Report for Double Blind Placebo Crossover Human Clinical Study of the Efficacy of the Ionic Balance Band in Improving Flexibility, Strength, Balance and Endurance in Healthy Subjects

November 21, 2012

Submitted by Energy Medicine Research Institute
www.energymedicineri.com
Lisa Tully, PhD, Founder

Abstract

A human clinical study examined the efficacy of the Ionic Balance Band to increase flexibility, strength, balance and endurance in 16 healthy subjects. Results demonstrate that the Ionic Balance Band significantly increases performance (up to 92%) in every test of flexibility, balance, strength and endurance that was conducted. In addition, over a 20% increase in energy was reported.

Preface

"We commissioned Dr. Tully and her team to quantify in real terms some of the physical benefits and to legitamise our specific product - the Ionic Balance Band. We opted for this Crossover trial in which all test subjects wore both Active and Placebo bands to prove beyond doubt the efficacy of our Bands. This exploratory pilot study was conducted to discover the feasibility of a second, more in depth study which will be measuring additional parameters." Calum Liptrot - Ionic Balance CEO

Introduction

The Ionic Balance Band (http://www.ionic-balance.com/) is a medical grade silicone band to which a proprietry formula is added. This formula is unique to Ionic Balance as is this study. Results for this study are specific to the Ionic Balance Band and it's unique patented formula and should not be construed as proof of efficacy for any other product.

All Ionic Balance products are CE marked (European Commission) and comply with all European health, safety and environmental protection legislation. There are no known contra-indications for the Ionic Balance Band.

The premise of the Ionic Balance Band is to emit Negative Ions (anions), Far Infrared Rays and Alpha Waves. This is achieved by the proprietary formula which is added during the manufacturing process. These properties are then absorbed by the wearer.

This Double Blind Crossover Placebo Controlled Study assessed the efficacy of the Ionic Balance Band in improving flexibility, strength, balance and endurance in 16 healthy subjects.

In this clinical study, the tests conducted included: stretch and reach, hand strength, maximum sit ups in 30 seconds, maximum push ups in 30 seconds, maximum bicep curl weight, maximum bicep curl repetitions and outcome measures with an ergometer bicycle (peak and average power and watts per kilogram, average and peak speed and speed per kilogram, distance and calories. These results demonstrate that the Ionic Balance Band improves performance in several different tests of flexibility, strength and endurance in healthy humans.

Methods

Sixteen healthy individuals (11 male and 5 female) ranging from 20-57 years of age with no history of disease, pregnancy, drug or alcohol use, or on any medications were subjects in this study. All subjects were in good general health and did not have a high level of fitness. Male/female ratio was based on the customer demographics provided by Ionic Balance.

Institutional Review Board approval was obtained for this study. A baseline measurement was conducted utilizing flexibility and balance tests and ten different strength and endurance tests, described below. At the baseline testing, subjects were given either the active or placebo band to be worn at the second testing.

Subjects were instructed to begin wearing the band and continue wearing the band for one week. They returned after one week (to allow recovery time) for retesting. After the second testing, subjects were given the band that was not tested at the second visit and asked to begin wearing the band for one week, at which time they were retested. The bands were coded so that neither the subject nor the person administering the tests knew which bands was being tested. Half of the subjects wore the placebo bands first and the other half wore the active band first to prevent a “learning effect”. The subjects were instructed to refrain from strenuous exercise for 2 days prior to testing.

Flexibility Test

Subjects sat on the floor against a wall with feet against the stretch and reach measuring device (AcuFlex Sit & Reach) and reached as far forward as they could. The distance reached was measured three times and the highest value recorded

Balance Test

Participants stood on one foot with eyes closed and arms outstretched. They touched their nose with each index finger. The length of time until their other foot touched the floor was recorded.

Strength Tests

A) Digital Hydraulic Hand Grip Dynamometer

Subjects squeezed the hand grip dynamometer as hard as they can in each hand. They tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer was adjusted if required - the base should rest on first metacarpal (heel of palm), while the handle should rest on middle of four fingers. The subject squeezed the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort. Two measurements with each hand were recorded and the highest score was recorded.

B) One Repetition Maximum Test to Measure Maximum Strength of the Bicep.

Bicep Curl maximum weight was determined by having the subject perform a bicep curl with a five pound free weight using the dominant arm. The weight was increased by five pounds until the subject could no longer lift the weight with proper form. If the subject was unable to lift the weight, 2.5 pound weights were used as increments to determine the maximum weight that can be lifted and this weight was recorded.

C) Maximum Sit Ups and Push Ups in 30 Seconds

Subjects did as many sit ups as they could in 30 seconds with their feet held down and knees bent. The number was recorded. This was repeated after a 5 minute rest with push ups, either leaning against the wall, on knees or on toes. The same posture was used for all tests and the maximum number performed in 30 seconds was recorded.

D) Five Minute Road Course Ergomometer Measurements: Peak Speed. Watts and Peak Speed and Watts per Kilogram

Subjects were asked to pedal on a stationary bike with an ergomometer at their peak performance for five minutes. Peak speed and watts and peak speed and watts per kilogram were recorded.

Endurance

A) Bicep Curl Repetition to Failure

This test was done last to allow recovery time. The dominant arm was used to curl 70% of the maximum weight to failure and this number was recorded.

B) Maximum Sit Ups and Push Ups in 30 Seconds

Subjects did as many sit ups as they could in 30 seconds with their feet held down and knees bent. The number was recorded. This was repeated after a 5 minute rest with push ups, either leaning against the wall, on knees or on toes. The same posture was used for all tests and the maximum number performed in 30 seconds was recorded.

C) Five Minute Road Course Ergomometer Measurements: Average Speed and Watts. Average Speed and Watts per Kilogram, Calories and Distance

Subjects were asked to pedal on a stationary bike at their peak performance for five minutes. Distance, average speed, calories and peak watts per kilogram were recorded.

Statistical Methods

Descriptive statistics were generated to summarize clinical outcomes. Specifically, all outcome measures were summarized in terms of number of means, standard deviations, and ranges (minimum, maximum), stratified by group (placebo vs. active). Absolute changes from baseline were computed for all outcome variables. A paired t-test was used to evaluate changes from baseline within each group. The comparison of changes from baseline between groups was performed using the Grizzle model for cross over studies. A p values are two-tailed and P < 0.05 indicates statistical significant differences. Data analysis was performed using SAS® version 9.2 software (SAS Corp., Cary, NC). The Grizzle model for 2 X 2 cross over study design was used to evaluate the carry over or learning effect.

Results

Table 1 shows the results for absolute change from baseline for all outcome measures of those wearing the active Ionic Balance Band. As shown in Table 1, the active Ionic Balance Band produced positive absolute changes from baseline values for all outcome measures and the p-value1 column shows that all of these changes were highly significant (p<001) for every measure except balance (p=0.008) and bicep curl repetitions to failure (p=0.002).

The p-value2 column of Table 1 shows the comparison of changes produced by the active and placebo bands. As shown, there were highly significant (p<0.001) increases for the active band compared to the placebo band for all outcome measures except right hand strength (p=0.249).

Table 1. Summary statistics for change from baseline for outcome measures

1 p-value for evaluating changes from baseline within active group
2 p-value for comparison of changes from baseline between placebo band vs. active band
* p<0.05
** p<0.001

Definition of statistical term in tables:

Mean=average values for all subjects
SD - Standard Deviation, how much the data varies from the mean (average of all the data)
Min - minimum or lowest value
Max - maximum or highest value
p-value - the probability that the data is different than the comparison (baseline or placebo) value. A p-value of less that 0.05 indicates that the data is significantly different from the comparison measure. The lower the p-value, the more different the test value is from the comparison test value.

In contrast, Table 2 shows that for the placebo band there were decreases from baseline for eight of the performance measures (left hand strength, maximum sit ups and push ups, bicep curl repetitions to failure, average watts, average and peak watts per kilogram and calories) and no change for maximum bicep curls and distance. Only one of the tests demonstrated a significantly different increase from baseline. There was a significant increase from baseline for the balance test, with a mean value of 2.29 seconds (p=0.02).

Table 2. Summary statistics for change from baseline for outcome measures with the placebo band

1 p-value for evaluating changes from baseline within active group
2 p-value for comparison of changes from baseline between placebo band vs. active band
* p<0.05
** p<0.001

Table 3 shows results for all outcome measures when expressed as percent change from baseline. The active band produced a positive percentage increase for every outcome measure, with the mean value for each outcome measure ranging from 6% to 92%. The average percentage increase for all measures was 18.69%. Furthermore, there was a highly significant difference between active and placebo bands for every measure (p=0.001) except balance (p=0.056), which had a lower significance level.

The p-value2 column of Table 3 shows the comparison of changes produced by the active and placebo bands. As shown, there were highly significant (p<0.001) increases for the active band compared to the placebo band for all outcome measures except right hand strength (p=0.630). Balance and average speed had lower significance levels for this comparison.

