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| ID | Type | Description | Link |
|---|---|---|---|
| 99086845 | Other Grant/Funding Number | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity assessment in healthy adults | Healthy adults who can meet the eligibility criteria will comprise the study cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
| Reliability of PA algorithms |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin C Thomas, PhD MBA | Contact | 617-414-2335 | kipthoma@bu.edu | |
| Colleen Fetherston, BA | Contact | 973-975-7915 | collfeth@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin C Thomas, PhD MBA | CABUSM, Anatomy and Neurobiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center and BU Medical Campus | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Test-retest reliability of PA algorithms applied on multiple test devices will be compared with indirect calorimetry. |
| 5 days |