Blood Flow and Bone Density in Healthy Adult Women

Study Overview
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Brief Summary
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This project will test the efficacy of using a non-invasive neuromuscular stimulation on the plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult women.

Detailed Description
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Women between the ages of 30 and 60 years of age who work in positions that require them to be seated at desks for a large portion of each day, are capable of following the protocol for one year, have a t-score >- 2.5 (do not have osteoporosis), and respond to plantar stimulation will be asked to participate. Women will be excluded who are receiving medications for osteoporosis, taking hormone replacement therapy, taking steroids (either oral or inhaled), have metal implants in the tibia, hip and spine that interfere with DEXA (bone density) scanning, are professional or semi-professional athletes, have hyperparathyroidism, have a history of pulmonary embolism, deep vein thrombosis, peripheral vascular disease or varicose veins, have a Body Mass Index greater than 40 Kg/m2, have any type of neuromuscular disease, or are pregnant . Once the inclusion and exclusion criteria are met, 45 subjects will be randomized into 3 groups including 1) a group of 15 subjects who will use the device (stimulation) for up to 4 hours a day, 2) a group of 15 subjects that will use the device for up to 8 hours a day, and 3) a control group who will not use the device. Subjects in the two treatment groups will be asked to place their feet on a mechanical device that will deliver a slight vibration while they are seated at work. Vibrations between 30-60 Hz has been shown to stimulate the Meissner's corpuscles which in turn stimulate contraction of the deep muscles of the calves. This contraction has been shown to increase venous and lymphatic return from the lower extremities thus improve bone metabolism. Bone density readings and venous circulation will be measured at the onset of this research and will be repeated after 12 months of using the device.

Official Title
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Blood Flow and Bone Density in Healthy Adult Women

Conditions
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Bone Loss, Hypotensive, Lower Limb Fluid Pooling

Intervention / Treatment
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* Device: calf muscle pump stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy women 30 - 60 years old work in seated positions Exclusion Criteria: weigh more than 350 pounds pregnant or plan to become pregnant professional athlete currently on Hormone Replacement Therapy currently taking medication for osteoporosis currently on corticosteroids metal implants in tibia hip spine forearm diagnosed with hyperparathyroidism diagnosed with neuromuscular disease pulmonary embolism deep vein thrombosis peripheral vascular disease medications for hypertension

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No change to usual behavior | |
| Experimental: Low dose<br>Request that calf muscle pump stimulation be used less than four hours per day | Device: calf muscle pump stimulation<br>* Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart<br>|
| Experimental: High dose<br>Request that calf muscle pump stimulation be used at least four hours per day | Device: calf muscle pump stimulation<br>* Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Density of Proximal Femur | Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA) | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Tibia Bone Density | Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA) | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APG, Osteoporosis, Sarcopenia, Calf muscle pump, Venous insufficiency, DEXA, Soleus muscle