Table 3. Summary statistics for percentage change from baseline for outcome measures with the active band

1 p-value for evaluating changes from baseline within each group
2 p-value for comparison of changes from baseline between placebo vs. active band
* p<0.05
** p<0.001

Results for the placebo band are shown in Table 4. In contrast to the active band, the placebo band produced negative changes from baseline for eight of the outcome measures: left hand strength (-1.87%), maximum sit ups (-0.38%), maximum push ups (-0.22%), maximum bicep curl (-0.78%), peak speed (-5.44%), peak watts (-0.5%), average watts per kilogram (-0.45%) and calories (-0.12%). None of the percent increases from baseline were significant.

The comparison of the difference between active and placebo bands is shown in the p-value2 column. All of the outcome measures were highly significantly different between active and placebo except right hand strength (p=0.63).

Table 4. Summary statistics for percentage change from baseline for outcome measures with the placebo band

1 p-value for evaluating changes from baseline within each group
2 p-value for comparison of changes from baseline between placebo vs. active band
* p<0.05
** p<0.001
*** p<0.0001

Flexibility Test

The Ionic Balance Band increased the stretch and reach measure by a 12.44% inches (Table 3, p=0.001), a highly significant improvement. The change produced by the placebo band was a 0.23 % increase and not significantly different from baseline (Table 4, p=0.663). There was a highly significant difference between the active and placebo bands (Table 1, p=0.001).

Balance Test

The length of time balancing on one foot with eyes closed and arms outstretched increased by 92% (Table 2, p=0.05) for the active band, compared to an increase of 35% for the placebo band (Table 4, p=.096), which was not significant. There was a significant difference between the active and placebo bands (p=0.001).

Strength Tests

As seen in Table 3, all of the strength tests resulted in highly significant percentage increases with the active Ionic Balance Band compared to the placebo band, except right hand strength (p=0.63). The increase in left hand strength, peak speed, peak power and peak watts per kilogram with the Ionic Balance Band were highly significant (p<0.001).

Endurance Tests

Table 3 shows that there was a highly significant increase from baseline for all of the endurance measures (maximum sit ups in 30 seconds, maximum push ups in 30 seconds, average speed and watts. average speed and watts per kilogram, calories and distance (p=0.001). There was a highly significant (p<0.001) increase from baseline between the active and placebo bands.

Energy levels

Table 1 shows energy levels rated on a scale of one to ten. Before each test, subjects were asked to rate their energy levels on a scale of one to ten. The average baseline measures for both active and placebo bands were 7 and the average energy levels for the active band was increased by 21.39% to 8.06 , whereas the reported energy level was decreased to 6.94.

Table 1. Energy Levels Absolute Change from Baseline on a Scale of 1 to 10

Learning Effect and Proper Randomisation of Groups

There is no evidence for “carryover effect”, which occurs when learning occurs as a result of repeating the tests. The summary statistics for all outcome measures for the group that wore the placebo band first are shown Table 5. The summary statistics for the group that wore the active band first are given in Table 6. There is no significant difference in the comparison between active band followed by placebo band versus placebo band followed by active band, demonstrating that there was no learning effect from repeating the measures. The p-values for the comparison for carryover effect are given in the p-value1 column of Table 6. As shown in the p-value1 column, there were no significant differences in outcome measures resulting from the order of band.

Table 5. Summary statistics for outcome measures in the placebo first treatment group

Table 6. Summary statistics for outcome measures in the active first treatment group

1 p-value for evaluating carry-over effect (active band followed by placebo band versus placebo band followed by active band)

Table 7 shows that there were no differences between baseline measures for active and placebo groups, demonstrating that the groups were properly randomized.

Table 7. Comparison of outcome measures at baseline between subjects who were randomized to the Active-Placebo sequence vs. Placebo-Active sequence

Discussion

Results of this double blind crossover pilot study demonstrate that the Ionic Balance Band produces a significant increase in performance for all of the tests of flexibility, strength and endurance that were conducted (stretch and reach, left and right hand strength, bicep curl maximum repetitions to failure, maximum sit ups in 30 seconds, maximum push ups in 30 seconds, maximum peak and average speed, peak and average watts, peak and average watts per kilogram, and distance). There was a high level of significance for all of the outcome measures, indicating a dramatic improvement in athletic performance.

Conversely, the placebo band produced decreases in half of the outcome measures, no change in bicep curl maximum weight and did not produce any significant increase for most of the remaining outcome measures. There was a placebo effect for only the balance and left hand strength tests. However, there was a significant increase with both the active and placebo bands and there was a significant difference between active and placebo bands indicating that the active band increased performance compared to the placebo band.

