BioTrainer™ Clinical Studies
Introduction
According to the Centers for Disease Control and Prevention (CDC), obesity in the United States is epidemic and predictions are that 40% of Americans, or 68 million people, will be obese by the year 2010 (presented at the North American Association for the Study of Obesity, Oct, 2003). In a recent poll commissioned by the Harvard School of Public Health, obesity surpassed smoking as a public health concern (NY Times, Oct. 12, 2003). According to the CDC (2003), in the last 10 years, obesity rates have increased by more than 60% among adults and since 1980, obesity rates have doubled among children and tripled among adolescents.Despite the proven benefits of physical activity, more than 60% of American
adults do not get enough physical activity to provide health benefits. This sedentary condition which few are addressing is “physical inactivity” and it’s seriously compromising our nation’s health.
As evidence is clear that physical inactivity is a contributing factor to the
growing epidemic of obesity, there is a pressing need for new
low-cost self-motivating tools to help both adults and children
become more aware of, and change behaviors to improve their overall
levels of exercise. New recording and assessment methods are needed
to provide a means of accurately quantifying more complex components
of physical activity and use this feedback to help motivate and
promote increases in daily exercise.
Measuring Physical Activity:
Increasing evidence points to the need to know more about the health benefits
of physical activity, and the effectiveness of activity interventions.
A major limiting factor in studying and monitoring physical activity
behaviors and the associated health benefits has been the lack
of a reliable, valid, and standardized assessment tool (Melanson & Freedson,
1996). Currently, there is no universally accepted “gold standard” method
for measuring physical activity (Melanson & Freedson, 1996). Assessing
physical activity is a complex and challenging issue. There are
a number of methods to assess physical activity and each has some
relative advantages and disadvantages (Tudor-Locke & Myers, 2001).
Self-report instruments are the most commonly used indicators
of physical activity. Direct observation techniques have been
commonly used to assess activity behavior. (McKenzie, et al, 2000,
Elder, et al, 1998, Rowe, et al, 1997, Sallis and McKenzie, 1991).
In most systems such as SOPLAY (McKenzie, et al, 2000) and SOFIT
(Rowe, et al, 1997) an observer codes the type, and intensity
of activity performed during a short periodic interval along with
other details about the behavior or setting. The detail available
through direct observation techniques offers some significant
advantages for understanding activity behavior, but the time and
cost of observations generally makes this type of assessment most
practical for research or instructional applications. It is often
used as a criterion measure to evaluate other methods.
The most effective tool for measuring physical exercise are various electronic
motion sensing devices that capture details about activity patterns
during normal daily life (Welk, Corbin, Dale, 2000). These instruments
overcome the limitations of self-report and direct observation
instruments and provide an objective indicator of physical activity.
A formidable task for the use of these motion sensing devices
is to provide an uncomplicated method of direct assessment and
achievement scoring and reward that is easy to understand and
administer.
A number of different electronic devices are available including heart rate
monitors, pedometers and accelerometer-based activity monitors
all of which have their own advantages and disadvantages. The
sections below will provide more detail on these devices and lead
to a justification for the measurement approach selected for the
BioTrainer activity monitor.
Heart Rate Monitors:
Heart rate monitors are popular in many physical exercise programs to teach
cardiovascular fitness and to track activity. These systems typically
consist of a chest belt and integrated transmitter which sends
a signal to a wrist-worn receiver. The wristwatch display usually
provides a flashing heart icon for each detected heart beat and
the rate is computed in beats-per-minute and displayed on a small
LCD readout. While heart rate monitors can deliver useful information
during specific exercise workouts they are not useful for tracking
physical activity patterns under the normal lifestyle activities
of daily living and rate can be influenced by nervousness, dehydration
and stress (Welk, Corbin, & Dale, 2000b). They are prone to interference
from other electrical equipment (and other monitors) and are inconvenient
for participants to wear.
The inventors past experience with heart rate monitors have shown these devices
to be seriously prone to frequent signal interruptions, radio
frequency interference, and transmission problems. These limitations
were experienced during extensive testing of the Polar OEM model
#PCBA receiver and transmitter for use in our fitness equipment.
