Scientific Research

In this document, we describe the effects of our device, which is basically a weighted belt, and a stylish designer belt to replace any normal belt.

The belt component has a variable weight of approximately six to twelve pounds, depending on the length of the belt (size of the user). We designed it such that most of the weight of the belt is distributed about the level of the iliac crests. The weights add to gravitational forces compressing the hips, legs and pelvis.

Whenever one is wearing the belt, as long as the user is not sitting, one will automatically be forced to perform weight-bearing exercise. The extra weight increases resistance during normal activities and forces the leg, buttock, abdominal and trunk muscles and therefore the heart to work a more little than normal to perform every movement.

So, below we have compiled what the research community has to say about the benefits of wearing this device, which equate to the benefits of weight bearing exercise. Let us assume that the user is wearing about 8 pounds. The benefits then, are a result of the mechanics of weight bearing exercise, and hopefully, if we can encourage users to maximize the time, sustained weight-bearing exercise. One can tabulate the effects of the device as follows:

  • Downward pressure on the skeleton, including the neck of the femur, the location of greatest health concern for osteoporosis prevention
  • Making the leg and trunk muscles, and hence the heart work a little harder to accomplish normal daily activities of living.
  • The longer one wears the weighted belt, the greater the physiological benefits that accrue to the wearer

The benefits likely to accrue from the continued use of our device would be as follows:

  • The potential for strengthening bones by causing them to increase bone mineral density. This would help to prevent hip fractures and the falls that result in $Billions per year in the consequent hospitalization and deaths of many of the victims.
  • Since the muscles are working a little harder all the time, the device has the potential to help to increase leg and trunk muscle tone, strength and endurance, thereby improving stability & preventing falls. The demands of the muscles will cause the heart and lungs to increase oxygen delivery therefore working a little harder thus increasing cardiovascularity and reducing the risk of heart disease. This device therefore has the potential to cause both aerobic and resistance exercise to be performed by the user.
  • The extra effort put forth by the muscles results in burning calories, weight control, and increasing cardiovascular strength.
  • The extra effort put out to perform one's activities of daily living may have the potential to enhance stamina and general fitness overall. This in turn may help one to one feel reduced stress, tension & fatigue.
  • In general, the above amounts to a better quality of life for those that will use this item.

Our goal is to provide an attractive article of clothing / device to be used for as many hours per week as possible, by making it a convenient lifestyle choice. The current research refers to studies on weight bearing resistance exercise for just a few a few hours per week. We believe that all the benefits reported would be further enhanced by extending the number of hours devoted to this activity. Therefore we are planning to encourage users of our product to do their best to use it for as many hours as is practical according to their individual lifestyles. The design enables users, if they need to, to begin wearing the belt for a short daily period, say one-half to one hour, and gradually increase the time worn in increments until they reach their personal maximum. This makes it possible for an individual to "ramp up" their usage so as to minimize irritation to knees, ankles, and feet. This also allows a user with osteoporosis the opportunity to experience a slight increase in weight bearing and slowly build bone mass over time, when it may become possible to increase the wearing time. Individuals are counseled to seek medical advice to determine whether what levels of weight and time their personal bone mineral density can safely handle.

Below, we will show references for each of the benefits claimed above. These references are by no means exhaustive, as we found it necessary to omit many articles due to the volume of research performed in these areas to date. Also, many of the quoted sources refer to more than one of the benefits listed above.

Our primary strategy is to persuade the users of our device to maximize the amount of time they are performing weight-bearing exercise. The benefits of weight-bearing exercise are well documented and widely known. This is a low-tech approach to improved health that we hope to make widely available to the general public, with the approval of Health Canada. The ability to associate those benefits with our product would be a great encouragement for people to obtain a tool for health improvement as well as problem prevention. If this device becomes widely used, the potential savings in health care costs to the general public could be huge.

Research

Weight-bearing or mechanical stress alone has been shown to relate to increased bone mineral density(1). Radiologists confirmed Wolff's Law (bones respond to the loads placed upon them by increasing in strength) in the early 20th century, when it was noticed that individuals who experienced a gain in weight also experienced a gain in bone calcification.

The weight bearing status of exercise has been shown to be the most likely factor influencing the effectiveness of exercise in developing bone mass. Among exercisers, increased bone mineral density (BMD) has appeared among those performing weight-bearing exercise, while those performing exercise without weight bearing did not(2). In general, active women and athletes have higher bone mineral densities than sedentary women. Swimmers, however, are an exception to this generalization. It has been found that swimmers have similar or even lower bone mineral densities than sedentary women(6,7). It has been hypothesized that these differences occur because swimmers are not participating in a weight bearing activity and because they experience periods of weightlessness(7).

Researchers have proposed the possibility that maximizing one's bone mineral density will help prevent osteoporosis. The idea behind this proposal is that by attaining a very high BMD, it will take many more years for a woman undergoing post-menopausal bone changes to reach an osteoporotic state. While this idea is only a theory, it is the basis of the osteoporosis prevention literature that focuses on ways to increase peak bone mass(3).

While bone mineral loss is apparent in post-menopausal women, research has shown that low to moderate intensity exercise can help increase bone mineral density in pre-menopausal women. Women who participated in a low to moderate intensity exercise regimen had higher bone mineral densities than women who were not exercising regularly(4). Of the 93 pre-menopausal, eumenorrheic women in this study, 34 participated in aerobic dance classes, 28 walked and 31 served as sedentary controls. While both groups of exercising women had significantly higher bone mineral densities than the sedentary controls, no significant differences were found in the bone mineral densities between the subjects who walked and those who took aerobics classes. These results indicate that participation in low to moderate, weight bearing activities can have a favorable effect on BMD.

While non-weight bearing activities like swimming do not increase and may even decrease bone density, research has shown that various forms of weight bearing activity increase bone density(4). Alekel et al. (1995) studied the effects of walking and aerobic dancing on BMD in pre-menopausal women ages 25-41. These women had no history of amenorrhea or of participation in competitive athletics. Each participant reported participating in either aerobics classes or walking for 45 minute sessions, three to seven times a week, for at least one year. The sedentary controls had not participated in any regular form of physical activity in the past year. It was found that the women who walked or participated in aerobics classes had significantly greater proximal femur, lumbar spine and femoral neck BMD than the sedentary controls. No differences were found, however, in any of the BMD measurements between the walkers and the aerobic dancers. According to these findings, both walking (exercise) and aerobic dancing promote similar increases in bone density.

Since lifting weights provides weight bearing exercise on the entire skeleton, it is not surprising that body builders tend to have higher bone mineral densities at all sites(6,7,8). It appears that low to moderate, weight bearing exercise is a good guideline for exercising to promote maximal increases in bone mineral density(3,5,6,8). While no guidelines have been established, increases have been found with women walking or doing aerobics in 45 minute sessions, three to seven times a week(4).

Most of the above research relates to the effects in pre-menopausal women. There is evidence of a linear relationship between BMD change and total and exercise-specific weight lifted in a 1-yr strength-training program, reinforcing the positive association between this type of exercise and BMD in postmenopausal women(9).

The BEST (Bone, Estrogen, Strength Training) research study at the University of Arizona was designed to evaluate the effectiveness of exercise on bone and cardiovascular health in postmenopausal women(10). Weight bearing and exercise appear to be synergistic with hormone replacement therapy (HRT) for increasing BMD. Their conclusions are quoted directly:

  1. The combination of HRT, exercise, and calcium intake increased bone mineral density the most.
  2. Those who lifted more weight had the most gains in bone - especially at the hip location
  3. The exercise program had less effect on bone for those who lost 5 lbs or more of body weight, as compared to those who did not lose weight or those who gained weight.
  4. The exercise program had less effect on bone for those who had higher scores of depression at the beginning of the study.
  5. Large increases in body strength were found for all subjects who participated in the exercise program. Increases were also found in body image, self-concept, and quality of life.

This research is important because we found that consistent weight lifting and weight-bearing exercise with HRT and calcium citrate supplementation has an advantage over other combinations. In addition, if participants continue to follow this comprehensive program for several years, further benefits to fracture risk may be obtained in post-menopausal women.

The American College of Sports Medicine published a position paper(11) in 2000 on exercise and type 2 diabetes. They state that physical activity, including appropriate endurance and resistance training, is a major therapeutic modality for type 2 diabetes(11). Resistance training has the potential to improve muscle strength and endurance, enhance flexibility and body composition, decrease risk factors for cardiovascular disease, and result in improved glucose tolerance and insulin sensitivity. This is not limited to diabetic patients, however this statement refers to applying the general benefits of resistance training to diabetics.

Morris & Hardman(12) describe the multifarious benefits of walking with minimal adverse effects, especially when performed at over 70% of maximal heart rate. They report that it develops and sustains physical fitness, cardiovascular capacity and endurance (stamina), strengthening of the muscles of the legs, pelvis and trunk, enhances the metabolism of HDL's and insulin/glucose dynamics. They cite "growing evidence of gains in the prevention of heart attack and reduction of total death rates, in the treatment of hypertension, intermittent claudication and musculoskeletal disorders, and in rehabilitation after heart attack and in chronic respiratory disease". Shangold(13) reports that aerobic resistance exercise may prevent or relieve depression in post-menopausal women as well as cardiovascular disease, obesity, muscle weakness, and osteoporosis.

Singh (see Appendix: "Exercise as a Long Term Anti-Depressant in the Elderly") explored weight lifting as a possible treatment for clinical depression and concludes that it is an effective, safe and feasible antidepressant.

As for the effects of weight bearing exercise on young people, please consider the following: Children as young as 7-8 years old can significantly increase bone mass through a brief, specific exercise regimen. This may help them "bank" extra bone to prevent osteoporosis when they are much older, according to a study at Oregon State University (see "Banking Against Osteoporosis" - Appendix).

One of our objectives is to improve stability in the elderly to prevent falls. Ades et al (see "Weight Training Improves Walking Endurance in Healthy Elderly Persons" in Appendix) found increases in leg strength and walking endurance in men and women over age 65 when resisted aerobic exercise was performed for 3 months. If we can persuade users to make the usage of our device a convenient lifestyle choice, we may be able to influence the quality of life of the elderly in a very positive way. If we can persuade younger people to utilize our device to a high degree, they may have superior ambulation and bone mass when they become elderly.
Individuals who use the device at every opportunity should be more likely candidates for type 2 diabetic control than those who use the device sparingly. Dunstanet al (see: "Effects of Strength Training and Diet on Glycaemic Control in Older Persons with Type 2 Diabetes" - Appendix) found that high intensity strength training in diabetics, when feasible, combined with a moderate energy restriction may provide an effective management strategy.
And, finally, Jitramontree lists several benefits of walking:

Regular walking in elders can improve health, enhance independent living, increase overall quality of life, and reduce the risk of premature death in the following ways as it:

  • lowers the risk of developing hypertension (or reduces blood pressure), Type II diabetes Mellitus, colon cancer, and coronary heart disease (or second heart attack)
  • lowers blood cholesterol and triglycerides and may increase high density lipoproteins (HDL)
  • reduces depressive symptoms
  • promotes psychological well-being
  • helps build and maintain healthy body weight, bones, muscles and joints
  • helps older adults become stronger and better able to be active without falling or become excessively fatigued(15)

References

  1. Lee KC, Lanyon LE. Mechanical loading influences bone mass through estrogen receptor alpha. Exerc Sport Sci Rev. 2004 Apr;32(2):64-8. Review
  2. Maimoun L, Mariano-Goulart D, Couret I, Manetta J, Peruchon E, Micallef JP, Verdier R, Rossi M, Leroux JL. Effects of physical activities that induce moderate external loading on bone metabolism in male athletes. J Sports Sci. 2004 Sep;22(9):875-83.
  3. Vuori, I. (1996). Peak bone mass and physical activity: a short review. Nutrition Reviews, 54 (4), S11-S13.
  4. Alekel, L., Clasey, J. L., Fehling, P. C., Weigel, R. M., Boileau, R. A., Erdman, J. W., and Stillman, R. (1995). Contributions of exercise, body composition, and age to bone mineral density in pre-menopausal women. Medicine and Science in Sports and Exercise, 27 (11), 1477-1485.
  5. Drinkwater, B. L. (1995). Weight-bearing exercise and bone mass. Physical Medicine and Rehabilitation Clinics of North America, 6 (3), 567-577.
  6. Drinkwater, B. L. (1996). Exercise and bones. The American Journal of Sports Medicine, 24 (6), S33-S35.
  7. Sowers, M. R. (1993). Epidemiology of bone mass in pre-menopausal women. Epidemiologic Reviews, 15 (2), 374-394.
  8. Teegarden, D., Proulx, W. R., Kern, M., Sedlock, D., Weaver, C. M., Johnston, C. C., and Lyle, R. M. (1996). Previous physical activity relates to bone mineral measures in young women. Medicine and Science in Sports and Exercise, 28, 105-113.
  9. Cussler EC, Lohman TG, Going SB, Houtkooper LB, Metcalfe LL, Flint-Wagner HG, Harris RB, Teixeira PJ. Weight lifted in strength training predicts bone change in postmenopausal women. Med Sci Sports Exerc. 2003 Jan;35(1):10-7.
  10. Bone, Estrogen, Strength Training (BEST) Study, extracted from FITBONES a publication of The Arizona Osteoporosis Coalition and Metcalfe L, Lohman T, Going S, Houtkooper L, et al. Postmenopausal Women and Exercise for Prevention of Osteoporosis. ACSM"S Health and Fitness Journal May/June 2001.
  11. Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60.
  12. Morris JN, Hardman AE. Walking To Health. Sports Med. 1997 May;23(5):306-32
  13. Shangold, MM. Exercise in the Menopausal Woman. Obstet Gynecol. 1990 Apr;75(4 Suppl):53S-58S; discussion 81S-83S.
  14. Ades PA, Ballor DL, Ashikage T, Utton JL, Nair KS. Weight Training Improves Walking Endurance in Healthy Elderly Persons. Intern Med 1996 Mar 15;124(6):568-72.
  15. Jitramontree N. Evidence-based protocol. Excercise promotion: walking in elders. Iowa City (IA): University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core; 2001 Feb. 53 p. [81 references] Print copies: Available from the University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core, 4118 Westlawn, Iowa City, IA 52242. For more information, please see the University of Iowa Gerontological Nursing Interventions Research Center Web site.

