ActiGraph 02 Wireless Activity Monitor User Manual 1

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Objective Physical Activity and
Sleep/Wake Monitoring Solutions
Health research
Clinical trials
Epidemiological studies
Chronic disease management
Sleep research
Clinical sleep medicine
Corporate wellness
Sports medicine
actigraphcorp.com
Innovative objective monitoring solutions
ActiGraph is a leading provider of objective physical activity and sleep/wake monitoring
solutions for the global research community. Our innovative and extensively validated
accelerometry hardware and software system delivers accurate, measurable insight into
the real world physiological behaviors of subjects involved in a variety of research and
clinical projects.
Validated technology delivers data you can trust
ActiGraph is widely regarded as the “Gold Standard” in objective ambulatory measurement
technology. Backed by more than a decade of independent scientific validation, ActiGraph
solutions have been used in hundreds of complex, large scale, multi-site research studies
around the world to capture and deliver accurate and reliable objective physical activity
and sleep/wake data. Our trusted measurement technology is supported by a variety of
advance wireless mobile and cloud communication tools to increase project flexibility and
accommodate a wide range of study designs and protocol requirements.
Customizable solutions, seamless implementation
ActiGraph hardware devices are supported by an adaptable suite of technology solutions
designed to meet the specific needs and complexities of your project. Our powerful ActiLife
software, suite of mobile apps, Study Admin web portal, and API can be custom configured
to achieve your data collection objectives while streamlining workflow and helping to ensure
that studies are completed on time and on budget.
ActiGraph monitoring solutions can be easily implemented within your research project or
clinical trial to deliver high quality objective physiological measures, thereby improving the
integrity of your study data and eliminating issues associated with subjective data collection
methods and unreliable measurement tools.
Health Research
Solutions
The ‘Gold Standard’ in physical activity measurement
Optimize trial data quality, safety and cost effectiveness
ActiGraph’s ambulatory monitoring devices have been used for
more than a decade in thousands of human research projects
and hundreds of large scale population studies involving physical
activity, energy expenditure and their relationships to chronic health
conditions such as obesity, diabetes, cardiovascular disease, cancer,
and sleep disorders.
Objective information about real world patient behavior is a valuable
resource to researchers and physicians involved in phase I-IV clinical
trials. Endpoints related to subjects’ daily activity and sleep behaviors
provide vital, measurable insight into the therapeutic value of an
investigational treatment and may help identify possible adverse
events during intervention.
Advantages
Advantages
Most scientifically validated objective activity monitoring
technology available.
Powerful research-driven software platform delivers advanced,
highly customizable metrics.
Innovative mobile and web-based tools accommodate a broad
range of study designs and interventional protocols.
Widespread global implementation guarantees data comparability
with thousands of published studies.
Clinical Trial
Solutions
Continuous objective physiological measures augment patient
reported outcome data to increase contextual meaning and
enhance overall data quality.
Real time remote data reporting improves participant care,
safety and compliance monitoring.
Two-way site to subject messaging enhances interaction
between the research team and study participants.
Sleep Assessment
Solutions
Wellness
Solutions
Reliable in-home sleep/wake measurement
Motivating healthy lifestyle choices
ActiGraph delivers objective information about a patient’s real world
sleep behavior and rest-activity rhythms, helping physicians make
appropriate diagnostic and treatment decisions and providing
measurable endpoints to research professionals investigating a
wide range of influential factors.
Implementation of objective physical activity monitoring within a
corporate wellness or health promotion program is a powerful
way to engage and motivate participants to adopt healthier
behaviors, while delivering measurable results on participation
and outcomes.
Advantages
Advantages
In-home actigraphy monitoring provides a validated, minimally
invasive, and cost-effective alternative to lab based sleep studies
Obtain measurable insight on participant behaviors, health
status, and wellness program adherence and success.
Capture objective 24 hour data with one simple device to obtain
valuable insight into the relationship between daytime activity
and sleep/wake behavior.
Foster participant engagement through real-time mobile
feedback and access to an interactive web portal, resulting in
long term program adherence and improved health outcomes.
Advanced software platform delivers highly customizable sleep/
wake analytics, robust clinical data reporting options and a variety of
mobile and web-based tools to streamline project workflow.
Real-time remote data reporting allows program administrators
to monitor participants and implement personalized coaching as
needed.
Integrated Monitoring Solutions
At ActiGraph, we understand that a one size fits all approach to objective patient monitoring fails to take into account the diverse needs of each project based
protocol, endpoints, subject populations, and other factors. Our innovative hardware and software solutions platform offers a complete suite of integrated
mobile and web-based tools that can be configured to achieve the unique communication, reporting and analysis requirements of your study.
