has tuberculosis, oral lesions (sores, bleeding gums), any respiratory illnesses, and/or any other known transmissible infectious diseases during subsequent study visits.
- Any changes to recorded health status from intake that would deem participant to be ineligible during subsequent study visits.
- Has Asthma
- Has claustrophobia
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are employees directly involved in the conduct of the study.
- Has a history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 12 months of Visit 1 as disclosed by participant during evaluation.
- Is a female who is breastfeeding or pregnant, as disclosed by the participant.
- Class III Obesity: Body Mass Index (BMI) ≥ 40 kg/m2
- Underweight: BMI < 18.5 kg/m2
- Resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg
- Resting heart rate <40 or ≥ 110 beats/min (for participants ≥60 years)
- Current tobacco/nicotine use
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center and BU Medical Campus
Boston, Massachusetts, 02118
About this study
Physical activity and its intensity level is a critical determinant of health. Digital Health Technologies, such as wearable accelerometers (wrist-worn watch-like devices), can provide researchers and clinicians with objective measures of activity intensity, duration, and effect on an individual's physiology which can provide important insight into overall health. The purpose of this observational study is to assess how well wrist-worn devices can measure the intensity of movement and exercise. This study is designed to rigorously validate existing activity classification algorithms using synchronized multi-sensor data and indirect calorimetry during structured, semi-structured, and free-living tasks.
Read the detailed description
The study involves three in person visits and a one week at home period with the first visit being an intake assessment of eligibility to participate in the study. If a participant consents to participate and meets inclusion/exclusion criteria, the participant will be scheduled for the follow on in clinic visits. The second visit is the first of two in-laboratory activity-based visits. Healthy participants will wear: 1) three wrist-worn watch-like devices, the ActiGraph CentrePoint Insight Watch (CPIW), the ActiGraph Long-range Energy Alternatives Planning system (LEAP), and the GENEActiv, to measure movement, 2) a portable indirect calorimeter, the COSMED K5 Wearable Metabolic System, to measure oxygen use, 3) a heart rate monitor, the Polar Beat H10, while performing a pre-determined set of physical activities and activities of daily living, which range in intensity from sedentary to vigorous. The pre-determined activities participants will complete during the first physical activity-based visit include treadmill walking and running, posture transitions (e.g., lying, sitting, standing), ambulatory tasks, and activities of daily living which include sweeping with a broom, vacuuming, washing dishes, writing, and folding laundry. Following the completion of the first physical activity in-clinic visit, participants will complete a one week at home period. During the at home portion of the study, participants will be asked to complete the same daily living tasks previously listed, keep a daily activity diary, and wear one wrist-worn watch-like device, the ActiGraph CPIW, on their non-dominant wrist. Upon completion of the one week at home period, participants will complete their third and final in-clinic visit, where the participants will repeat all of the same activities and monitoring of movement through wearing: 1) three wrist-worn watch-like devices, the ActiGraph CPIW, the ActiGraph LEAP, and the GENEActiv, to measure movement, 2) a portable indirect calorimeter, the COSMED K5 Wearable Metabolic System, to measure oxygen use, 3) a heart rate monitor, the Polar Beat H10, while performing a pre-determined set of physical activities and activities of daily living, which range in intensity from sedentary to vigorous.
- Conditions
- Physical Activity
- Keywords
- Wearable accelerometers, COSMED K5 device, Montoye, ActiGraph, SciKit Digital Health (SKDH)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity assessment in healthy adults | Healthy adults who can meet the eligibility criteria will comprise the study cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (PA) based on algorithms compared to indirect calorimetry
The performance of current physical activity algorithms (e.g. Staudenmayer, SKDH, Montoye) will be compared to indirect calorimetry applied on multiple test devices to estimate physical activity levels.
Measured: 5 days
Secondary outcomes (2)
Consistency of endpoints to assess physical activity
The consistency of endpoints derived by current PA algorithm (e.g. Staudenmayer, SKDH, Montoye) will be compared to one another on multiple wearable Digital health technologies (DHTs) devices.
Measured: 5 days
Reliability of PA algorithms
Test-retest reliability of PA algorithms applied on multiple test devices will be compared with indirect calorimetry.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start4 Dec 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Kevin C Thomas, PhD MBA, Principal investigator, CABUSM, Anatomy and Neurobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270185
- Sponsor's protocol ID
- H-46255
- Other IDs
- 99086845
- Acronym
- MOVE
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Outcomes With Validated Exercise
- ClinicalTrials.gov ID
- NCT07270185
- Acronym / sponsor ID
- MOVE / H-46255
- Conditions
- Physical Activity
- Keywords
- Wearable accelerometers, COSMED K5 device, Montoye, ActiGraph, SciKit Digital Health (SKDH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 8 Dec 2025 (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.