Appendix

Exercise as a Long Term Anti-Depressant in the Elderly

Nalin A Singh (Royal Prince Alfred and Balmain Hospital, Sydney, Australia).

Karen Clements & Maria A Fiatarone (The Division on Ageing, Harvard Medical School and the Jean Mayer United States Department of Agriculture Human Nutrition Research Centre on Ageing at Tufts University, Boston and The Hebrew Rehabilitation Centre for Aged, Roslindale, Mass, USA.)
The 16th Congress of the International Association of Gerontology, Inc Bedford Park, S Australia 1997: Abstract no 1044

Introduction

Clinical depression is now accepted as a recurrent disorder. Any worthwhile treatment must not only be effective but feasible over the long term. We explored weight lifting as one such treatment.

Design

A 20 week randomised controlled trial of weight lifting vs an attention-control group. Training was supervised in weeks 0 to 10. In weeks 10 to 20 subjects self trained either at home or in a Centre unsupervised.

Measures

Blinded outcome measures included Beck Depression Inventory (BDI), Hamilton rating Scale of Depression (HRSD), Geriatric Depression Scale (GDS). Philadelpia Geriatric Morale Scale (PGMS), Ewarts Self Efficacy Scale (ESES).

Subjects

All subjects were community dwelling, aged >60 with a diagnosis of major or minor depression or dysthymia.

Results

A total of 32 subjects aged (60-84) were randomised. Of exercisers randomised 16/17 ((4%) continued unsupervised in weeks 10 - 20. Median compliance in exercisers in the unsupervised weeks 10 - 20 was 100% (35-100). Weight lifting significantly reduced all depression measures over 20 weeks (BDI in exercisers 19.9+1.8 to 6.7+1.5 versus control 18.0+2.0 to 11.1+2.5, p=0.003: HRSD in exercisers 11.6+1.0 to 6.3+1.0 versus controls 11.2+1.2 to 7.2+1.6,p=0.05. GDS in exercisers 16.2+1.7 to 8.0+1.8 versus controls 13.7+1.6 to 10.6+2.2, p=0.0009). The significant antidepressant effect was seen in both major and n\minor depression. Morale improved significantly in the exercise group, (p=0.03), as did self efficacy in jogging, (p=0.02).

Conclusion

Weight lifting was an effective, safe and feasible antidepressant in both supervised and unsupervised settings over 20 weeks.

"BANKING" AGAINST OSTEOPOROSIS

Children as young as 7-8 years old can significantly increase bone mass through a brief, specific exercise regimen. This may help them "bank" extra bone to prevent osteoporosis when they are much older, according to a study at Oregon State University.

The critical component, researchers say, is "impact loading" exercises that boost bone mass in a targeted area - especially the hips.

In the study, volunteers jumped off two-foot boxes 100 times, three times a week for seven months. The result: they had more than 5 percent higher bone mass than a control group who used the time for stretching and non-impact exercise.

