Wearable Technology
Ambulatory Monitoring
of Cumulative
Free-Living Activity
©EYEWIRE Potential Clinical Applications of Monitoring Patients
with Chronic Obstructive Pulmonary Disease
MARILYN L. MOY,
STEVEN J. MENTZER,
AND JOHN J. REILLY
C
hronic obstructive pulmonary disease (COPD) is
a major public health problem. COPD is currently
the fourth leading cause of death in the world [1],
and it is projected to rank fifth in 2020 as a world-
wide burden of disease [2]. COPD is the fourth leading cause
of chronic morbidity and mortality in the United States [3].
Disability, hospitalizations, and medication costs associated
with this disease account for US$15 billion in lost revenues
and healthcare expenditures annually, an estimated 16% of
the national healthcare budget [4]. The number of patients
with COPD has continued to increase as cigarette smoking,
the primary cause of this disorder, remains common in Amer-
ica despite aggressive public health initiatives to reduce to-
bacco consumption. It is thus anticipated that COPD will
remain a major public health problem well into the new mil-
lennium. Pathological changes are found in the central and pe-
ripheral airways, lung parenchyma, and pulmonary
vasculature. Clinically, patients with COPD experience stable
periods punctuated by exacerbations. With decreasing lung
function and exercise capacity, patients are at increased risk
for requiring supplemental oxygen therapy, hospitalizations,
and death. Research has focused on the development of novel
therapies for the treatment of COPD, but progress has been
slow. Therefore, improving the effectiveness of existing medi-
cal and surgical treatment modalities is crucial to the care of
these patients. In addition, the Global Initiative for Chronic
Obstructive Lung Disease executive summary report states
“while spirometry is recommended to assess and monitor
COPD, other measures need to be developed and evaluated in
clinical practice [5].”
Exercise Capacity and COPD
Exercise intolerance is a characteristic manifestation of
COPD. Patients with moderate to severe COPD are limited in
their abilities to perform work activities, recreational exercise,
and hobbies. When tested in the laboratory setting, patients
with COPD typically have a higher metabolic cost of exercise
with early-onset lactic acidosis and reduced maximal work
rate and oxygen consumption [6]. In the presence of advanced
disease, patients experience increasing difficulty in perform-
ing activities of daily living such as self-care and household
maintenance. The resultant inactivity leads to progressive
deconditioning that further increases the sense of respiratory
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effort related to any task. Physical inactivity is an important
variable in the dyspnea-inactivity-deconditioning spiral com-
monly seen. As exercise intolerance worsens over time, pa-
tients often become progressively homebound and isolated
from colleagues, friends, and family members. This sequence
of events frequently impairs the patient’s health-related qual-
ity of life (HRQL) [7], [8]. Concomitantly, some individuals
develop worsening depression and anxiety and may withdraw
progressively from their usual routines.
Patients with COPD demonstrate widely variable exercise
capacities even when they have identical degrees of airflow ob-
struction by pulmonary function tests [9]. Exercise capacity re-
flects lung function, cardiac output, peripheral muscle function,
nutritional status, neurological perception of breathlessness,
and psychological variables such as depression, outlook, and
level of self-esteem [10], [11]. Physical exercise is a crucial
component to the medical treatment of COPD to prevent
deconditioning, to improve HRQL, and to optimize response to
potential surgical interventions. Improved exercise capacity is a
major goal in the treatment of patients with COPD
Exercise training has been used in the treatment of COPD
since the early 1960s [12], [13]. Exercise training has been
shown conclusively to improve the exercise tolerance of pa-
tients with COPD [14], [15]. Exercise training increases max-
imal exercise tolerance and peak oxygen uptake in patients
with COPD while reducing muscle fatigue [16]. It improves
symptoms of breathlessness, leg fatigue, and HRQL. Opti-
mally, exercise training for patients with COPD should be
pursued initially in the setting of a formal pulmonary rehabili-
tation program. It is hoped that the techniques and strategies
learned in pulmonary rehabilitation will then be transferred
into and continued within the home environment for mainte-
nance of the achieved benefits over the long term. Because ex-
ercise limitation usually begins with impairment in
ambulation, exercise training in COPD has focused on train-
ing of the muscles of the lower extremities, alone or in combi-
nation with training of the arms or respiratory muscles. Lower
extremity training improves the exercise tolerance of patients
with COPD [12]. Duration of treatment has ranged between 3
and 18 months, with exercise sessions two to five times per
week. The training modalities have consisted of treadmill or
free walking, cycle ergometry, stair climbing, or a combina-
tion of these. Increases of up to 80 meters (10%-25% in-
0739-5175/03/$17.00©2003IEEE MAY/JUNE 2003 89
 Accurate measurement of exercise
capacity is important in assessing
the patient with chronic
obstructive pulmonary disease.
