Measuring Outcomes With Validated Exercise

NCT07270185 | Recruiting

• 2 other identifiers: H-4625599086845
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Physical Activity

Keywords

Wearable accelerometers; COSMED K5 device; Montoye; ActiGraph; SciKit Digital Health (SKDH)

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (2)

• Consistency of endpoints to assess physical activity

  5 days

• Reliability of PA algorithms

  5 days

Study Arms (1)

Physical activity assessment in healthy adults

Healthy adults who can meet the eligibility criteria will comprise the study cohort.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Pfizer: collaborator

Study Sites (1)

Boston Medical Center and BU Medical Campus

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kevin C Thomas, PhD MBA

  CABUSM, Anatomy and Neurobiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin C Thomas, PhD MBA

CONTACT

617-414-2335; kipthoma@bu.edu

Colleen Fetherston, BA

CONTACT

973-975-7915; collfeth@bu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)