A nationally recognized program in bone research and exercise
"A 5.6 percent increase translates into a 30 percent decrease in the risk of a hip fracture at adulthood," says Christine Snow, director of the OSU Bone Research Laboratory and principal investigator in the study.
Snow received a major three-year, $400,000 grant from the National Institutes of Health (NIH) to follow up with a more comprehensive research project. She hopes to determine whether children maintain that edge when the activity ceases, and whether there is any increase in bone mass in the spine.
The researchers will also evaluate the bone density of parent volunteers, to find out the contribution of genetics.
"The jumps take only 10 minutes - easy to incorporate into a school's schedule," Snow says. "We also teach the kids about skeletal systems, and the importance of exercise, fitness and nutrition."
During the last 10 years, OSU has developed a nationally recognized program in bone research and exercise. Much of the research indicates that the best way to increase bone mass in the hips is through high-impact exercise.
"It is increasingly evident that the best method for preventing osteoporosis is to bank bone mass in childhood, and maintain as much as you can through your adult years," Snow says.
Each year, some 300,000 elderly Americans suffer hip fractures, leading to hospitalization, incapacitation, and even death. It is a painful $14 billion annual health care problem.
The Bone Research Program estimates if their efforts lead to a decrease in hip fractures in older Oregonians by as little as 10%, a reduction in state health care costs in excess of $16 million per year would be realized, in addition to minimizing pain and suffering of many.

Effects of Strength Training and Diet on Glycaemic Control in Older Persons with Type2 Diabetes.
D Dunstan(1). R Daly (2), E Lekhtman (1), H Bauzon (1), L Robinson (2), K McConell (1), M de Courten (1), N Owen, P Zimmet (1).

1 International Diabetes Institute, Caulfield, Melbourne Australia.
2 School of Health Science, Deakin University, Melbourne Australia.

Introduction : The typical recommendation to combine endurance type exercise with diet may be comprised in older person with Type 2 diabetes because of the normal age related decline in muscle strength and function. Strength training (ST) may offer a plausible alternative because of its known effects on muscle strength, size and function. It may also compliment weight loss through the preservation, or increase in lean body mass (LBM).

Aim : The aim of the study was to investigate the long term effects of high intensity ST combined with moderate energy restriction on glycaemic control and body composition in older person with Type 2 diabetes.

Subjects : 28 overweight (BMI)>27kg/m2 ), sedentary men and women (mean+SE; age 6.7.1+1.0 years) with established (>6months) Type 2 diabetes.

Design : Participants were randomised to either:
1) 1) ST (3wk, 3 sets/8 reps@ 75-85%1RM) with moderate energy restriction (ST+Diet)
2) 2) Placebo exercise (stretching, 3/wk) with moderate energy restriction
3) 3) A third non-randomised group served as controls.
Weight, muscle strength, HbA1c LBM and fat mass (FM) (measured by DXA) were measured before and after 6 months.

Findings : The table show baseline results & % change (in parenthesis) after 6 months.
ST + Diet (n=12) Diet (n=9) Control (n=7)
Weight (kg) 88.9+2.6 (-3.2%)+ 90.2+3.9(-3.4%)+ 90.4+2.9 (-1.5%)
FM (kg) 31.0+1.6(-6.9%)· 35.2+2.0 (-5.4%)# 39.4+2.1(=0.9%)
LBM (kg) 53.0+2.2 (+0.9%)* 51.6+3.3 (-0.8%) 48.9+3.9 (-0.6%)
HbA1c 8.0+0.2 (-14.2%))·a 7.8+0.4 (-5.5%)* 7.0+0.2 (+0.4%)
p<0.05 vs diet, *p<0.5 vs controls (mean+SE)

The mean exercise attendance was 95% and 84% fort the ST +Diet and Diet only groups respectively. Muscle strength for all exercises improved significantly after ST. Although moderate decreases in BM and FM were observed for booth the ST + Diet and Diet Groups , the only intergroup difference detected was the ^FM between the ST + Diet and controls after 6 months. There were no significant changes in LBM. A 14.2% reduction in HbA1c from baseline observed following ST (-1.21 + 0.2%) was significantly different (p<0.05) to the changes observed in both the Diet (-0.5 + 0.3) and Control (-0.1 + 0.3) groups. These observations remained significant after adjustment for fat mass changes.

Conclusion : These finding show that high intensity strength training is feasible in older persons with Type 2 diabetes and when combined with moderate energy restriction may offer an effective management strategy.