Actively Recruiting
Measuring Outcomes With Validated Exercise
Led by Boston University · Updated on 2025-12-12
54
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Measuring Outcomes With Validated Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow study instructions, visits, and wear a tight-fitting respiratory mask
- Able to walk and run on a treadmill independently
- Fluent in English
- Montreal Cognitive Assessment (MoCA) score of 26 or higher
- Score of 100 on the Barthel Index
- Reliable internet access
You will not qualify if you...
- Participating in other digital device trials within 1 week or drug trials within 5 half-lives of last dose
- Allergy to polyurethane resin, silicone rubber, nickel, or steel
- Planned surgical, dental, or medical procedures overlapping study period
- Having cardiac pacemakers, electronic pumps, or implanted medical devices
- Significant medical conditions that prevent study participation, including cardiovascular disease, metabolic disorders, respiratory illnesses, stroke, severe hypertension, certain heart conditions, or mobility limitations
- Skin conditions or wounds on wrists interfering with wearable sensors
- Tuberculosis, oral lesions, respiratory illnesses, or other infectious diseases during visits
- Changes in health status making participation unsafe
- Asthma or claustrophobia
- Study staff involved in conduct of study or their family members
- History of heavy alcohol use exceeding 7 drinks/week for females or 14 drinks/week for males in past 12 months
- Female who is pregnant or breastfeeding
- Class III obesity (BMI ≥ 40 kg/m2) or underweight (BMI < 18.5 kg/m2)
- Resting blood pressure ≥ 160/100 mmHg
- Resting heart rate less than 40 or greater than or equal to 110 beats/min for participants 60 years or older
- Current tobacco or nicotine use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Medical Center and BU Medical Campus
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
K
Kevin C Thomas, PhD MBA
CONTACT
C
Colleen Fetherston, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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