Superior Efficacy of Activity Monitors over Pedome

Superior Efficacy of Activity Monitors over Pedome
Hindawi Publishing Corporation
Journal of Diabetes Research
Volume 2016, Article ID 5043964, 7 pages
http://dx.doi.org/10.1155/2016/5043964
Publication Year 2016
Research Article
Exercise Therapy for Management of Type 2 Diabetes Mellitus:
Superior Efficacy of Activity Monitors over Pedometers
Masaaki Miyauchi, Masao Toyoda, Noriko Kaneyama, Han Miyatake, Eitaro Tanaka,
Moritsugu Kimura, Tomoya Umezono, and Masafumi Fukagawa
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine,
Kanagawa, Japan
Correspondence should be addressed to Masao Toyoda; [email protected]
Received 3 March 2016; Revised 21 August 2016; Accepted 6 September 2016
Academic Editor: Gianluca Castelnuovo
Copyright © 2016 Masaaki Miyauchi et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
We compared the efficacy of activity monitor (which displays exercise intensity and number of steps) versus that of pedometer
in exercise therapy for patients with type 2 diabetes. The study subjects were divided into the activity monitor group (𝑛 = 92)
and pedometer group (𝑛 = 95). The primary goal was improvement in hemoglobin A1c (HbA1c). The exercise target was set at
8,000 steps/day and 20 minutes of moderate-intensity exercise (≥3.5 metabolic equivalents). The activity monitor is equipped with
a triple-axis accelerometer sensor capable of measuring medium-intensity walking duration, number of steps, walking distance,
calorie consumption, and total calorie consumption. The pedometer counts the number of steps. Blood samples for laboratory tests
were obtained during the visits. The first examination was conducted at the start of the study and repeated at 2 and 6 months. A
significant difference in the decrease in HbA1c level was observed between the two groups at 2 months. The results suggest that the
use of activity level monitor that displays information on exercise intensity, in addition to the number of steps, is useful in exercise
therapy as it enhances the concept of exercise therapy and promotes lowering of HbA1c in diabetic patients.
1. Introduction
Diet and exercise therapy form the basis of treatment of type
2 diabetes mellitus (T2DM). These two approaches are well
known to improve blood glucose control [1]. Exercise therapy
has also been reported to be effective in improving blood
glucose control and quality of life (QOL) [2, 3]. However,
reduction of fat and improvement in insulin resistance are
limited with diet modification alone [4].
As such, even while the effects of exercise therapy are well
known, in reality, even when diet therapy is followed nearly by
all patients, the percentage of patients who adhere to exercise
therapy is only about 40% [5]. The reasons for this low rate
are that exercise therapy is not easy to implement in patients
with no physical training background, time restrictions, and
inability to maintain motivation. Another reason is that the
actual techniques and goals of exercise therapy are often
difficult to understand by both the patient and the instructor.
Target indicators for exercise therapy include both the
number of steps and strength [5], and moderate-intensity
training is considered particularly effective. While 3–6
metabolic equivalents (METs) are proposed for exercise
therapy of moderate intensity [5, 6], in actuality, checking the
intensity level during training sessions is often difficult. For
effective exercise therapy, the activity level should be appropriately increased by monitoring and being aware of the exercise intensity. Development of a simple and useful tool toward
this end would help improve the outcome of treatment of
T2DM. Using a conventional device that measures the number of steps (pedometer) and another device that measures
the number of steps and exercise intensity and amount (activity monitor), the present study was designed to evaluate the
effects of exercise therapy with awareness of training intensity
with regard to improvement in blood glucose control.
2. Materials and Methods
2.1. Patients and Methods. The subjects were 200 adult
patients with T2DM who visited our division at Tokai
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Red line (moderate intensity)
Goal achievement sign
(“banzai character”)
Steps
Total
consumption
day before
min
km
Steps
kcal
min
Memory
Set
km
Mode
kcal
(a)
0 months
Measurement of HbA1c
Clinical laboratory tests
(b)
After 2 months
Measurement of HbA1c
Clinical laboratory tests
After 6 months
Measurement of HbA1c
Clinical laboratory tests
Reporting of the number of steps
Instructions on exercises
Collection of record notebooks
Reporting of the number of activities
Instructions on exercises
Collection of record notebooks
Activity monitor
group
Instructions on exercises
Pedometer
group
Instructions on exercises
(c)
Figure 1: (a) On the activity monitor, for exercise of moderate intensity of 3 METs or higher, the intensity is displayed when the indicator
exceeds the red line. (b) If the daily goal of moderate-intensity exercise of 20 minutes or longer and at least 8,000 steps is set and achieved,
the user is notified that the goal has been achieved through a sign on the screen (a “banzai character”). (c) Study design.
University Hospital between March and April 2012 and were
judged by their physicians as fit to receive exercise therapy.
In addition, at the beginning of the study, the methods
and purpose of the research and the voluntary nature of
cooperation were explained verbally and in writing, and
written agreement was obtained from all patients. This study
was registered as a clinical trial (UMIN000018694), with the
inspection and approval of the institutional review board for
clinical research of Tokai University Hospital.
The number of steps and amount of physical activity
were recorded digitally using an activity monitor (model MTKT01, Terumo, Tokyo, Japan) with a triaxial speed sensor that
measures the number of steps and the time spent walking at
a moderate-intensity level. Another device, a modified MTKT01, was used as a pedometer to count the number of steps
during walking/exercise.
After randomly assigning 100 subjects each to the activity
monitor group and the pedometer group, a target was set
for the pedometer group, which was walking exercise of
moderate intensity (3 METs or higher) for least 20 minutes a
day and 8,000 steps. The same target of at least 3 METs (at or
above the achievement line indicator in the activity monitor;
Figure 1(a)) for a minimum of 20 minutes a day of exercise
and 8,000 steps was also set for the activity monitor group.
Both the pedometer and activity monitor were hung from a
strap around the user’s neck during waking hours.
The achievement of the target exercise was signaled by
a display of the goal achievement sign (Figure 1(b)) on the
activity monitor. The patients were asked to manually record
the data of their activity monitor and pedometer in record
sheets, which were collected during the outpatient visits.
Clinical data measurements, including HbA1c level, were
performed during the outpatient visits, with evaluation of the
number of steps and target achievement ratio in the second
month and final evaluation in the sixth month (Figure 1(c)).
Instructions were provided regarding the exercise on a
pamphlet handed to each patient (Figure 2) at the beginning
of the study. At 2 months after the start of training, the
subjects were asked to report the number of steps and amount
of exercise, as well as whether they had achieved the set
targets. Those who self-reported that they had achieved the
goals were instructed to continue, while those who had not
done so were again provided information described in the
pamphlet without any new intervention.
2.2. Statistical Analysis. The 187 patients who completed
their 6-month follow-up were the subjects of the analysis
(Figure 3). The pedometer and activity monitor data were
compared, as well as changes in medications. Concerning
continuation of exercise and achievement of targets, the
analysis defined those with at least 80% of day count data and
at least 80% of target exercise amounts as meeting the goals.
Journal of Diabetes Research
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“Perform moderate-intensity exercise (approximately 3 METs)”
(i) Perform moderate-intensity exercise for at least 20 minutes per day.
(ii) Set the target for the number of steps at 8000 steps or more.
(iii) Do not exercise too strenuously on a day on which you do not feel
well.
Specific targets
for exercise
“What kind of exercise is moderate-intensity exercise (approximately 3 METs)?”
Recommended exercise is quick walking. The walking speed at which
while talking you feel a little strenuous is appropriate.
Quick walking (speed: approximately 70 to 90 m/min)
Note: the average walking speed of elderly people (65 years
of age or older) is “approximately 55 m/min.”
Examples of 3 METs
Taking a dog for a walk
Walking
Shopping
Figure 2: The explanatory pamphlet for exercise therapy. Examples of moderate-intensity exercises for the patients who participated in the
study of both the activity monitor and the pedometer groups. The exercise goal of at least 20 minutes and 8,000 steps a day was based on the
pamphlet.
Table 1: Clinical characteristics of the activity monitor group and pedometer group.
Age (years)
Male
Height (m)
Weight (kg)
BMI
HbA1c (%)
Systolic BP (mmHg)
Diastolic BP (mmHg)
UA (mg/dL)
HDL cholesterol (mg/dL)
LDL cholesterol (mg/dL)
Triglycerides (mg/dL)
Activity monitor group (𝑛 = 92)
62.7 ± 9.2
78.3%
1.63 ± 0.08
72.6 ± 15.7
27.2 ± 5.1
7.1 ± 1.1
122.8 ± 11.1
70.9 ± 9.3
6.0 ± 1.5
59.9 ± 17.2
108.7 ± 24.9
151.1 ± 103.8
Pedometer group (𝑛 = 95)
62 ± 10.6
56.8%
1.62 ± 0.09
69.1 ± 15.4
26.4 ± 5.4
7.0 ± 1.2
123.0 ± 10.9
71.9 ± 9.5
5.3 ± 1.3
60.9 ± 19.7
112.0 ± 23.9
138.3 ± 75.9
𝑝 value
0.97
<0.005
0.12
0.11
0.21
0.53
0.98
0.79
<0.005
0.85
0.60
0.49
Values are mean ± SD.