crease) in walking distance, 10 minutes in treadmill
endurance, and 5 minutes in cycle ergometry time (approx
70% increase) at submaximal workloads and up to 36% in-
crease in maximal workload have been reported following six
to 12 weeks of lower extremity training [6].
Current Assessments of Exercise Capacity
Standard pulmonary function testing provides information
on functional lung capacity at rest but provides limited infor-
mation on ventilatory requirements or functional perfor-
mance during exercise. It is often necessary to quantify the
degree of exercise intolerance experienced by the patient
with COPD. Measurement of exercise intolerance can assist
with diagnosis of symptoms, enable the assessment of the
functional impact of disease progression over time, and
identify responses to treatment interventions such as pulmo-
nary rehabilitation or medication.
The progressive incremental cardiopulmonary exercise
test provides the most comprehensive and objective assess-
ment of functional impairment and is extremely useful in
identifying the mechanism of exercise intolerance [17], [18].
Because it is an integrated test of cardiac and pulmonary re-
sponses to exercise, it is currently viewed as the gold standard
in diagnosing the cause of breathlessness. Performed either on
a treadmill or stationary bicycle, cardiopulmonary exercise
testing yields integrative information about the metabolic,
cardiovascular, and ventilatory processes that occur during
exercise and exercise effort. Systemic responses are measured
including work rate, oxygen consumption (submaximal and
peak) and carbon dioxide production, oxygen saturation, heart
rate and blood pressure response to exercise, and exercise
electrocardiogram [17]. Subjects are expected to exercise to
symptom limitation, reaching anaerobic threshold or maxi-
mum predicted heart rate. Subjects with severe COPD rarely
achieve anaerobic threshold and are limited by a pulmonary
mechanical limitation. In addition, patients frequently com-
plain of the discomfort of the head gear worn and the mouth-
piece that must be kept in the mouth, as well as the discomfort
of the seat on the stationary bicycle—all aspects of the test
that do not accurately mimic exercise in the home environ-
ment and may limit the maximum amount of exercise
achieved in the laboratory setting.
Timed walking tests can be used to measure exercise ca-
pacity indirectly. The main advantages of walking tests are
simplicity, minimal resource requirements, and general appli-
cability. The six-minute walk test distance has moderate but
significant correlation with VO2 max in patients with
90 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE
end-stage lung disease [19]. This self-paced test is performed
in an indoor corridor. Rest stops are allowed and subjects con-
tinue to wear their oxygen, while systemic responses of oxy-
gen saturation and heart rate are measured. The distance
walked is measured and a rating of breathlessness and leg fa-
tigue is assessed at the end. The minimum clinically important
difference has also been studied and shown to be 43-54 meters
[20], [21]. The main disadvantages of timed walking tests are
patient and administrator motivation, the effects of learning,
and potential for intertest variability if the administrator(s)
gives differing instructions or encouragement during separate
tests over time [22]. Depending on the patient and severity of
lung disease, a six-minute walk may or may not represent
maximal exercise achieved. For example, one subject may
walk a greater distance without rests or supplemental oxygen
with minimal breathlessness at the end of six minutes, com-
pared to another subject who is wearing oxygen and needs to
rest three times during the six minutes and walks a shorter dis-
tance. Furthermore, the six-minute walk does not discriminate
among patients with mild impairments in exercise capacity.
Ambulatory Monitoring of Exercise
and Free-Living Activity in COPD
Accurate measurement of exercise capacity is important in as-
sessing the patient with COPD. Patients with COPD have
large, daily variability in their clinical status, with “good and
bad days” being functions of secretions or weather humidity.