When the transmitter belts were worn over extended periods of
time and during more vigorous activities such as running or jumping,
electrode contact became problematic and caused artifact-induced
signal dropouts and rate errors. We also found the easy touch
technology, where the finger is placed over a photo-sensor or
across sensing pads on a wrist unit, to be difficult to manage
requiring precise finger placement and little or no movement by
the user to obtain an accurate reading.
While heart rate monitors can provide a useful indicator during specific bouts
of exercise, they are not useful for tracking activity patterns
under normal activities of daily living (Welk, Corbin, & Dale,
2000b). Welk’s research also cited another major problem with
heart rate monitors is that the more physically active user may
actually have a lower heart rate than their more sedentary counterparts,
a variable, which could be confounding to the user. Further, heart
rate does not typically increase or decrease to a large degree
with normal life-style activities, although it does with more
strenuous activities. Thus the heart-rate monitor is not sensitive
enough to record the more subtle changes in physical activity
which is easily accomplished with accelerometers.
Pedometers:
For a number of years, the pedometer (also known as a stepometer or step-counter)
has been used successfully to motivate and assess physical activity
and increase walking behavior (Todor-Lock, C., 2002). Although
pedometers are very cost effective, one of the main flaws in using
pedometers however is that they do not record intensity or velocity
of movement nor do they have memory storage, restricting their
use to measures of total accumulated steps per day. Pedometers
are small step counting devices usually attached at the waist
that count and display the number of steps performed during walking
activity (Freedson and Miller, 2000). Some devices even contain
AM/FM radios, provide verbal feedback, play music and pace your
walking cadence. Pedometers can be found in almost any consumer
catalog or retail store. Some of the more popular manufactures
include Digi-Walker, Omron, Acumen, Bodytrend, Oregon Scientific,
Sportline, Freestyle, Brookstone, AccuStep and many others. These
clip-on devices are inexpensive, ranging from less than $15 up
to $75 (Tudor-Locke & Myers, 2001a). Because the pedometer is
relatively small and light weight (similar to the size of a pager),
it is not intrusive (Welk et al., 2000a&b). In addition, virtually
all segments of the population (including children, adults, and
people with disabilities) can wear pedometers (Vincent & Pangrazi,
2002). Pedometers give people immediate feedback about how many
steps they have taken during the day (Tudor-Locke, 2001b). This
feedback can increase personal confidence and may also increase
motivation to achieve a certain number of steps per day (Bassett,
2000). Moreover, a pedometer can be used as a coaching and self-monitoring
tool (Freedson & Miller, 2000) to help people set goals (Bassett, 2000). A pedometer can also
document change and recognize progress in daily activity levels
(Beighle, Pangrazi, & Vincent, 2001). As a result, the pedometer
has been a reasonably effective tool for helping people to increase
physical activity levels.
The popularity of pedometers has increased in recent years, due in part, to
the effective marketing and promotion of “10,000 step programs”.
A study conducted at the Department of Medicine, Wakayama Medical
College, Japan (Iwane, M., et al., 2000) investigated the effects
of walking 10,000 steps per day or more (measured using a pedometer)
on blood pressure and cardiac autonomic nerve activity in mild
essential hypertensive patients. The results indicated that walking
10,000 steps per day or more was effective in lowering blood pressure,
increasing exercise capacity, and reducing sympathetic activity
in hypertensive patients. The idea of using 10,000 steps as a
daily goal caught on quickly and a number of other step programs
were born. A current Google search for 10,000 step programs draws
495,000 hits. Step counting programs, were initially introduced
by companies that manufactured step-counting pedometers. The trend
quickly spread to weight-loss programs, walking clubs, schools,
state and local programs and to large national programs such as
Queensland Health, Health Partners, Shape Up America, America
on the Move and now the President’s Challenge Program has endorsed
the use of pedometers as a method to increase physical activity.
The American Diabetes Association also packages a step counter
with its new book on the benefits of physical activity (Small
Steps, Big Rewards) and McDonald's is offering a free counters
with its new Happy Meal for adults, which is now being sold throughout
their franchise.