BMI: body mass index; BP: blood pressure; UA: uric acid; HDL: high-density lipoprotein; LDL: low-density lipoprotein.
The HbA1c levels at the beginning of the study and
at 2 and 6 months later were compared as main items by
performing responsive examination. The Pearson chi-square
test or Mann-Whitney 𝑈 test was used for comparison of
variables between the two groups, and the significance level
was set at 5%. The statistical analysis software used was JMP
Ver. 11.0.0 (SAS Institute Japan, Tokyo).
3. Results
3.1. Patients Background Characteristics and Changes in
HbA1c Level. The clinical background data of the 187 patients
who completed the 6-month follow-up are summarized in
Table 1, and the delta changes in HbA1c level during the study
are shown in Figure 4(a).
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Process of selection of target patients
200 patients:
Number of subjects enrolled into our
hospital from March to October 2012
Table 1, Figure 4(a)
187 patients:
Completed 6 months of follow-up
Table 2, Figure 4(b)
28 patients:
Did not change medications during 6
months before and after the start
13 patients:
Discontinued or transferred to
another hospital
55 patients:
Patients for whom the data of the
records of the activity monitor or
the pedometer were not available.
73 patients:
Failed to achieve the exercise target
30 patients:
Changed antidiabetes drugs during
6 months before and after the start.
Figure 3: Patient selection process. After excluding those patients who cancelled, transferred to other hospitals, or dropped out, the data of
187 patients were subjected to analysis. After excluding patients with insufficient exercise therapy record data, unachieved exercise goals, and
changes in medications in the 6 months before and after the start of the study period, data of 28 patients of each group were compared and
studied.
0.20
0.20
0.10
0.10
−0.10
p < 0.05
−0.20
−0.24 ± 0.39∗
−0.30
−0.31 ± 0.48∗
NS
−0.40
−0.37 ± 0.57∗
−0.50
0
2
(months)
−0.01 ± 0.23
0.00
−0.08 ± 0.42
6
ΔHbA1c (%)
ΔHbA1c (%)
0.00
−0.08 ± 0.29
−0.10
p < 0.05
−0.20
NS
−0.24 ± 0.16 ∗
−0.30
−0.40
−0.50
0
Pedometer group (n = 95)
Activity monitor group (n = 92)
8023.7 steps/day
7857.3 steps/day
∗p
< 0.001 versus 0 months
(a)
6
NS
10847 steps/day
∗p
< 0.001 versus 0 months
∗∗ p
NS: not significant
2
(months)
Pedometer group (n = 14)
Activity monitor group (n = 14)
10314 steps/day
NS
−0.28 ± 0.50∗∗
NS: not significant
< 0.05 versus 0 months
(b)
Figure 4: (a) Changes in HbA1c level after daily walking exercise for 2 and 6 months in the pedometer and activity monitor groups and all
187 patients. (b) Changes in HbA1c level after daily walking exercise for 2 and 6 months in 28 patients of the pedometer and activity monitor
groups who achieved their goals and recorded no changes in medications throughout the study.
Based on the background characteristics of all the 187
patients, no clear difference was found between the two
groups other than a significant preponderance of men in the
activity monitor group and the value of uric acid in the blood
being significantly low in the pedometer group (Table 1).
With regard to changes in HbA1c level, significant reductions in HbA1c level at 2 and 6 months after the start of the
study were observed in the activity monitor group, compared
to that before the start of study. Comparison of data of the two
device groups showed a significant difference in the level of
reduction in HbA1c level at 2 months between the pedometer
and activity monitor groups (pedometer group: 0.08 ± 0.42%,
activity monitor group: 0.24±0.39%). However, no significant
difference was observed between the two groups at 6 months.