Although the absolute changes seem small for some of these tests, they are significant changes, especially when one takes into account the importance of lifting a weight that is only a few pounds heavier. The same conclusion is true for the stretch and reach test, using distance as the endpoint rather than weight lifted. Furthermore, the increases obeserved with the active Ionic Balance Band had a high level of significance, demonstating the efficacy of the Ionic Balance Band in the tests.

When expressed as percentage increase from baseline, the mean increase ranged from 6 to 92% for all outcome measures. The average percentage increase for all outcome measures produced by the active band was 18.69%. In contrast, the placebo produced a decrease in performance in over half the tests and the average percentage increase for all of the tests was 3.69%. The variability for both active and placebo for the right hand strength test was higher for the placebo group than all of the other outcome measures, which could explain the lack of significance between active and placebo bands.

A very important finding is that a more than 20% increase in energy levels was reported with the active band and there was very little change with placebo band. The increase in energy felt by the participants can improve performance both psychologically and physically.

Factors that can infuence the outcome were analyzed and found to have no effects on the outcomes. All of the subjects were properly randomized, as shown by the lack of difference between baseline measures between the active and placebo groups. Additionally, there was no “learning effect” (that can occur as a result of repeating a test, regardless of the length of the washout period).

The tests utilized in this pilot study are objective measures of flexibility, balance, strength and endurance that are used in standard athletic testing. They are academically credible and superior to applied kinesiology tests that are commonly used to demonstrate the efficacy of products that increase athletic performance.

Conclusions

This double blind crossover clinical trial shows that the Ionic Balance Band produces a significant increase in all tests of flexibility, balance, strength and endurance in 16 healthy humans when worn for one week. The average percentage increase for all of the tests was 18.69%. Furthermore, there was a significant difference between active and placebo bands in performance, demonstrating that the Ionic Balance Band increases performance above placebo controls. It is likely that the Ionic Balance Band will produce greater or sustained effects when worn for longer periods.

Furthermore, a more than 20% increase in energy levels with the Ionic Balance Band was reported in this study. This result has relevance for both athletes and non-athletes.

Research Team

Research was conducted by Lisa Tully, PhD, founder of the Energy Medicine Research Institute and Ryan Shilling, owner of Watts Up. Both companies are based in Boulder, Colorado, USA.

Dr. Lisa Tully received her PhD in Pharmacology and Toxicology from the Indiana University School of Medicine. Dr. Tully has several publications in peer-reviewed medical journals and has presented her research at international scientific conferences. Following her postdoctoral fellowship, Dr. Tully shifted from academic medical research to pursuits in integrative medicine and has attended many international medical conferences over the past decade, evaluating low cost and effective health care.

Dr. Tully is currently on the Scientific Advisory Board of several companies and non-profit organizations and is founder of the Energy Medicine Research Institute, whose mission is to assess the efficacy of alternative medicine technologies and therapies.

Ryan Shilling, owner of Watts Up, a company that specializes in athletic training, has professionally tested athletes for over a decade. He has performed testing for Athletic Republic, the worldwide leader in science based performance sports training. He has conducted field tests on athletes specific to running and cycling. He specialises in testing athletes for strength, flexibility and endurance for training purposes.

Glossary of Terms

Proprietary - manufactured and sold only by the owner of the patent, formula, brand name, or trademark associated with the product.

Pilot Study - A pilot study, is a small scale preliminary study conducted before the main research in order to check the feasibility or to improve the design of the research. They are frequently carried out before large-scale quantitative research in an attempt to avoid time and money being wasted on an inadequately designed project. A pilot study is usually carried out on members of the relevant population, but not on those who will form part of the final sample. This is because it may influence the later behavior of research subjects if they have already been involved in the research. A pilot is often used to test the design of the full-scale experiment. The design can then be adjusted in time. This can turn out to be valuable: should anything be missing in the pilot, it can be added to the experiment and chances are, the full-scale (and more expensive) experiment will not have to be re-done.

Exploratory Study - An exploratory study is undertaken when not much is known about the situation at hand or no information is available on how similar problem or research issues have been solved in the past. In such cases, extensive preliminary work needs to be done to gain familiarity with the phenomenon in the situation and understand what is occurring before we develop a model and set up a rigorous design for comprehensive investigation. In essence exploratory studies are undertaken to better comprehend the nature of the problem since very few studies might have been considered in that area. Extensive interviews with many people might have be undertaken to get a handle on the situation and understand the phenomena. More rigorous research could then proceed. Exploratory studies are also necessary when some facts are known but more information is needed for developing a viable framework.

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