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| Name | Class |
|---|---|
| Juvent, Inc | INDUSTRY |
| New york State Office of Science Technology and Academic Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No change to usual behavior | |
| Low dose | Experimental | Request that calf muscle pump stimulation be used less than four hours per day |
|
| High dose | Experimental | Request that calf muscle pump stimulation be used at least four hours per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calf muscle pump stimulation | Device | Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density of Proximal Femur | Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal Tibia Bone Density | Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA) | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth McLeod, PhD | Binghamton University SUNY, BioEngineering | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Low Use | requested that they use the intervention during only the morning or afternoon up to 4 hours |
| FG001 | Group 2 High Use | requested that they use the intervention as much as possible during the work day |
| FG002 | Control | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Low Use | requested that they use the intervention during only the morning or afternoon up to 4 hours |
| BG001 | Group 2 High Use | requested that they use the intervention as much as possible during the work day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Density of Proximal Femur | Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA) | Posted | Mean | Standard Error | percent change in bone density | One year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Low Use | requested that they use the intervention during only the morning or afternoon up to 4 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Kenneth McLeod | Binghamton University, SUNY | (607)777-5779 | kmcleod@binghamton.edu |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D055948 | Sarcopenia |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| BG002 | Control | No use of the intervention |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Request that calf muscle pump stimulation be used at least four hours per day calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart |
|
|
| Secondary | Proximal Tibia Bone Density | Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA) | Posted | Mean | Standard Error | percent change in bone density | One year |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Group 2 High Use | requested that they use the intervention as much as possible during the work day | 0 | 13 | 0 | 13 |
| EG002 | Control | did not use the intervention | 0 | 15 | 0 | 15 |
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| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |