Double Blind Placebo Crossover Human Clinical Study

 

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

 

July 13, 2015

 

Submitted by Energy Medicine Research Institute, Lisa Tully, PhD, founder

 

Abstract: A double blind placebo crossover human clinical study examined the efficacy of the Energy Armor Bracelet to increase flexibility, strength, balance and endurance in 16 healthy subjects. Results demonstrate that the Energy Armor Bracelet highly significantly increases performance (p<0.001) in all tests of flexibility, balance, strength and endurance except maximum bicep curls. The active bracelet outperformed placebo in 14 out of 16 tests (maximum bicep curl and peak watts). Furthermore, the Energy Armor Bracelet produce a four-fold increase over placebo in self-reported energy levels and 14 out of 16 of the participants identified the active bracelet at the end of the study. These results demonstrate the efficacy of the Energy Armor Bracelet in improving strength, flexibility, balance and endurance.

 

Introduction

The Energy Armor Bracelet (http://www.energy-armor.com) is a silicone bracelet imbedded with tourmaline, which is a natural source of negative ions. To date, over 5000 scientific studies have been conducted on the physiological effects of negative ions. Tourmaline is thought to have health benefits, including increased circulation, which may improve athletic performance. The Energy Armor Bracelet is designed to restore balance, enabling peak performance and a subsequent improvement in overall well being. There are no known contra-indications for the Energy Armor Bracelet.

A double blind placebo crossover clinical trial with 62 subjects conducted by Dr. Rashid Buttar (Center for Advanced Medicine and Clinical Research) reported that 72% showed improvements in the SF-36 Patient Outcome based questionnaire. In the current clinical study, tests were conducted that measure flexibility, strength and endurance in 16 healthy humans. 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 Energy Armor Bracelet improves performance in different tests of flexibility, strength and endurance in healthy humans.

 

Methods

Sixteen healthy individuals (8 male and 8 female) ranging from 24-54 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.

 

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 bracelet to be worn at the second testing.

Subjects were instructed to begin wearing the bracelet and continue wearing the bracelet for one week. They returned after one week (to allow recovery time) for retesting.   After the second testing, subjects were given the bracelet that was not tested at the second visit and asked to begin wearing the bracelet for one week, at which time they were retested.   The bracelets were coded so that neither the subject nor the person administering the tests knew which bracelet was being tested. Half of the subjects wore the placebo bracelets first and the other half wore the active bracelet first to prevent a “learning effect”. The subjects were instructed to refrain from strenuous exercise for 2 days prior to testing. Before each test, subjects were asked to rate their energy level on a scale of 1 to 10.

 

Flexibility Test                                                                                                                                                                      Subjects sat on the floor against a wall with feet against the stretch and reach measuring device (http://www.fitnessgiant.com/noname16.html) and reach as far forward as they can. 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 (http://www.topendsports.com/testing/store-strength.htm ) as hard as they can in each hand, 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.

  1. 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.                          
  2. 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.
  3. 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

  1. 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.

 

  1. 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.

 

  1. 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 Energy Armor Bracelet. As shown in Table 1, the active bracelet produced highly significant (p <0.001) increases from baseline for all outcome measures except maximum bicep curls. The energy level increase from baseline showed a trend towards significance.   Furthermore, 14 out of 16 of the participants identified the active bracelet at the end of the study.

 

Table 1. Summary statistics for absolute change from baseline for outcome measures with the active Energy Armor Bracelet.

 

                                             ACTIVE ENERGY ARMOR BRACELET

 

Parameter

Mean

     SD

Min

Max

p-value1

Stretch and Reach

0.23

0.19

-0.25

0.67

<0.001***

Balance

1.07

0.83

0.22

3.44

<0.001***

L Hand Strength

2.44

2.00

-3.00

6.00

<0.001***

R Hand Strength

3.06

2.21

0.00

8.00

<0.001***

Max Sit Ups

1.00

0.52

0.00

2.00

<0.001***

Max Push Ups

1.81

0.75

0.00

3.00

<0.001***

Max Bicep Curl

0.00

0.00

0.00

0.00

     0.999

Reps to Failure

1.50

1.03

0.00

3.00

<0.001***

Ave Speed

0.34

0.15

0.20

0.80

<0.001***

Peak Speed

0.39

0.16

0.20

0.70

<0.001***

Ave Watts

3.56

1.41

1.00

6.00

<0.001***

Peak Watts

3.69

1.35

1.00

6.00

<0.001***

Ave WPKG

0.12

0.04

0.10

0.20

   <0.001***

Peak WPKG

0.11

0.07

0.00

0.20

   <0.001***

Calories

3.38

0.96

2.00

6.00

<0.001***

Distance

0.04

0.01

0.02

0.06

<0.001***

Energy Level

0.38

0.81

-1.00

2.00

     0.083

 

1 p-value for evaluating changes from baseline within active group

2 p-value for comparison of changes from baseline between placebo bracelet vs. active bracelet

*     p<0.05

**   p<0.01

***   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 bracelet there was a decrease from baseline for maximum sit ups (-0.06). For all of the other tests with placebo, the minimum changes were either no change or negative (Table 2, Min column), whereas only two of the minimum changes with the active bracelet were negative (Table 1 Min column). A few of the increases with the placebo bracelet were significant (left hand strength, peak speed, peak watts, and distance, However, the active outperformed placebo in 14 out of 16 tests

 

The p-value2 column of Table 2 shows the comparison of changes produced by the active and placebo bracelets. As shown, there were highly significant (p<0.001) increases for the active bracelet compared to the placebo bracelet, except for maximum bicep curl and peak watts.  

 

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

 

                              PLACEBO ENERGY ARMOR BRACELET

 

Parameter

Mean

SD

Min

Max

p-value1

p-value2

Stretch and Reach

0.04

0.12

-0.33

0.17

0.186

   <0.001***

Balance

0.31

0.55

-0.71

1.80

0.042*

<0.001***

L Hand Strength

0.25

1.65

-4.00

4.00

0.554

<0.001***

R Hand Strength

0.38

1.46

-2.00

4.00

0.319

<0.001***

Max Sit Ups

-0.06

0.44

-1.00

1.00

0.581

<0.001***

Max Push Ups

0.25

0.93

-1.00

3.00

0.300

<0.001***

Max Bicep Curl

0.00

0.00

0.00

0.00

0.999

<0.001***

Reps to Failure

0.19

0.54

-1.00

1.00

0.188

   0.999

Ave Speed

0.09

0.06

0.00

0.20

<0.001***

<0.001***

Peak Speed

0.03

0.16

-0.20

0.40

0.460

<0.001***

Ave Watts

0.50

0.73

-1.00

2.00

0.015*

<0.001***

Peak Watts

1.56

4.60

-2.00

18.00

0.195

<0.001***

Ave WPKG

0.02

0.04

0.00

0.10

0.083

<0.001***

Peak WPKG

0.01

0.07

-0.10

0.10

0.718

<0.001***

Calories

0.81

0.40

0.00

1.00

<0.001

<0.001***

Distance

0.01

0.01

0.00

0.02

<0.001

<0.001***

Energy Level

-0.13

0.89

-1.00

2.00

0.581

<0.001***

1 p-value for evaluating changes from baseline within active group

2 p-vale for comparison of changes from baseline between placebo bracelet vs. active bracelet

*     p<0.05

**   p<0.01

**   p<0.001

 

Results for “carryover effect”, which occurs when learning occurs as a result of repeating the tests are shown in Table 3. In the comparison between active bracelet followed by placebo bracelet versus placebo bracelet there were slight differences between the treatment arms (whether the active or placebo bracelet was worn first), all tests showed no learning effect, except for reps to failure, average speed, peak speed and average WPKG.

 

Table 3. Analysis of learning effect with the Energy Armor Bracelet.