However, current methods of measuring exercise capacity,
such as the six-minute walk and cardiopulmonary exercise
tests, are limited by their assessment of the patient at one point
in time in a controlled laboratory environment. These tests
also only assess level-ground walking, which is not indicative
of ambulatory tasks in real-life situations.
Devices are being developed to identify movement and
physiological variables outside of the laboratory environ-
ment. A variety of compact wearable sensors are available to-
day. Specific examples of these devices are briefly
summarized to demonstrate the state of the art.
The SenseWearTM Pro Armband (BodyMedia, Inc.) is a
sleek, wireless, wearable body monitor that enables continu-
ous physiological and lifestyle data collection outside the lab-
oratory environment. Worn on the back of the upper arm, it
utilizes a combination of sensors and technologies that gath-
ers raw physiological data such as movement, heat flow, skin
temperature, near body ambient temperature, heart rate, and
galvanic skin response. The SenseWear Pro Armband con-
tains a two-axis accelerometer, temperature sensors for moni-
MAY/JUNE 2003
 Assessing systemic response and
monitoring specific motor patterns
in the field over extended periods of time
would provide a comprehensive
view of the active patient.
toring heat fluctuation, skin temperature, near body ambient
temperature, galvanic skin response, and heart rate received
from a Polar MonitorTM system.
The armband can be worn continuously up to three days
without recharging the battery, and it stores up to five days of
continuous physiological and lifestyle data. Research soft-
ware is available to offer audio and tactile feedback for re-
minders, targets, and alerts. Its ability to provide two-way
communication makes the armband a hub for collecting data
from other third-party products such as a weight scale or a
blood pressure cuff. The manufacturer promotes the product
as “eliminating the need for researchers and clinicians to ad-
minister and apply cumbersome sensors to their research sub-
jects.” The main limiting factor of this system is the low
sampling rate.
LifeShirt™, by VivoMetrics, is a comfortable, washable
“shirt” that contains numerous embedded sensors that contin-
uously monitor 30+ physiological signs of sickness and
health. The garment can be worn at home, work, or play. The
list of physiologic functions it monitors includes: EKG, respi-
ration, BP, PO2, and posture. Data from the sensors are re-
corded to a small belt-worn recorder where they are encrypted
and sent to VivoMetrics Data Center by cellular telecommuni-
cation. There they are decrypted, scanned for artifacts, and
posted in a database where summary reports can be generated
for the client.
The Smart Shirt (http://www.sensatex.com/) is a wearable
health monitoring system by Sensatex, Inc, USA, that moni-
tors EKG, temperature, motion, position, barrier penetration,
etc. The monitoring system is designed as an undershirt with
various sensors embedded within it. Data are transmitted to a
pager-sized device attached to the waist portion of the shirt
where it is sent via a wireless gateway to the Internet where it
is routed to a data server where the actual monitoring occurs.
The Smart Shirt incorporates a patented technology named
“Wearable Motherboard” that incorporates optical fibers, data
bus, microphone, sensors, and a multifunction processor, all
embedded in a basic textile grid that is launderable. The main
limitation of the LifeShirt and the Smart Shirt is that these sys-
tems do not allow positioning of accelerometers (ACC) and
EMG sensors on upper and lower limbs.
ACCs have been used to monitor motor functions in
healthy individuals and patients [23]. Paolo Bonato and his
laboratory at the Spaulding Rehabilitation Hospital, Boston,
use the Vitaport3 by Temec (http://www.temec.nl/in-
dex.html), which is a modular digital recorder marked by low
energy consumption. This system has been interfaced with
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ACC sensors and utilized successfully to assess levodopa-in-
duced dyskinesia in patients with Parkinson’s Disease [24].
In collaboration with Professor Bonato, we studied a
77-year-old man with severe COPD with forced expiratory
volume in 1 s (FEV1) of 1.3 liters (43 % predicted). He uses
supplemental oxygen and is maintained on albuterol and
atrovent inhalers. He completed a pulmonary rehabilitation
program at Brigham and Women’s Hospital, Boston, five
years ago. He attends the pulmonary rehabilitation support
group once a month; he is able to walk on a treadmill for
15-20 minutes. For the tasks comprising the Identification
set, continuous recordings of 10 minutes each were obtained
in the laboratory while the subject 1) walked on a treadmill,
2) rode a stationary bicycle, and 3) used an arm ergometer. A
set of extraneous tasks (Non-Identification set), including
standing, sitting, and stacking books on a table, were also re-
corded for five minutes each to validate the robustness of the
processing techniques.