Physical activity and its intensity level is a critical determinant of health. Digital Health Technologies, such as wearable accelerometers (wrist-worn watch-like devices), can provide researchers and clinicians with objective measures of activity intensity, duration, and effect on an individual's physiology which can provide important insight into overall health. The purpose of this observational study is to assess how well wrist-worn devices can measure the intensity of movement and exercise. This study is designed to rigorously validate existing activity classification algorithms using synchronized multi-sensor data and indirect calorimetry during structured, semi-structured, and free-living tasks.
Detailed description
The study involves three in person visits and a one week at home period with the first visit being an intake assessment of eligibility to participate in the study. If a participant consents to participate and meets inclusion/exclusion criteria, the participant will be scheduled for the follow on in clinic visits. The second visit is the first of two in-laboratory activity-based visits. Healthy participants will wear: 1) three wrist-worn watch-like devices, the ActiGraph CentrePoint Insight Watch (CPIW), the ActiGraph Long-range Energy Alternatives Planning system (LEAP), and the GENEActiv, to measure movement, 2) a portable indirect calorimeter, the COSMED K5 Wearable Metabolic System, to measure oxygen use, 3) a heart rate monitor, the Polar Beat H10, while performing a pre-determined set of physical activities and activities of daily living, which range in intensity from sedentary to vigorous. The pre-determined activities participants will complete during the first physical activity-based visit include treadmill walking and running, posture transitions (e.g., lying, sitting, standing), ambulatory tasks, and activities of daily living which include sweeping with a broom, vacuuming, washing dishes, writing, and folding laundry. Following the completion of the first physical activity in-clinic visit, participants will complete a one week at home period. During the at home portion of the study, participants will be asked to complete the same daily living tasks previously listed, keep a daily activity diary, and wear one wrist-worn watch-like device, the ActiGraph CPIW, on their non-dominant wrist. Upon completion of the one week at home period, participants will complete their third and final in-clinic visit, where the participants will repeat all of the same activities and monitoring of movement through wearing: 1) three wrist-worn watch-like devices, the ActiGraph CPIW, the ActiGraph LEAP, and the GENEActiv, to measure movement, 2) a portable indirect calorimeter, the COSMED K5 Wearable Metabolic System, to measure oxygen use, 3) a heart rate monitor, the Polar Beat H10, while performing a pre-determined set of physical activities and activities of daily living, which range in intensity from sedentary to vigorous.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity assessment in healthy adults | – | –Healthy adults who can meet the eligibility criteria will comprise the study cohort. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will come from patients who receive care at Boston Medical Center or on the Boston University Medical Campus and who reply to posted flyers about the research study. It is anticipated that about 80 healthy interested individuals 18-89 years old (half 18-59 and half 60-89) will be enrolled and after attrition ultimately data from 54 will be analyzed for the sample.
Key inclusion criteria (6 listed)
- Participant is willing and able to comply with study instructions, study visits, and procedures including wearing a tight-fitting respiratory mask
- Able to ambulate independently, including walking/running on a treadmill without assistance.
- Demonstrates fluency in English
- Montreal Cognitive Assessment (MoCA) score of ≥26
- Score of 100 on the Barthel Index
Key exclusion criteria (18 listed)
- Participation in other digital device trials within 1 week or investigational drug trials within 5 half-lives of last dose.
- Allergy to polyurethane resin (strap/wristband component), silicone rubber, nickel and/or steel.
- Has any planned surgical, dental, or medical procedure that would overlap with study participation.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at intake that precludes participant's participation in study activities including any self-reported diagnosis of cardiovascular disease, metabolic disorder, chronic obstructive pulmonary disease, cerebral vascular accident/stroke, stage 2 hypertension, use of any medication which alters heart rate (HR) response (e.g., Beta blockers and calcium blockers), any history of myocardial infarction high-risk unstable angina, uncontrolled cardiac arrhythmias, active endocarditis, symptomatic severe aortic stenosis, decompensated symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, acute noncardiac disorder that my affect exercise performance/be worsened by exercise (e.g., infection, renal failure), acute myocarditis or pericarditis, left main coronary stenosis or its equivalent, moderate stenotic valvular heart disease, electrolyte abnormalities, tachyarrhythmia or bradyarrhythmia's, atrial fibrillation, high-degree Atrioventricular (AV) block, mobility/orthopedic limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity (PA) based on algorithms compared to indirect calorimetry
Time frame: 5 days
The performance of current physical activity algorithms (e.g. Staudenmayer, SKDH, Montoye) will be compared to indirect calorimetry applied on multiple test devices to estimate physical activity levels.
2 secondary outcomes
Consistency of endpoints to assess physical activity
Time frame: 5 days
Reliability of PA algorithms
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Kevin C Thomas, PhD MBA principal investigator
CABUSM, Anatomy and Neurobiology
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 Physical Activity, run by Boston University 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 6 inclusion and 18 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: finished, as of the sponsor's last update on 29 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (PA) based on algorithms compared to indirect calorimetry (time frame: 5 days). 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 29 Sep 2026.