Validating wrist-worn devices to measure movement and exercise intensity

Measuring Outcomes With Validated Exercise

This study tests whether wrist-worn activity trackers accurately measure how hard and how long healthy adults exercise.

Quick facts

• Study type: Observational
• Enrollment: 54 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Boston University (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07270185 on ClinicalTrials.gov

What this trial studies

Healthy adult participants attend three in-person visits and complete a one-week at-home monitoring period while wearing multiple devices. In clinic, participants wear three wrist accelerometers (ActiGraph CPIW and LEAP, and GENEActiv), a portable indirect calorimeter (COSMED K5), and a Polar H10 heart rate monitor while performing treadmill walking/running, posture changes, ambulatory tasks, and common household activities. The study synchronizes multi-sensor data with indirect calorimetry across structured, semi-structured, and free-living tasks to validate existing activity-classification algorithms. Data from the one-week at-home period are used to test algorithm performance in real-world conditions.

Who should consider this trial

Good fit: Ideal participants are healthy adults who can walk/run on a treadmill, are fluent in English, have a MoCA score ≥26, a Barthel Index score of 100, reliable internet access, and no implanted electronic devices or relevant allergies.

Not a fit: People with implanted medical devices, significant medical conditions, cognitive impairment, inability to ambulate independently, or relevant material allergies would likely not benefit from participating.

Why it matters

Potential benefit: If successful, this could make wrist-worn trackers more accurate for measuring exercise intensity and duration, helping people and clinicians track activity and tailor recommendations.

How similar studies have performed: Previous validation studies combining wrist accelerometers and indirect calorimetry have shown reasonable accuracy for some activities but have limitations, so further rigorous validation is common and needed.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

• Boston Medical Center and BU Medical Campus — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Kevin C Thomas, PhD MBA — CABUSM, Anatomy and Neurobiology
• Study coordinator: Kevin C Thomas, PhD MBA

Conditions: Physical Activity, Wearable accelerometers, COSMED K5 device, Montoye, ActiGraph, SciKit Digital Health