While performing the tasks, the patient wore four uniaxial
ACCs on the right and left forearm and on the right and left
thigh. In addition, a total of four electromyography (EMG)
sensors were located on the right and left biceps brachii and
the right and left rectus femoris of the subject. The analog out-
puts of all sensors were digitized and recorded using the
Vitaport3 ambulatory system. Figure 1 shows examples of the
ACC data traces from this patient for the three Identification
tasks. Motion patterns that distinguish these tasks are evident
in the plots.
Walking Arm Ergometer Bicycling
R Arm
L Arm
R Leg
L Leg
1s
Fig. 1. Examples of the ACC data traces from a 77-year-old
man with severe COPD with forced expiratory volume in 1 s
(FEV1) of 1.3 liters (43 % predicted) for three identification
tasks.
MAY/JUNE 2003 91
 Ambulatory monitoring would allow
continued exercise training at home,
alone, or in combination with intermittent
office-based supervised training.
To automatically recognize these patterns, we imple-
mented an artificial neural network (ANN). For each task per-
formed, epochs were chosen by randomly positioning a 4-s
rectangular window through the entire data set by steps of 0.5
s to avoid reliance of task detection on epoch selection. Labo-
ratory data were processed and used to train pattern recogni-
tion algorithms to identify the ambulatory motor tasks. The
processing algorithms automatically determined which tasks
were being performed and when during the field data collec-
tion. Sufficient data were available to provide 100 independ-
ent examples of each of the identification tasks and 50
independent examples of each of the nonidentification tasks.
In addition, we evaluated the performance of the system
using a reduced array of four ACCs, because of the consider-
able usability advantages of such a configuration. The topol-
ogy of the ANN consisted of one input node for each feature,
10 hidden layer nodes, and three output nodes, each of which
corresponds to one of the identification tasks. To estimate the
ANN’s performance on novel data, we presented 50 examples
each of the three identification tasks and three nonidentifica-
tion tasks, for a total of 300 examples. Ideally, the ANN re-
sponse to an identification task input should be 1 at the output
node corresponding to the task and 0 at the other output nodes.
The network’s response to a nonidentification task input can
vary considerably, but in general it does not conform to this
type of pattern. Hence, to choose the identified task for a par-
ticular example, we calculated the distance between the actual
output for that example and the ideal orthogonal pattern and
then chose the task that minimized such distance. Further, to
reject examples corresponding to nonidentification tasks, we
set a threshold and kept only those identifications whose dis-
tance fell below the threshold. For the full array of sensors (4
EMG + 4 ACC) we obtained sensitivity of 97.33% with zero
misclassifications and 100% specificity. For the reduced array
of 4 ACC, the sensitivity and specificity were identical to
those of the full array, while the misclassification rate in-
creased slightly to 4%.
Ambulatory monitoring of daily free-living exercise in
COPD patients would potentially enhance their care. Use of
methods to assess systemic response along with the ability to
monitor specific motor patterns in the field over extended pe-
riods of time would provide a comprehensive view of the ac-
tive patient. Coupling these methods with remote access to the
data via wireless technology would dramatically augment
current clinical tools for healthcare providers to assess pa-
tients with COPD. Timely medical intervention could be
made based on early detection of changes in physiological re-
sponses to exercise, such as heart rate and oxygen saturation.
Potential clinical applications include: 1) enhancement of
compliance with exercise regimens outside of a supervised
setting, 2) decrease length of hospital stay by monitoring pa-
92 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE
tients from a distance, 3) use in preoperative risk assessment
to accurately reflect a patient’s clinical status, and 4) use in
clinical trials to monitor responses to drug therapy. The re-
mainder of this article will focus on potential clinical applica-
tions of monitoring cumulative free-living activity in patients
with COPD.