Secure Cloud
Admin
Portal
Subject/Patient
Portal
ActiLife
Subject/Patient
Environment
Research
Environment
Mobile Apps
API
ActiGraph
Monitors
Hardware Solutions
Backed by more than a decade of independent scientific validation, ActiGraph physical activity and sleep/wake monitors are the most accurate and widely
used devices of their kind. Our newest Bluetooth® Smart wireless monitoring devices combine ActiGraph’s trusted measurement technology with a host of
innovative features and real-time communication options to unlock the potential of your research or clinical project.
Setting the Standard for 24 Hour Monitoring
ActiGraph’s all new wGT3X-BT and wActiSleep-BT monitors, in conjunction with our
innovative software platform, deliver objective 24 hour physical activity and sleep/wake
measurements including:
Raw acceleration
Energy expenditure
MET rates
Steps taken
Physical activity intensity
Heart rate R-R intervals*
Body position
Ambient light
Sleep latency
Total sleep time
Wake after sleep onset
Sleep efficiency
®
Specifications
wGT3X-BT
Dimensions
Weight
19 grams
Sample rate
ActiGraph Device Features
Wireless Communication with ActiLife
Initialize devices, view summary data and operating status and stream live data
wirelessly using the ActiLife analysis software.
Dynamic range
Battery life
Data storage
Communication
Water resistance
Wear location
Warranty
Mobile App Support
ActiGraph’s suite of mobile apps allows you to communicate with active
devices in the field while providing subjects with real-time feedback and the
opportunity to interact with members of your study team.
wActiSleep-BT
4.6 x 3.3 x 1.5 cm
30-100 Hertz
+/- 8G
31 days †
120 days/2 GB
USB, Bluetooth LE
1 meter, 30 min.
Wrist, waist, ankle, thigh
1 year
Data Analysis Features
Wear time compliance
Daytime activity
Basic sleep scoring
Inclinometer graphing
Capacitive Touch Sensor
An integrated capacitive touch sensor on the back of the device senses whether
the device is on or off, allowing for foolproof wear time detection.
Proximity Detection
Detect and log other devices within range, providing valuable information about
social interaction among subjects. Stationary devices can be placed throughout
the subject environment to monitor behavior in various predetermined locations.
* Requires compatible wireless heart rate monitor
† Wireless disabled, 30 Hz sample rate
Bed time auto detection
Advanced PLM scoring
Actogram data chart
Clinical data report
Data Vault access
The wGT3X-BT is an FDA cleared Class II medical device within the United States and a Class I medical device
within the European Union that abides by the regulatory requirements listed below:
ActiGraph is compliant with IEC standards for “Type BF Applied Part”
EN60601-1-Medical Device General Safety Requirements
Part 15.109 (US) – Radiated Emission Limits of Unintentional Radiators
Part 15.249 (US) – Radiated Emission Limits of Intentional Radiators
All ActiGraph products are manufactured Lead Free and
are RoHS Compliant
ICES-003 (Canada) – Interference Causing Equipment Standards for
a Digital Apparatus.
The wGT3X-BT is water resistant in accordance with IEC 60529
IPX7, or immersion in one (1) meter of water for up to 30 minutes.
Software Solutions
The ActiLife desktop software is ActiGraph’s premier actigraphy data analysis and management platform. Trusted by researchers and healthcare providers
around the world, ActiLife is used to prepare ActiGraph devices for data collection and to process, score and securely manage study data. ActiLife’s extensive
selection of customizable analysis and management tools streamline workflow and deliver accurate, reliable data reports with ease.
Data Processing & Analysis
ActiLife’s robust screening and analysis toolkit allows users to process and
score collected data using a comprehensive selection of independently
developed and validated algorithms. Batch processing features allow users
to score multiple datasets simultaneously and export them into a single
consolidated CSV or Excel® report.
Wear time validation screening
Cut point and MVPA analysis
Activity bout detection
Energy expenditure
(kcals and METs)
Sedentary analysis
Sleep scoring
GPS file correlation
Periodic limb movement
(PLM) analysis*
ActiLife Data Vault
Raw Data Analytics
ActiLife’s integrated Data Vault is a centralized cloud based
repository that provides secure data storage and archiving and
enables users to seamlessly share data across multiple sites. The
ActiLife Data Vault reduces local system requirements and IT
workload associated with onsite storage and management of large
amounts of raw study data.
ActiLife provides tools which allow users to quickly view and extract
portions of large, high resolution raw datasets. The ActiLife Feature
Extraction tool provides a platform for extracting time and frequency
domain feature sets directly from the raw data files, which can be analyzed
further using statistical analytic platforms as a method for developing
application specific learning or pattern recognition algorithms.
* wActiSleep-BT devices only
Study Web Admin Portal
ActiLife Mobile Apps
ActiGraph’s suite of mobile apps enhance project flexibility and support
interventional protocols by giving researchers and study participants the ability to
interact with active wireless devices and view objective measures in real time during
data collection.