Changes in HbA1c at 2 and 6 months were also compared
according to sex and uric acid level. There was no significant
Journal of Diabetes Research
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NS
NS
Reduction in HbA1c (%)
0.5
NS
0.4
0.3
0.2
0.44 ± 0.52
0.42 ± 0.50
NS
0.31 ± 0.60
0.25 ± 0.42
0.25 ± 0.35
0.22 ± 0.37
0.19 ± 0.54
0.20 ± 0.74
0.1
2 months
Low UA
High UA
Female
Male
Low UA
High UA
Female
Male
0
6 months
UA: uric acid
NS: not significant
Figure 5: Comparison of the levels of reduction in HbA1c at 2 and
6 months according to sex and serum uric acid.
difference in HbA1c between males and females (Figure 5).
After dividing the patients into those with high and low uric
acid levels, using the median uric acid level as the cutoff value,
we found no difference between the two groups (Figure 5).
Next, we excluded the data of 55 subjects with physical
activity data less than 80% of those recorded at 6 months
and 73 subjects with physical activity data less than 80%
of the exercise target achievement rate. Thus, 59 patients
continued the exercise therapy for 6 months, including 36 of
the activity monitor group and 23 of the pedometer group.
The continuation rate was 37.9% and 25.0%, respectively. The
exercise therapy continuation rate of the activity monitor
group was significantly better than that of the pedometer
group (𝑝 = 0.0282).
Since no limitation was imposed in the present study on
the use and changes in medications, the effects of the drugs
were excluded. For meaningful analysis, however, we selected
those patients in whom no changes in medications were made
6 months before and after the start of the study (i.e., for 1
year) and analyzed their data for the effects of exercise therapy
only. The results showed that changes in HbA1c level purely
due to exercise were noted in 14 subjects from each group
(Figure 4(b)).
Significant reductions in HbA1c level from the time
before to the time after the start of the study were observed in
the activity monitor group but not in the pedometer group
both at 2 and at 6 months. The decrease in HbA1c level
at 2 months was significantly larger in the activity monitor
group (0.24 ± 0.16%) compared with the pedometer group
(0.01±0.23%). A similar trend was noted at 6 months, though
the difference was not significant.
4. Discussion
The US guidelines recommend 150 minutes of exercise per
week as appropriate exercise therapy. However, a recent study
indicated that 90 minutes per month of low to moderate
exercise is beneficial in Asians [7]. Thus, fast walking,
which can be easily achieved on a daily basis, is considered
moderately intense exercise in Asia. For this reason, this study
was conducted by selecting walking exercise as the exercise
therapy, which is considered the easiest to perform. This study
was planned with a hypothesis that, as a resolution to the issue
of “I do not have time to exercise,” changing the daily activity
itself to a level of moderate intensity is a sufficient exercise
therapy, even if one just cannot take time to exercise, and
that activity monitors have better results than pedometers as
a measure of exercise efficacy.
The target activity was set in the present study at 3 METs,
although moderately intensive exercise is effective in exercise
therapy in T2DM patients [8]. Unconditionally speaking,
even for moderate-intensity exercise, the exercise burden
should be adjusted according to age. For those patients aged ≥
65 years (constituting the majority of our patients and representing the majority of patients with T2DM in Japan), the 3MET level is considered of moderate intensity [6]. We therefore set 3 METs and higher as the target activity in this study.
Our results showed reduction of HbA1c level in both
groups when the patients of both groups exercised while
being aware of the 3-MET target. These results confirmed
that exercise therapy, at least for 6 months, contributed to the
improvement in HbA1c in patients with T2DM. Furthermore,
patients who wore the activity monitor, which provided feedback about their exercise intensity, also showed reduction in
HbA1c level, which was significantly better at 2 months compared with the pedometer group. This difference was thought
to be due to the motivation to exercise at a moderate level,
combined with feedback from checking exercise intensity,
with resultant more beneficial effects in the activity monitor
group than the pedometer group. Considered together, these
results suggest that the use of activity monitor seems to
enhance the reduction in HbA1c level.
As shown in Figure 4(b), in the study that excluded
the effects of medications, the decrease in HbA1c level was
interestingly larger in the activity monitor group than in
the pedometer group at both 2 and 6 months. This finding
suggests that using an activity monitor is important in
exercise therapy, as it provides information about exercise
intensity, and that such monitor is particularly effective in the
simple exercise therapy of walking as part of daily activities.
Furthermore, the most noteworthy result of this study
was the difficulty of continuing the exercise therapy in the
6-month study period. Thus, the percentage of patients who
continued exercise therapy for 6 months at ≥80% of the
exercise therapy was less than 40% in both groups: 37.9% of
the activity monitor group and 25.0% of the pedometer group,
indicating the difficulty in continuing exercise therapy itself.