While there are thousands of programs in place, there is no standardized model
for setting baselines, realistic goals or for evaluating these
programs. Most programs set their own guidelines and customize
their own action plans but little, if any, is known about their
effectiveness. There is also much confusion as to how many steps are optimal for age, weight, gender, body mass index and
lifestyles. According to Greg Welk, a physical-activity researcher at Iowa State University and formerly
with the Cooper Institute for Aerobics Research, "The number 10,000 has developed almost mythical proportions - it's actually not yet clear at what point you start getting a benefit" (Time, Oct. 13, 2003). Catrine Tudor-Locke, a health promotion expert at Arizona
State University East suggested that “a common target is to achieve 10,000 steps per day. However this is likely to
be too low a target for young people who could potentially achieve
12,000 to 16,000 but too high for the sedentary adult who may
only reach 3,000 – 5,000. For the sedentary, setting a target
of 10,000 steps presents a high-risk situation for failure and
attrition. Goals set should be an improvement from baseline, realistic,
achievable and sustainable over the long term” (Philadelphia Inquirer, Oct. 3, 2002). James Hill from the Center for Human
Nutrition at the University of Colorado also emphasizes the use
of a baseline approach and suggests that 2,000 steps above baseline
is a modest goal that will burn roughly 100 calories (Associated
Press, July 14, 2003).
Limitations of Pedometers:
Despite the appeal and popularity of pedometers, they also have many mechanical
and functional limitations. Most pedometers use a simple spring
suspended lever arm (sensor) that moves up and down and makes
contact with ambulation. An electrical circuit closes with each
step and the accumulated step count is displayed digitally on
a LCD screen. Some devices require the user to set the tension
or sensitivity of the sensor arm for accurate counting. Improper
adjustment will seriously affect the accuracy of the device (IM
Systems engineering evaluation) producing significant over-counts
or under-counts. The main problem however is that they do not measure the intensity (how hard), duration
(how long), or frequency (how often) physical activity occurs (Beighle, Pangrazi, & Vincent, 2001). In addition, pedometers generally underestimate
the number of steps taken during higher intensity activities (Rowlands,
Eston, & Ingledew, 1999) and show consistently more errors during
slow walking (Bassett et al., 1996). Discrepancies among different
models of pedometers can also limit their usefulness (Freedson & Miller,
2000). Furthermore, pedometers display steps taken over a period of time and are not
able to store or recall single-day values over a period of many days. Thus, daily written records
must be kept if the pedometer is reset daily. Pedometers are also not as accurate for people who do a fair amount of bending
and/or who have excessive abdominal fat, as the pedometer may
move away from the person’s body (Tudor-Locke & Myers, 2001b).
Additionally, pedometers cannot distinguish between walking and
running (Bassett, 2000) and cannot measure static movements, non-locomotor activities,
upper-body exercises and cycling (Beighle, Pangrazi, & Vincent,
2001).
Activity Monitors (BioTrainer product):
Recent studies and technological advances have shown that frequency, duration
and intensity of physical activity can be objectively measured by wearable acceleration-based activity
monitors, and these devices can accurately record body movements. Notwithstanding their higher cost, accelerometer measuring techniques have
been shown to provide a high level of accuracy for objectively
assessing physical activity (Fairweather, et al., 1999; Ott, et
al., Welk, et al., 1999, 2000b; Trost, et al., 2000; Nilsson,
et al., 2002; and Sallis, et al., 2002). A variety of commercially
available activity monitors are available to measure complex physical
activity patterns, display and store the data and some designs
provide download for PC analysis. These devices are usually small
and unobtrusive but differ from pedometers in that they can sample
and store detailed information about intensity levels, movements
and physical activity patterns (Kohl et al., 2000). Ranging in
price to well over $2,000, these monitors come in many forms and
are designed to perform a variety of functions but have been largely
used for research applications. For instance, IM Systems manufactures
5 commercial models: The “BioTrainer-II” for physical activity
and fitness (patent #5,749,372), the “BioTrainer-Pro” for sports
medicine and rehabilitation, the “ActiTrac” for sleep disorders
and behavioral assessment (FDA Cleared # K992410), the “PAM-RL” for
restless legs and period limb movements (FDA Cleared # K010997)
and the “DigiTrac” for Parkinson’s tremor and dyskinesias.