 

Outcome

p-value for carry-                   over effect

Stretch and Reach

0.799

Balance

0.057

L Hand Strength

0.143

R Hand Strength

0.346

Max Sit Ups

0.201

Max Push Ups

0.096

Max Bicep Curl

0.999

Reps to Failure

  0.002**

Ave Speed

0.030*

Peak Speed

0.027*

Ave Watts

0.632

Peak Watts

0.836

Ave WPKG

0.013*

Peak WPKG

0.120

Calories

0.096

Distance

0.794

 

 

*     p<0.05

**   p<0.01

 

Table 4 demonstrates that the groups were properly randomized. There were no significant differences at baseline detected between subjects who were randomized to the active-placebo sequence versus placebo-active sequence. except for stretch and reach and the p-value (p=0.046), was low.

 

Table 4. Comparison of outcome measures at baseline between subjects who were randomized to each Group

 

 

Placebo Bracelet first, Active Bracelet second (N=8)

Active Bracelet first, Placebo Bracelet second

(N=8)

Outcome Measure

Mean

SD

 

Min

 

Max

Mean

SD

 

Min

 

Max

p-value

Stretch and Reach

12.3

1.5

9.9

15.0

10.7

1.4

9.1

13.0

0.046*

Balance

10.0

6.9

2.3

22.7

6.4

3.1

3.1

10.7

0.205

L Hand Strength

70.9

11.9

54.0

89.0

61.0

21.7

37.0

96.0

0.277

R Hand Strength

72.0

20.1

43.0

96.0

69.8

23.4

38.0

110.0

0.839

Max Sit Ups

16.1

4.5

9.0

22.0

13.1

3.9

7.0

18.0

0.174

Max Push Ups

19.1

7.2

11.0

30.0

16.5

4.5

11.0

22.0

0.395

Max Bicep Curl

21.9

6.5

10.0

30.0

20.0

6.0

15.0

30.0

0.558

Reps to Failure

11.5

5.0

4.0

17.0

9.8

2.7

6.0

12.0

0.398

Ave Speed

15.1

2.3

12.2

18.4

13.3

1.8

10.2

15.2

0.101

Peak Speed

17.3

2.4

13.4

20.4

15.1

1.9

12.3

17.1

0.061

Average Watts

133.9

22.5

100.0

165.0

120.6

12.9

100.0

136.0

0.170

Peak Watts

153.6

26.6

117.0

194.0

140.5

17.6

110.0

167.0

0.264

Ave WPKG

1.4

0.4

0.9

2.0

1.3

0.2

1.1

1.6

0.717

Peak WPKG

1.8

0.4

1.2

2.4

1.7

0.2

1.3

2.1

0.617

Calories

23.3

3.9

19.0

29.0

22.6

3.6

19.0

28.0

0.745

Distance

1.2

0.2

1.0

1.5

1.1

0.1

0.9

1.3

0.378

Energy Level

6.1

2.0

3.0

9.0

6.4

   1.2

5.0

8.0

0.762

*     p<0.05

 

 

Flexibility Test

The Energy Armor Bracelet produced a highly significant increase in the stretch and reach measure (Table 1, p=0.001. The change produced by the placebo bracelet was not significantly different from baseline (Table 2, p=0.0.186). The active bracelet outperformed placebo by over 3.5-fold and there was a highly significant difference between the active and placebo bracelets (Table 1, p<0.001).

 

Balance Test

The length of time balancing on one foot with eyes closed and arms outstretched was highly significantly increased by the active bracelet (Table 1, p=0.001. There was a highly significant increase in performance of the active bracelet over the placebo bracelet (p=0.001).