Improved Compliance with Exercise
and Impact on Current Therapies for COPD
Treatment with pulmonary rehabilitation has been advocated
to improve exercise tolerance and is a major component of
medical therapy for COPD [25]. Pulmonary rehabilitation has
been shown to improve symptoms, exercise capacity, and
HRQL, even in the absence of improvement in lung function
[16], [26]-[28]. It has been shown that these benefits are maxi-
mal at the completion of training and are maintained over the
following several months. Although the benefits declined
gradually over time, significant improvements over baseline
persisted one year following the training period. Significant
improvements in exercise tolerance and symptoms have been
demonstrated convincingly in patients with COPD up to one
to two years following a limited-duration (6-12 weeks) reha-
bilitation program that includes exercise training [6].
However, access to a supervised program may not be avail-
able to many patients who live at a distance from a medical
center. With the use of ambulatory monitoring of exercise, a
remotely supervised exercise program could be initiated and
monitored for those who do not have access to a pulmonary
rehabilitation site. Furthermore, for those who have com-
pleted a supervised program, compliance with continued ex-
ercise in the home environment is unknown. The optimal
means of maintaining the maximal benefits achieved remain
unknown. Ambulatory monitoring would allow continued ex-
ercise training at home, alone, or in combination with inter-
mittent office-based supervised training. The immediate
feedback to the patient of exercise performed as well as avail-
ability of the data to healthcare providers would potentially
improve compliance with maintenance exercise, with preser-
vation of maximal benefits achieved over the long term.
Lung transplantation is a suitable surgical treatment for
a subset of patients with COPD. It has been shown to im-
prove lung function, exercise capacity, and HRQL. Exer-
cise capacity is also used as a marker of physical
conditioning and as a predictor of successful outcomes af-
ter lung transplantation [29]. All candidates must be ambu-
latory [30] and must participate in a supervised pulmonary
rehabilitation program [16]. Preoperative exercise training
and muscle strengthening programs are required by all
transplant centers [30]. One study indicated that a preoper-
ative six-minute walk distance less than 300 meters is pre-
dictive of a poor outcome [31]. A minimum walking
MAY/JUNE 2003
 Measurement of cumulative free-
living activity may prove to be
optimally used alone or in conjunction
with existing measures of clinical status.
distance on the six-minute walk test is used as the criterion
for listing patients for lung transplantation. Patients are ex-
pected to adhere to an exercise regimen both while waiting
on the transplant list and after lung transplantation.
After transplantation, patients have a high incidence of
pulmonary and extra-pulmonary infections as well as acute
rejection [29]. It has been hypothesized and clinically ob-
served that compliance with an exercise regimen after trans-
plantation is critical to the function of the allograft in terms of
chest wall-lung interactions, clearance of secretions, and re-
spiratory muscle strength. After lung transplantation, poor ex-
ercise performance is related to limited limb muscle
endurance associated with deconditioning but also possibly
due to the effects of the immunosuppressive regimen of
corticosteroids (myopathy) and cyclosporine (impaired mus-
cle vasodilation) [30]. It has been observed that patients with
osteopenia or osteoporosis experience further decline in bone
density associated with the effects of glucocorticoids and
cyclosporine. Thirty seven percent of lung transplant recipi-
ents sustained at least one fracture (most commonly ribs and
vertebrae) during a one-year observation after transplantation
[32]. The myopathy and loss of bone density need to be ac-
tively countered by weight-bearing exercise.
Pretransplant exercise capacity is assessed by the six-min-
ute walk and cardiopulmonary exercise testing, with the limi-
tations already discussed. While waiting on a transplant list
and after transplant, the majority of exercise is performed at
home and self-reported. Furthermore, it is not feasible for a
subset of transplant patients to travel great distances to partici-
pate in a supervised exercise program. These patients also
need to wear a mask when in the presence of other people dur-
ing the first year after transplantation, a necessity that makes
exercising in a supervised pulmonary rehabilitation program
difficult since they easily become breathless when wearing
the mask and exercising simultaneously. Ambulatory moni-
toring of exercise would potentially provide an accurate as-
sessment of exercise capacity to predict a successful
transplant outcome and to detect early changes in clinical sta-
tus after transplant, improve compliance with exercise after
transplant resulting in a decreased incidence of morbid com-
plications from immunosuppression, and provide a super-
vised exercise program for those who cannot travel to a
pulmonary rehabilitation site.