Mobile for Researchers
ActiLife Mobile for iPhone and iPad supports in-field device initialization and
allows research team members to view real-time summary data and operating
status reports.
Mobile for Study Participants
A subject-facing app gives participants the ability to monitor their health data,
enter subjective reports and interact with the study team from the convenience of
a mobile device.
ActiLife API
An available Application Programming Interface (API)
allows users to develop their own custom applications to
automate device deployments and downloads by enabling
programmatic control of ActiLife over a standard socket.
The ActiLife API is designed to run within closed systems,
ensuring regulatory compliance is not compromised
during clinical trial data collection.
ActiGraph’s web-based Study Admin Portal combines
the power of ActiLife with the simplicity and convenience
of cloud computing to deliver a turnkey activity
monitoring solution for clinical trials and structured
case studies. The Study Admin Portal provides many of
the same validated outcomes available in the ActiLife
software in an easy-to-use, automated system, allowing
your research team to monitor study progress and view
objective physical activity measures in near real-time
while offering the broad administrative support required
to manage multiple complex studies simultaneously.
Manage device inventory and deployment from
multiple sites with ease.
Perform seamless data collection – simply connect
the monitor and the system walks you through
setup and data uploads.
Monitor compliance, subject data, study progress,
and view analytical data reports in near real-time.
Collect data from the patient’s own smart phone or
home (requires Internet-enabled PC).
Please contact the ActiGraph Sales Team for more
information and pricing.
Representative Research Studies
ActiGraph monitoring solutions have been used extensively in many high profile research studies to objectively determine the physical activity profiles and
sleep behavior in hundreds of thousands of research subjects around the world. We have more than a decade of proven expertise in building scalable solutions
to meet the specific data collection, analysis, reporting and management requirements for projects of varying size and scope.
National Health and Nutrition Examination
Survey (NHANES)
The National Health and Nutrition Examination Survey (NHANES) is an ongoing
program of studies conducted by the National Center for Health Statistics
responsible for producing vital health statistics for the United States. ActiGraph
devices were used to collect physical activity data on 15,000 subjects in the 20032004 and 2005-2006 cycles of the survey. The most recent 2011-2012 cycle was
the first to monitor participants for 24 hours a day, resulting in one of the largest
samples of sleep data ever collected.
The Environmental Determinants of Diabetes in
the Young Study (TEDDY)
The aim of the TEDDY study is to identify the causes of type 1 diabetes mellitus
through the investigation of environmental and genetic triggers that cause high
risk children to develop diabetes. A consortium of six Clinical Centers throughout
the U.S. and Europe has been created to develop and carry out studies on a
proposed sample of 7800 neonates with a predetermined type 1 diabetes risk.
PROactive COPD Project
PROactive is a European project aiming to develop new tools that will enable
patients, doctors and researchers to accurately assess the improvement or
deterioration of Chronic Obstructive Pulmonary Disease (COPD). After an intensive
selection process, ActiGraph devices are being used to obtain a comprehensive
physical activity overview in 250 COPD patients enrolled in the study.
10
Women’s Health study
This landmark study conducted by Brigham and Women’s Hospital and Harvard
Medical School began in 1993 as randomized trial of low-dose aspirin and vitamin E
supplementation for cardiovascular disease and cancer prevention in nearly 40,000
female health professionals aged 45 and older. The trial concluded in 2004, and the
WHS has now evolved into one of the largest and longest-running observational
studies of women’s health in the U.S. An ancillary study examining physical activity
and health outcomes is currently underway involving approximately 30,000 women
from the original trial. ActiGraph GT3X+ devices are being used to objectively
measure physical activity for 7 days in study participants.
International Study of Childhood Obesity,
Lifestyle and the Environment (ISCOLE)
This collaborative study between Pennington Biomedical Research Center and the
Coca-Cola Company examines the influence of behavioral, physical, social, and policy
environments on weight gain in school aged children. ActiGraph GT3X+ devices are
used to collect objective 24 hour activity and sleep/wake data on 6000 children in 12
countries across North America, Latin America, Europe, Eurasia, Africa and the Pacific.
Transdisciplinary Research on Energetics and
Cancer (TREC)
Established by the National Cancer Institute (NCI) in 2005, the Transdisciplinary Research
on Energetics and Cancer (TREC) initiative is a major scientific research effort aimed at
reducing cancer linked with obesity, poor diet, and low levels of physical activity. ActiGraph
devices are used extensively to capture objective information about physical activity and
sleep behavior in adults and children in numerous studies under the TREC initiative.
Scientific Advisory Board
Established in January of 2011, the ActiGraph Scientific Advisory Board is composed of world renowned researchers and scientists from a range of disciplines,
including metabolic research, exercise physiology and behavioral medicine. The ActiGraph Scientific Advisory Board’s primary objective is to provide the company
with guidance and expertise as it continues to enhance its current hardware and software offerings and explores emerging applications for ActiGraph products.