Based on these results, we emphasize the need for motivating
T2DM patients to continue exercise.
With regard to the provision of instructions or guidance
to the patients regarding exercise therapy, in addition to
its usefulness in maintaining motivation through the ability
to recognize exercise intensity levels, even in patients who
received instructions through the pamphlet only, checking
that the target of 3 METs has been achieved during walking is useful in learning the appropriate walking speed.
6
Journal of Diabetes Research
Table 2: Clinical background of patients in whom medications were not changed throughout the study.
Age (years)
Male
Height (m)
Weight (kg)
BMI
HbA1c (%)
Systolic BP (mmHg)
Diastolic BP (mmHg)
UA (mg/dL)
HDL cholesterol (mg/dL)
LDL cholesterol (mg/dL)
Triglycerides (mg/dL)
Activity monitor group (𝑛 = 14)
65.8 ± 6.7
78.6%
1.61 ± 0.08
62.4 ± 12.7
24.1 ± 4.0
6.6 ± 0.6
121.1 ± 10.8
67.8 ± 8.1
5.5 ± 1.6
66.6 ± 18.7
111.4 ± 34.9
107.6 ± 59.7
Pedometer group (𝑛 = 14)
62.4 ± 9.9
71.4%
1.63 ± 0.09
68.3 ± 9.5
25.9 ± 4.3
6.4 ± 0.9
121.6 ± 6.8
73.5 ± 9.0
5.6 ± 1.6
60.3 ± 11.6
103 ± 10.8
127.1 ± 90.8
𝑝 value
0.58
0.66
0.46
0.08
0.24
0.27
0.89
0.09
0.80
0.72
0.09
0.68
Values are mean ± SD.
BMI: body mass index; BP: blood pressure; UA: uric acid; HDL: high-density lipoprotein; LDL: low-density lipoprotein.
Therefore, this is possible not only by a physician but also
through instruction provided by other medical staff. This
demonstrates that the mere act of presenting exercise goals
to patients before using activity monitors and incorporating
moderate to high-level movement into their daily activities
seemed to contribute to the efficacy of exercise therapy.
The present study has certain limitations. The reduction
in HbA1c level at 6 months coincided with the summer
season (from the fourth month after the start of the study).
People tend to stay less outside for reasons such as to avoid
heatstroke. Due to potential reduced physical activity and
the effects of increased intake of glucose-rich sports drinks,
further studies of longer duration are needed, especially studies that take seasonal variations into consideration. Table 1
shows that the percentage of males was significantly higher
in the activity monitor group than in the pedometer group.
This could contribute to selection bias. For this reason, we
compared the extent of reduction in HbA1c at 2 and 6 months
between males and females and between patients with high
and low uric acid (Figure 5). We also analyzed background
characteristics and HbA1c changes in 28 patients who did
not change their medications during the 6-month period
(Table 2). Another limitation of the present study is that it
compared only the number of steps but not other parameters
that could be used to evaluate whether the use of activity
monitors actually increased the total amount of physical
activity (e.g., walking duration, walking distance, and total
calorie expenditure) in the two groups. Unfortunately, such
data could not be stored in the pedometer device.
The only available explanation for the continuation of
exercise by patients who did not achieve the exercise goals
was the second explanation of the pamphlet provided during
the consultation in the second month. However, it is difficult
to say that this is completely the same as instructions given
about exercise therapy in daily clinical consultation. Further
studies are needed to select the best follow-up regimen and
its relationship with the achievement of exercise targets in
patients with T2DM.
5. Conclusions
We have demonstrated in the present study the importance of
exercise therapy for patients with T2DM. The results showed
that awareness of the level of exercise intensity through the
use of an activity monitor that provides information about
exercise intensity, not a pedometer, improved HbA1c level
in the initial period of exercise. The results suggest that
the use of devices with functions that allow verification
of goal achievement in concrete terms contributes to the
continuation of exercise therapy among patients.
Competing Interests
The authors declare no competing interests regarding this
study.
Acknowledgments
The authors thank Wakana Miura and Mayumi Kuriyama
for their help in the completion of this study. This study
was sponsored by the Division of Nephrology, Endocrinology
and Metabolism, Department of Internal Medicine, Tokai
University School of Medicine, Japan (Grant no. 14F188139).
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