Effect on Hospital Length of Stay
With the rising cost of medical care, any decrease in the hospi-
tal length of stay would be cost saving to the individual, the
hospital, and society in general. Patients with COPD are most
commonly admitted to the hospital for exacerbations, infec-
tions, or chest surgery. It is estimated that approximately
US$10 billion annually is spent in hospitalization costs re-
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lated to management of exacerbations of COPD [33]. In the
hospital, patients are encouraged to walk to prevent
deconditioning related to surgery and myopathy related to
corticosteroids used to treat exacerbations. Prolonged air
leaks and hospital-acquired tracheobronchitis or pneumonia
are common causes of delayed discharge in patients with
COPD undergoing chest surgery. Thoracic surgery involves
cutting across the pleura and lung tissue; thus, air leaks into
the pleural space from the lung parenchyma until it heals. Pa-
tients with COPD have bullae, pockets of enlarged airspaces,
that easily rupture into the pleural space. They may also have
been on high doses of corticosteroids for exacerbations. Both
the presence of bullae and the exposure to corticosteroids de-
lay tissue healing, resolution of air leaks, and ultimately dis-
charge from the hospital. Walking is advocated to heal air
leaks by increasing tidal volumes to reapproximate the lung
and pleura to the chest wall; walking also allows mobilization
of secretions to prevent infections.
Self-assessment or assessment by medical staff of how
long and how far a patient walked on a given day is subject to
recall errors and inaccuracies of perception of time and dis-
tance confounded by shortness of breath and overall
deconditioning. Ambulatory monitoring of free-living cu-
mulative exercise could be used to establish each patient’s
baseline exercise capacity during a stable clinical period in
the home environment. A targeted exercise plan during a
hospital admission could then be devised based on the pa-
tient’s baseline free-living activity. Such a targeted exercise
plan with accurate monitoring of the walking performed in
the hospital would potentially improve compliance with ex-
ercise, aid in the clinical assessment of improvements to-
ward baseline, and ultimately decrease hospital length of
stay. Improved compliance with walking may decrease the
time to healing of air leaks, risk of pulmonary infections, and
length of hospital stay.
Furthermore, the threshold for a patient to return to his
home environment safely may be lower, leading to an earlier
discharge if medical staff were able to monitor the patient’s
exercise capacity and systemic responses to exercise from a
distance via wireless technology. A discharged patient able to
walk and maintain his baseline oxygen saturation and heart
rate is continuing on the road to recovery. A patient who is not
walking and has a low oxygen saturation may need to be read-
mitted to the hospital. Changes in physiological responses to
exercise, such as heart rate and oxygen saturation, may be de-
tected as an early sign of clinical decline allowing timely med-
ical intervention.
Use in Preoperative Risk Assessment
Most lung resection candidates in industrialized nations suffer
from lung cancer. Most of them are former or current smokers
MAY/JUNE 2003 93
 With ambulatory monitoring, a
remotely supervised exercise program
could be initiated and monitored for
those who do not have access
to a pulmonary rehabilitation site.
and therefore are at risk for COPD and coronary artery dis-
ease, conditions associated with increased surgical morbidity
and mortality. These patients are at higher than usual risk for
prolonged mechanical ventilation, hospital-acquired pneumo-
nia, and pulmonary edema from volume overload. On the
other hand, lung cancer mortality approaches 100% when not
treated surgically, so that limited postoperative complications
may be acceptable unless they are fatal [34]. Accurate means
to assess operative risk are crucial for patients and healthcare
providers to make a decision on the risks and benefits of surgi-
cal treatment. Poor exercise performance is a generally ac-
cepted risk factor for postoperative complications [35].
Exercise capacity has been shown to be a predictor of success-
ful outcomes after thoracic surgery and lung volume reduc-
tion surgery in patients with COPD [36]-[39]. Cardio-
pulmonary exercise testing has become popular to assess the
surgical risk since it was demonstrated that the maximal oxy-
gen uptake during symptom limited exercise was a much
better predictor of operative mortality than tests of ventilatory
mechanics [40]. A preoperative VO2 max of greater than
20mL/kg/minute generally is accepted as safe for any resec-
tion up to a pneumonectomy, and a value less than 10
mL/kg/minute is considered to be predictive for a high com-
plication rate, irrespective of the extent of resection.