The main component of an accelerometer monitor is the sophisticated sensor assembly,
which is generally made of piezoelectric, piezoceramic or piezofilm
materials and can be broadly termed as either uniaxial or triaxial.
Uniaxial accelerometers measure accelerations in a single plane,
and can be attached to the trunk or limbs, whereas triaxial accelerometers
measure accelerations along three planes; vertical, anterior-posterior,
and medio-lateral (Freedson and Miller, 2000). The principal function of accelerometers is that the sensor converts physical movements into electrical signals that are proportional
to the muscular force producing motion (Melanson and Freedson, 1996). The signals are then sampled by an analog to
digital converter (usually 10 to 40 Hz.), and input to a microprocessor
for storage and consequent download for analysis. Some activity
meters also provide for a direct panel readout and/or graph of
activity measures on a LCD display such as IM Systems’ BioTrainer
model. Accelerometer monitors can store raw digitized movement
data directly into memory, or average the data for storage in
selected epochs of time (e.g. 2, 15, 30, 60 or 120 seconds). They
can also be used to estimate caloric burn and energy expenditure
(Welk, et al.,2000). The monitors are small, easy to use and well
suited to assessing physical activity in both children and adults.
In addition to these attributes, the overwhelming advantage of newer generation
accelerometers is that the embedded microprocessor can be custom
programmed to provide any number of direct display features and
functions for supporting simple or complex behavioral interventions
and protocols.
BioTrainer Activity Counts:
Physical activity recorded by an accelerometer-based activity monitor is derived
from the output of an accelerometer sensor using standard analog
to digital conversion (A/D) methods and digitally sampled at a
rate of 40 samples per second with a resolution of 10 bits or
1024 parts per sampled value. These values are then averaged by
means of digital integration and converted into activity counts
or for display on the LCD readout. This sensitivity range will
capture activity from subtle movements (about 0.05-0.2 g) to moderate
activity (about 0.2 to 1.0 g) to vigorous walking and jogging
(about 1.0-4.0 g). These sensitivity ranges are approximate for
varied populations and were determined by clinical investigations
(IM Systems) and through an NIH-SBIR grant #5R44MH52049 awarded
to IM Systems which evaluated the movement and acceleration characteristics
of participants in a treadmill/weight loss study described below
(APA, 1998). Validated formulations for quantifying average body
acceleration, developed for IM Systems’ BioTrainer activity monitors,
are programmed into the monitor’s firmware and processed in real-time
for direct display of Activity Counts. This conversion (a derivative
of the method described in IM Systems’ U.S. Patent # 5,749,372)
uses the formula where 1.0 “g” of motion (referenced to earth
gravitation) equals 9.807 m/sec2. The equation gave = 3.071 x [Activity Count / time period (seconds)] are used to convert acceleration
of body motions into activity points. The constant of 3.071 is derived as follows:
the Actometer will be computer calibrated to accumulate an activity
count of 1.0 for a period of 32.2 seconds when placed on a moving
sinusoidal calibration table set to 0.3 g peak-to-peak at a rate
of 4 hertz. The activity rate is therefore equal to 1.0 / 32.2
seconds which equal 0.03106 activity units/second. Average acceleration
is = 0.3 g’s p-p x (0.636 / 2) = 0.0954 gave. Therefore: gave/activity rate = 0.0954 / 0.03106 = 3.071. To increase the resolution or adjust
the activity count scale, the constant can be divided by a fixed
value (e.g. 3.017/20 will increase the Activity Counts by a factor
of 20).
Also, a recent study (Welk, Almeida, Morss, 2003) supported the validity of
the BioTrainer acceleration technology (programmed with above
algorithm) for assessing physical activity.
