CLINICAL STUDIES
BioCoherence
and Lifewave Energy Enhancement Patches Utilizing Bionetic-Feedback Assessment
By Lee G. Woolley, CBT, BPA and Dr. Steven Haltiwanger MD.
BioCoherence Analysis (BCA) is
an emerging complex science that records and analyzes unique
bioelectrical information from
the body by measuring micro-voltage readings detected on the
skin’s surface. The
bioelectrical information is converted mathematically through specific
algorithms through FFT
analysis which specifically extracts meaningful information from within
the core data
isolated by specialized SsEMG equipment at specific and unique
bandwidths. The basic
filter for the tests and the measurements specifically isolated
frequency information data for this paper, were within the 0-10 Hz
range. The dynamic ranges (seven total) within that 0-10 Hz bandwidth were extracted by analyzing
known frequencies of the “standing waves” which are generated from cellular activity deep
within the body’s connective tissue matrix, and which are supported through Bionetic research
regarding specific data from the connective tissue or Tensegrity Matrix (Ingber), which
reflects specific energy flows and distribution of energy exchange within the organism. Such
transference is carried on in the 0-10 Hz range of the human
body constantly, representing
aspects of cerebral spinal fluid activity, neural plexus interfaces and
Bionetic data.
LifeWave LLC, developers of
the LifeWave Energy Patch (LEP) and NuVisions for Wellness,
developers of the
SpectraVision BCA Technology collaborated on measuring the effects of
the LEP in the
biomatrix. After analyzing over 1000 testing subjects in establishing
BioCoherence baselines
and then applying the LEP to the subject’s body, demonstrable shifts in
standing wave characteristics
have been noted. Changes in modulation, amplitudes, energy
distribution, and absorption
were all noted and initial findings showed significant changes in the
standing wave characteristics
of one or more aspects of BioCoherence. Overall these changes
demonstrated shifts
as increases in available energy potentials of ranges between 18 to 33%
over baseline data for ALL TEST SUBJECTS! Energy
distribution did support that the transfer of energy had both an
accumulative effect and that
some frequencies demonstrated a type of down regulation as other
frequencies had simultaneous
up regulation.
_______________________________________________________________________________________________________________________________________________________
Responsiveness
of Subjects to the LifeWave Patch during Aerobic and Muscular Endurance Activity.
Brianna L. Smith, Glaucio Scremin,
A.W. Faris, and Enrico EspositoESPOSITO
Twenty-six subjects were
recruited from the institution to participate in a double blind,
placebo controlled study of
the Lifewave Patch. None of the subjects had ever heard of or worn the
Lifewave Patch prior to this
study. Each of the subjects randomly selected an envelope, labeled with
an X or an O, containing either
the placebo or experimental patch before beginning the tests. Prior to
the study, the placebo and experimental
patches were divided and labeled without the test team’s knowledge to
ensure the integrity of the
study. Neither the test team nor the subjects had any indication of
which patch the subject had received.
Each subject participated in an
aerobic step test and muscular endurance push-up test. The step test
followed the procedures for the
YMCA three-minute step test (4). The subjects were provided a heart rate
(HR) monitor to measure HR
variances during each test. All subjects began the step test wearing no
patch and followed the test
protocol – stepping the height of 12-in. at a rate of 96 bpm - for
three minutes, then
immediately sat quietly on the
bench to recover. One minute following the completion of the test, the
HR was documented.
Following a recovery period of at least 10 minutes, the group of
subjects then performed an
untimed push-up test to exhaustion and repetitions were recorded. The
test team then positioned the preselected patches on the L1 meridian point (fig.
1) of each subject (7). The white patch was positioned on
the right and the tan patch was
positioned on the left side of the body. Although the findings of the aerobic
portion of this study are not significant, it is notable that the
experimental group saw an average
increase of 3% in average aerobic performance, while the placebo
group observed an average decrease
of 6.7% in performance. The difference in performance between the
experimental and placebo groups was
11.8%. Practically speaking, it is significant that although the
patches only helped to enhance the
performance of the experimental group by 3%, it illustrated an almost
12% increase over the placebo group
due to the decline in performance. In aerobic sports, a decrease in
heart rate will allow the athlete
to perform at a given workload longer. A decrease of 13 bpm, although
might not reveal a statistically
significant change, will positively affect the aerobic athlete allowing
them to fight the effects
of fatigue longer.
As with the aerobic portion of this
study, the push-up segment also demonstrated insignificant statistical
data. However, the experimental
group displayed a 9% increase in performance over the control repetitions, while the placebo group
showed a 10% decrease in performance. The difference in performance between the experimental and
placebo groups was 9%. As with the aerobic group, this data represents practical significance in
performance enhancement. It
is important to note that the statistical findings may be minor due to
the small subject sample size. The practical findings in this study
certainly warrant further research of the LifeWave patch on both
aerobic and muscular
endurance performance. Possibly with a larger subject pool significant
statistical data would support
the practical findings. Note
from Dr. Steve Haltiwanger- This is an early study on the LifeWave
patches. We have since determined
that at least 20 minutes of aerobic activity is needed to demonstrate
the increased production of ATP
from fat. This study did not have the participants exercise long
enough. We are repeating a study with
100 people with 20 minutes of
exercise on an exercise cycle.
______________________________________________________________________________________________________________________________________
A double blind placebo controlled study of the LifeWave technology as
it relates to the improvement of strength endurance
in high performance college athletics
By David Schmidt and Richard
Shaughnessy
The LifeWave technology is a new
supplement and method for the improvement of athletic performance.
LifeWave is a means by which an
individual may substantially increase their net strength endurance
within as quickly as the
first use of the product. To evaluate this statement in an unbiased
manner, a double blind placebo
controlled study was implemented at Troy State University in Troy,
Alabama. The principal investigator
of this study was Coach Richard Shaughnessy, strength and conditioning
coach for the Troy
State department of athletics. A
standardized test was selected to measure net gains in strength
endurance, and in this case
the exercise that was performed by all athletes was a 225 lb. flat
Bench Press. The baseline data
for this test was collected on Thursday June 26, 2003. The comparative
data was collected on the following
Wednesday July 2, 2003. Athletes were divided into three groups:
Control, Placebo and Test. The
Control group was tested “as is” on both of these testing days. The
Placebo group was given a set of patches filled with water; this group
was unaware as to whether or not the patches were real or water filled.
The Test group was given a set of
patches with the LifeWave technology; again, this group was unaware as
to the contents of the patches. It
will be emphasized that the athletes using the LifeWave technology used
the product only once; the test was
performed within 10 minutes of first applying the patches to the
athletes.
Based on the data collected and the
results obtained it was demonstrated that the LifeWave technology is a
method for the improvement of
athletic performance, and more particularly a means by which an
individual may increase
their net stamina/strength endurance output. The model utilized to
evaluate the technology was
a double-blind placebo controlled study, with 25 college athletes from
the Troy State University football
team volunteering to participate in this study. In this evaluation of
strength endurance involving competitive
athletes both baseline and comparative tests were performed prior to
any other type of physical activity.
Being that the athletes had a very brief usage of the LifeWave
technology, an additional study would prove to be of interest as a
comparison to this test study to determine what effect the LifeWave
technology has on athletes that
incorporate LifeWave into their daily training regime. It was demonstrated that the
Test/LifeWave group using the LifeWave technology showed the highest
percentage of improvement in
strength endurance when averaging all members, the highest percentage of
improvement in strength endurance
when averaging only those members who showed an improvement, and
the lowest percentage of decreased
performance when averaging only those individuals who showed a decline in performance.
______________________________________________________________________________________________________________________________________
LifeWave
Products, Pure Energy Patches 60-Subject Test
By Fenestra Research
LifeWave Patches are a non-invasive
dermal patch worn on the human body. Rotation of placement of these patches
was done on a daily base. This 6o- subject study was done without providing any
kind of information to the subjects about the intended outcome or scope of this study.
No educational material or advertisements were provided to the 60-subjects for the
length of this study.
Fenestra Research preformed human
Clinical Trials using this all-natural dermal patch system. This study involved
60-subjects of various , age, exercise levels, race, sex, and health levels. This study was
conducted for 30-days. Upon
commencement of this study each subject was provide the correct amount
of patches for their test
group number to be used in pairs for 30-days. Each daily
placement of the patches was done
in pairs on the body with the white patch being secured in place on the right side of
the body first and the tan patch placed on the left side of the body second.
Subjects were advised that no
changes to their daily lives should take place during this time. All subjects were instructed
to make no changes to their daily food consumption in regards to the amount or
the types of food they were consuming daily. No changes to the amount or type
of water should be done for the length of this study. Instruction relating to
water consumption were as follows; Each subject was to consume ½ of their weight in
ounces daily of what ever source of water they usually consumed. Upon completion of the 60-subject groups
30-day testing and intake these significant measurements were found:
1. An increase of 22.3% was
measured in the lipid side of the ATP cycle of energy production.
2. 30% of subjects reported an
increased since of well-being while wearing the patches.
3. Daily wear of the patches did
not have any reported negative side effects or interactions for the length of this
study.
4. At this time there are no
significant changes to any of the other Wellness measurements being tested.
5. Patches stayed in place all day
for each of the participants with the exception of use in ocean water. Patches stayed on
all day
through showers, sweating and daily activities.
6. No allergic reaction on or
around the area of placements were seen or reported during this study.
7. Five subjects reported a weight
loss of at least 6 pounds during this study.
8. 100% of these subjects tolerated
the patch test well.
We find that the daily use of the Energy Patches by LifeWave Products
did improve the energy
levels in 100% of our test subjects. This was proven using the Fenestra Research Labs Optimal
Wellness Test, described in attachments. The Energy Patches are 100% safe and
effective. Days of not wearing the patches were important to the overall usage and out
come of this study.
______________________________________________________________________________________________________________________________________
Heart
Rate Variability Signal Parameters Quantify Skin Cooling Effect of
Energy Patches During Rest and Exercise in Young Healthy Individuals
By Homer Nazeran PhD, CPEng
(Biomed.)
Heart
rate variability (HRV) signal analysis provides a non-invasive and
sensitive marker of autonomic nervous system (ANS) activity. Spectral
parameters of HRV signal are used to quantify the balance between
sympathetic and parasympathetic (sympathovagal) influences under
various physiologic conditions. ECG signals were acquired, filtered and
further processed to derive the HRV signal. The low frequency (LF),
high frequency (HF), and their ratio LF/HF were calculated to assess
the parasympathetic dominance or the skin cooling effect of a set of
non-transdermal Energy Patches on young healthy individuals during Rest
and immediately after mild Exercise. HRV data acquired from 20 young
healthy volunteers (10 males and 10 females, 19-25 years of age), in a
doubleblind placebo-controlled study, were used to evaluate the skin
cooling effect of these wearable devices on the ANS during rest and
immediately after mild exercise while wearing active (A) and placebo
(P) patches. Data from condition (A) and condition (P) were compared
using statistical analysis (one-sample inference). The LF/HF decreased
significantly both during rest and immediately after mild exercise in
condition (A) compared to condition (P) with ıor p <0.01 with a
statistical power of at least 85%. This study shows that the normalized
LF/HF derived from spectral analysis of HRV signals could be used to
quantify the parasympathetic dominance or the localized skin cooling
effect of non-transdermal energy patches during rest and immediately
after mild exercise in young healthy individuals.
The
autonomic nervous system (ANS) is structurally and functionally
subdivided into two antagonistic divisions: sympathetic and
parasympathetic. The sympathetic division responds to fight-or-flight
situations, increasing heart rate (HR) and blood pressure (BP), among
others, under stressful conditions. The parasympathetic division is
responsible for relaxation and energy conservation (i.e., decreasing HR
and BP). The heart as well as other organs, receives opposing
influences from these two arms of the ANS. This dual innervation
underpins a fine and continuous regulatory system and simply means an
increase in the activity of one division results in a smooth and
reciprocal decrease in the activity of the other. The dynamic interplay
between the two divisions increases or decreases the HR depending on
the predominance of one over the other. Heart Rate Variability (HRV)
signal refers to beat-to-beat variation of heart rate and represents
the cyclical changes in HR. As HR is modulated by both parasympathetic
and sympathetic inputs, HRV can be utilized as an indirect and
non-invasive marker of autonomic regulation and control under different
physiological conditions [1].