Given the limitations of current methods to measure exer-
cise capacity, ambulatory monitoring of cumulative free-liv-
ing activity over an extended period of time may provide more
valid information to allow risk stratification for any major
thoracic or extrathoracic surgery.
Use as Outcome in Clinical Trials
Lung function, or specifically the FEV1, is often used in clini-
cal trials because it is noninvasive, relatively inexpensive, and
highly reproducible [41]. However, the relationship between
FEV1 and functional status and clinical status is highly vari-
able [42]. In addition to lung function, common endpoints
include HRQL that is subject to patient recall over the preced-
ing 2-4 weeks, exercise capacity as measured by six-minute
walk distance that is assessed at one point in time, and self-re-
ported symptoms such as breathlessness. New outcomes vari-
ables are needed in large clinical trials of drug therapies in
COPD to assess clinical status and response to therapy. Be-
cause it is averaged over an extended period of time, cumula-
tive free-living activity may more accurately reflect the
subject’s exercise capabilities and may be more valid, reliable,
and responsive to change over time than current outcomes.
Continuous monitoring would allow detection of any change
94 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE
in clinical status or adverse events to the study drug or
withdrawal of other medications as part of the trial. Episodic
measurements of the duration of time spent performing speci-
fied activities, the distance walked or biked, the systemic re-
sponse, or energy expenditure may be used as trial outcomes.
Conclusion
The ability to measure cumulative free-living activity in pa-
tients with COPD appears to have enormous potential clinical
applicability. Ongoing research to develop unobtrusive, wear-
able sensors that extend monitoring periods and couple these
data with wireless technology is needed. Research studies are
also needed to assess the role measurement of cumulative
free-living activity plays in both the clinical care of patients
with COPD and clinical trials involving COPD therapeutics.
It may prove to be optimally used alone or in conjunction with
existing measures of clinical status.
Marilyn L. Moy received the A.B. degree in biology from Har-
vard and Radcliffe Colleges in 1988, the M.D. from Harvard
Medical School in 1992, and the M.Sc. in epidemiology from
the Harvard School of Public Health in 2000. Dr. Moy com-
pleted a fellowship in pulmonary and critical care medicine at
the Brigham and Women’s Hospital in Boston, Massachusetts,
where she is currently an associate physician. Dr. Moy is a
member of the Lung Transplantation Program and an instructor
in medicine at Harvard Medical School. Her principal research
interests include patient-centered outcomes, such as health-re-
lated quality-of-life and exercise capacity, and physiologic re-
sponses to surgical therapy in obstructive lung diseases. Dr.
Moy is the recipient of the GlaxoSmithKline Development
Partners’ Junior Faculty Award (2001-2003).
Steven J. Mentzer received the A.B. degree in English from
Dartmouth College in 1977 and the M.D. from Harvard Medi-
cal School in 1981. He completed a fellowship in thoracic sur-
gery at the University of Toronto. Dr. Mentzer is currently a
member of the Lung Transplantation Program at Brigham and
Women’s Hospital in Boston, Massachusetts, and associate
professor of surgery at Harvard Medical School.
John J. Reilly received the A.B. degree in chemistry from
Dartmouth College in 1977 and the M.D. from Harvard
Medical School in 1981. Dr. Reilly completed a fellowship
MAY/JUNE 2003
in Pulmonary and Critical Care Medicine at the Brigham
and Women’s Hospital in Boston, where he is currently the
clinical director of the Pulmonary and Critical Care Divi-
sion, medical director of Pulmonary Rehabilitation, medi-
cal director of the Center for Chest Diseases, and a member
of the Lung Transplantation Program. He is an associate
professor of medicine at Harvard Medical School. He is the
principal investigator for the BWH site of the National Em-
physema Treatment Trial. Dr. Reilly is involved in physio-
logic studies directed at elucidating the influence of
airways disease on response to surgical therapy in COPD,
studies of genetic factors associated with the development
of COPD, and studies of alveolar macrophage associated
proteases in subjects with COPD.
Address for Correspondence: Marilyn Moy, Brigham and
Women’s Hospital, Pulmonary and Critical Care Medicine,
75 Francis Street, Boston, MA 02115 USA. E-mail:
mmoy@partners.org.
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