BioTrainer Calorie Burn Counter:
The BioTrainer measures horizontal and vertical body acceleration. When positioned
(clipped) to the front part of a person’s waist, this acceleration
is correlated to exercise calories during walking, jogging or
running activities. Additionally, the BioTrainer adjusts exercise
calories accumulated in proportion to a person’s body weight selected.
The BioTrainer correlation technique is based on the fourth edition of Exercise Physiology, Energy, Nutrition, and Human Performance [1]. Table 10.1 of this publication gives predictions of energy expenditure
versus walking speed and body weight. From the values of Table
10.1, treadmill walking tests at IM Systems and the VO2 oxygen
uptake studies performed at the Cooper Institute of Aerobics Research,
the following equation was derived that approximates exercise
calories versus velocity and body weight.
Equation 1. C = (.00719W + .32564) V
C = calories per minute
W = body weight (lbs)
V = walking, jogging, running velocity (mph)
The BioTrainer measures the average body horizontal and vertical acceleration
when clipped to the front part of a person’s waist. This acceleration
is directly proportional to body velocity as indicated by the
following equation.
Equation 2. A = K ˜ V
A = average positive acceleration per minute
K = BioTrainer scale factor
V = body velocity (mph)
From equation 2, V = A / K
Substituting for V in equation 1 yields,
Equation 3. C = (.00719W + .32564) ˜ A / K
This equation is used in the BioTrainer monitor to correlate body acceleration
and body weight to exercise calories expended.
Activity Count Study:
In a weight loss study (publish in JAMA by Anderson, R., et al, 1999), the BioTrainer-Pro
monitor, programmed to display activity points, was given to 20
overweight female subjects instructed to increase their lifestyle
activities by wearing the monitor with visual feedback. A second
group of 20 overweight female subjects attended 3 aerobic classes
per week. After 16 weeks, the study showed that increased casual
lifestyle activity was just as effective as exercise classes for
weight loss and both groups lost about 17.5 pounds. But after
12 months, the group using the BioTrainer gained only 0.5 pounds
while the aerobics group regained 3.5 pounds. This study demonstrated both that increased
lifestyle activity may be as effective as structured exercise
classes and that visual activity feedback counts was motivational
and helped reduce the “yo-yo” effect during weight-loss maintenance.
(Research was supported by National Research Service Award #DK09241
and the National Institutes of Health - NIH #MH0070).
Activity Count Calibration and Test:
Piezoelectric accelerometer technology is well developed at IM Systems and used
in most all of the company’s ambulatory activity monitors. Existing
methods of absolute g-force calibration including a variable acceleration
table is use to set range and sensitivity of the movement detection
circuits. Bench testing and calibration is performed at IM Systems’ development
laboratory on each monitor to comply with established standards.
The analog and data measurements must all match within acceptable
tolerance of no more than ± 0.5% @ 3Hz. Tolerance for acceleration
frequencies above or below 3Hz but must fall within ±1.0% for
the full specified bandwidth of the monitor (0.1 to 12 Hz.).
The BioTrainer is currently tested and calibrated using the same set-up and
methods as for our BioTrainer monitors. Calibration and test is
accomplished by placing the monitor on a moving platform fixture
that oscillates up and down in the vertical axis. The calibration
consists of a long throw 15" speaker with cone modified to accept
an oscillating platform table. A low frequency signal adjustable
from 0.1 Hz to 12 Hz will drive the platform with a sinusoidal
motion. Exact calibration is achieved by also mounting on the
test platform a precision accelerometer (IC Sensor type 3145)
as the standard with its signal output directed to a lab PC programmed
with calibration software written in Visual Basic-6. Acceleration
sensitivity is adjusted through an automated method that inserts
a calibration factor into the ROM memory of the Actometer’s microprocessor
to bring each unit to within the specified range. This software
calibration method therefore automatically compensates for the
accelerometer sensors or amplifiers that are naturally outside
the prescribed tolerances. An automatic calibration procedure
for high production is now being considered. If no calibration procedures are employed, variations of about 15% max are typical.
This is well within the accuracy limit for a consumer product.
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