High
HRV reflects an ANS that is adaptable and dynamically responsive to
change whereas reduced HRV is indicative of an abnormal or restricted
ability of the ANS in maintaining homeostasis [2, 3]. Pharmacological
studies and spectral analysis of the HRV signal have revealed two clear
peaks in its power spectrum: a high frequency (HF) and a low frequency
(LF) component. The HF peak which is typically centered around 0.25 Hz
(0.15 – 0.4 Hz) arises 18 standard deviation of ± 49% of the mean. With
these values a statistical power of at least 85% at a significance
level a or p < 0.01 was achieved. This level of significance
reflects a very significant effect. As a value of a or p = 0.05 is
considered statistically significant, the results in these subjects
reflect a statistically significant effect with a power of 90%.
TABLE 1. Typical normalized power
spectral parameters derived from 5-minute HRV signals acquired
from ECGs of a healthy male
volunteer under 6 different conditions [16]
| Condition
|
LF n.u. |
HF n.u. |
LF/HF n.u. |
| Rest with no Patches |
97.70 |
2.28 |
42.75 |
| Rest with Placebo Patches |
97.62 |
2.31 |
42.23 |
| Rest with Energy Patches |
96.95 |
3.01 |
32.29 |
| |
|
|
|
| Exercise
with no Patches
|
97.42 |
2.56 |
38.03 |
| Exercise
with Placebo Patches
|
97.97 |
2.03 |
48.36 |
| Exercise
with Energy Patches
|
94.72 |
5.23 |
18.10 |
TABLE 2. Typical normalized power
spectral parameters derived from 5-minute HRV signals acquired
from ECGs of a healthy female volunteer
under 6 different conditions [16].
| Condition |
LF n.u. |
HF n.u. |
LF/HF n.u. |
| Rest with no Patches |
99.15
|
0.83
|
119.25
|
| Rest with Placebo Patches |
97.33
|
2.58
|
37.61
|
| Rest with Energy Patches |
94.20
|
5.37
|
17.54
|
| |
|
|
|
| Exercise with no Patches |
90.58
|
9.41
|
9.62
|
| Exercise with Placebo Patches |
96.40
|
3.54
|
27.23
|
| Exercise with Energy Patches |
95.32
|
4.62
|
20.63
|
Discussion and Conclusion
From the spectral parameters of
typical datasets and the statistical analysis results for 20 subjects,
the following
observations could be made:
- There
was a noticeable difference between spectral parameters when the
subjects wore the Placebo patches compared with when the subjects wore
no patches. Such differences in spectral parameters are indicative of
the Placebo Effect. This is an indication of how the subjects responded
to the feeling of wearing a patch.
- There
was a decrease in the normalized LF when the subjects wore the Energy
patches compared with the condition when the subjects wore the Placebo
patches during both Rest and immediately after 5 minutes of mild
Exercise.
- There
was an increase in the normalized HF when the subjects wore the Energy
patches compared with the condition when the subjects wore the Placebo
patches during both Rest and immediately after 5 minutes of mild
Exercise.
- There
was a statistically significant decrease in the normalized LF/HF when
the subjects wore the Energy patches compared with the condition when
the subjects wore the Placebo patches during both Rest and immediately
after 5 minutes of mild Exercise.
- On
average, female subjects were more responsive to Energy patches
compared to male subjects during Rest. While, on average male subjects
were more responsive to Energy patches compared to females after mild
Exercise. These differences were not statistically significant.
- On
average, there was a higher reduction in normalized LF/HF after 5
minutes of mild Exercise compared to the reduction in normalized LF/HF
during Rest.
Based on these observations it could be concluded that both during Rest
and immediately after 5 minutes of mild Exercise, the Energy patches
elicited an enhanced parasympathetic response (due to a localized skin
cooling effect) which could
be quantified by a reduction in normalized LF/HF. A further reduction
of normalized LF/HF immediately after 5 minutes of mild
Exercise (as a consequence of more body heat production) compared to
Rest may be indicative of
the higher activation level of the Energy patches in response to
enhanced physical activity resulting
in an increased localized skin cooling effect during Exercise. The
statistical results revealed that the Energy patches showed a very significant
effect (p < 0.01) compared to Placebo patches in reducing the
normalized LF/HF during
Rest and even further after 5 minutes of mild Exercise with a
statistical power of at least 85% in this sub-population.
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