Measuring Outcomes With Validated Exercise (MOVE)

December 5, 2025 updated by: Boston University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kevin C Thomas, PhD MBA
  • Phone Number: 617-414-2335
  • Email: kipthoma@bu.edu

Study Contact Backup

  • Name: Colleen Fetherston, BA
  • Phone Number: 973-975-7915
  • Email: collfeth@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center and BU Medical Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Physical activity assessment in healthy adults
Healthy adults who can meet the eligibility criteria will comprise the study cohort.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Consistency of endpoints to assess physical activity
Time Frame: 5 days
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.
5 days
Reliability of PA algorithms
Time Frame: 5 days
Test-retest reliability of PA algorithms applied on multiple test devices will be compared with indirect calorimetry.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin C Thomas, PhD MBA, CABUSM, Anatomy and Neurobiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-46255
  • 99086845 (Other Grant/Funding Number: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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