David R. Bassett, PhD
Patty Freedson, PhD
David Bassett is a professor in the Department of Kinesiology, Recreation, &
Sport Studies at the University of Tennessee, Knoxville. His primary research
interest is in the objective measurement of physical activity and energy
expenditure in humans. He and his colleagues have studied the validity and
reliability of accelerometers, pedometers, and heart rate monitors, and they
have developed new methods of assessing physical activity. Dr. Bassett has
explored relationships between physical activity and body weight, blood
pressure, and other cardiovascular risk factors. He collaborates with researchers
in the fields of public health and transportation planning to study the
relationships between active transportation and health. Dr. Bassett is a fellow in
the American College of Sports Medicine, a member of the National Academy
of Kinesiology, and he serves on the editorial boards of Journal of Applied
Physiology, Journal of Physical Activity and Public Health, and Research Digest.
Dr. Freedson joined the faculty of the University of Massachusetts
Amherst in 1981, where she has taught courses in Human Physiology,
Exercise Physiology, Pediatric Exercise Physiology, Physical Activity and
Health. Dr. Freedson’s primary research focus is on the assessment of
physical activity using wearable monitors, a field in which she is an
internationally recognized authority. Dr. Freedson has published over
95 papers and is a former president of the New England Chapter of
the American College of Sports Medicine and former vice-president
of American College of Sports Medicine, as well as a fellow of the
Research Consortium, American College of Sports Medicine, and the
National Academy of Kinesiology.
Victor KR Matsudo, MD, PhD
Jorge Mota, PhD
Dr. Matsudo is the Scientific Director and Past-President of the Physical Fitness
Research Center of São Caetano do Sul (CELAFISCS) and a full Professor of
Medicine at Gama Filho University. He is the founder of the Agita Mundo
Network, an international organization dedicated to the promotion of physical
activity, and the Chairman of the Agita São Paulo Program, organized by the
State Secretariat of Health of São Paulo State. He is a founding member and
Chairman of the Physical Activity Network of the Americas (RAFA/PANA) and a
founding member of the International Society of Physical Activity and Health
(ISPAH). Dr. Matsudo has authored two books, 8 book chapters and numerous
research publications in the fields of physical activity and sports science.
Dr. Mota is Director of Research Centre in Physical Activity, Health and Leisure
at the University of Porto and Faculty’s President of General Assembly.
A visiting Professor at several Brazilian institutions, Dr. Mota is adviser for
the National Program for the Promotion of Physical Activity (MEXA-SE)
and is involved in physical activity promotion networks including HEPA
Europe and IPEN. His primary area of work is in issues relating to physical
activity, its health related effects, and specifically its relationship with noncommunicable diseases. Dr. Mota is also involved in the development and
implementation of programmes related to physical activity and health
promotion, and he has authored numerous peer reviewed publications.
Bonnie Spring, PhD
Stewart G. Trost, PhD
Dr. Spring’s research program on changing unhealthy lifestyle behaviors
has been funded continuously since 1976 by grants from the National
Institutes of Health, the American Heart and American Cancer Societies,
and the Department of Veterans Affairs. Dr. Spring is a Past President of the
Society of Behavioral Medicine (SBM), an elected Fellow of the American
Psychological Association, the American Psychological Society, and the
Academy of Behavioral Medicine Research, and she holds the American
Board of Professional Psychology’s Diplomate in Clinical Health Psychology.
Dr. Spring founded and Chairs the NIH-sponsored multidisciplinary Council
for Training in Evidence-Based Behavioral Practice, and she is founding editor
of the journal, Translational Behavioral Medicine: Practice, Policy, Research.
Dr. Trost is an internationally recognized expert in the field of physical
activity and obesity prevention in children. He has published 95 primary
research papers and 8 book chapters and has served as a consultant on
matters related to physical activity measurement and obesity prevention
to organizations including the National Institutes of Health, the United
States Centers for Disease Control and Prevention, the Robert Wood
Johnson Foundation, and the Australian Federal Government. Dr. Trost
headed the scientific committee responsible for drafting children’s physical
activity recommendations for Australian youth and was a member of the
CDC panel to establish evidence-based guidelines for physical activity in
school aged youth in the United States.
11
Our Mission
ActiGraph’s mission is to improve world health by providing the most
accurate and scientifically validated activity and sleep monitoring
hardware and software solutions to leading research, pharmaceutical,
healthcare and wellness organizations. ActiGraph is committed to
innovation, accuracy and first-class customer service.
actigraphcorp.com
49 East Chase Street. Pensacola, FL 32502
sales@actigraphcorp.com | 850.332.7900
©2013 ActiGraph

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