 

Strength Tests

As seen in Table 1, the Active Energy Armor Bracelet produced highly significant (p<0.001) increases from baseline for all strength outcome measures (left and right hand strength, peak speed and watts, peak WPKG and calories) except maximum bicep curls. For this test, there was no change from baseline for the for either the active or placebo bracelet. With the placebo bracelet, there was a low p-value (level of significance) for increases from baseline for peak speed and calories (Table 2, p-value1 column). However, there was a highly significant (p<0.001) difference between active and placebo for all strength tests (Table 2, p-value2 column) except maximum bicep curls,

 

Endurance Tests

Table 1 shows that there was a highly significant (p<0.001) increase from baseline for all of the endurance measures with the active bracelet (maximum sit ups and push ups, bicep curl reps to failure, average speed, average watts, average WPKG and distance), . In contrast, a decrease in performance with the placebo bracelet was observed with maximum sit ups (-0.06), With the placebo bracelet, there was a low p-value (level of significance) for increases from baseline for average speed and calories (Table 2, p-value1 column). However, there was a highly significant (p<0.001) difference between active and placebo for all endurance tests (Table 2, p-value2 column) except peak watts, which showed a trend towards significance.

Energy Levels

The active bracelet demonstrated a trend towards significance (p=0.38) for self-reported energy levels. The active bracelet produced an increase of 0.81, whereas the placebo produced a decrease (-0.13) and there was a highly significant difference between active and placebo (p=0.002).

 

Fourteen out of the 16 participants correctly identified the active bracelet, 2 of the total did not know which bracelet was active and no one thought the placebo was the active bracelet.

 

Discussion

Results of this double blind crossover pilot study demonstrate that the Energy Armor Bracelet produces a highly significant increase in performance for 15 out of 16 of the tests of flexibility, strength, endurance left and that were conducted (stretch and reach, balance, right hand strength, bicep curl 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) except bicep curl maximum weight. This high level of significance demonstrates improvement in athletic performance with the Energy Armor Bracelet. Results demonstrated an increase of nearly 80% in some subjects and the average was an increase of nearly 20%.

 

In contrast, the placebo bracelet produced decreases in two of the outcome measures. It is not certain why the placebo bracelet produced a significant increase in four of the tests, although the p-values were substantially lower for placebo than active. Furthermore, there was a highly significant difference between the active and placebo bracelets in all tests of strength, balance, flexibility and endurance except peal watts and maximum bicep curl test.

 

In a self-report of energy levels, the active Energy Armor Bracelet outperformed placebo four-fold and this was highly significant. Furthermore, 14 out of 16 participants identified which bracelet was the active one. These results indicate that there is a noticeable increase in energy and performance with the Energy Armor Bracelet.

 

Although the absolute changes seem small for 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 observed with the active Energy Armor Bracelet had a high level of significance, demonstrating the efficacy of the Energy Armor Bracelet in the tests.

 

Factors that can influence 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 a slight “learning effect” (that can occur as a result of repeating a test, regardless of the length of the washout period), except for except for reps to failure, average speed, peak speed and average WPKG. However, the groups were divided and half did each bracelet first to avoid learning effect.

 

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 performance.  

 

Conclusions

This double blind crossover clinical trial shows that the Energy Armor Bracelet produces a highly significant increase in 15 out of 16 tests of flexibility, balance, strength and endurance in 16 healthy humans when worn for one week. Results demonstrated an increase of nearly 80% in some subjects and the average was an increase of nearly 20%. Furthermore, the Energy Armor Bracelet outperforms placebo in 14 out of 16 outcome measures.   This result is correlated with a reported increase in energy levels . Participants wearing the active bracelet reported nearly a 4-fold increase in energy levels over placebo. Importantly, 14 out of 16 participants identified the active band. These results demonstrate the efficacy of the Energy Armor Bracelet in improving strength, flexibility, balance and endurance. It is likely that the Energy Armor Bracelet will produce greater or sustained effects when worn for longer periods.

 

Research Team

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

 

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 vibrational medicine technologies and therapies.  

 

Ryan Shilling, owner of Watts Up, a company that specializes in athletic training, has professionally tested athletes for a decade.  He has performed testing for Athletic Republic, a company that trains athletes.  He has conducted field tests on athletes specific to running and cycling.  He specializes in testing athletes for strength, flexibility and endurance for training purposes.