Bone Loss, Hypotensive, Lower Limb Fluid Pooling
Conditions
Keywords
Osteoporosis, Sarcopenia, Calf muscle pump, Venous insufficiency, DEXA, Soleus muscle, APG
Brief summary
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
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.
Interventions
Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
Sponsors
Juvent, Inc
New york State Office of Science Technology and Academic Research
Binghamton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density of Proximal Femur | One year | Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Tibia Bone Density | One year | Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Low Use requested that they use the intervention during only the morning or afternoon up to 4 hours | 16 |
| Group 2 High Use requested that they use the intervention as much as possible during the work day | 13 |
| Control No use of the intervention | 15 |
| Total | 44 |
Baseline characteristics
| Characteristic | Group 2 High Use | Control | Group 1 Low Use | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 15 Participants | 16 Participants | 44 Participants |
| Age, Continuous | 44.8 years STANDARD_DEVIATION 9.1 | 44.5 years STANDARD_DEVIATION 8.1 | 47.9 years STANDARD_DEVIATION 8.1 | 45.8 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 13 participants | 15 participants | 16 participants | 44 participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 16 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 | 0 / 15 |
Outcome results
Primary
Bone Density of Proximal Femur
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Bone Density of Proximal Femur | -0.133 percent change in bone density | Standard Error 0.37 |
| Low Dose | Bone Density of Proximal Femur | -.675 percent change in bone density | Standard Error 0.437 |
| High Dose | Bone Density of Proximal Femur | 1.3 percent change in bone density | Standard Error 0.382 |
Secondary
Proximal Tibia Bone Density
Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Proximal Tibia Bone Density | 1.14 percent change in bone density | Standard Error 1.14 |
| Low Dose | Proximal Tibia Bone Density | -2.111 percent change in bone density | Standard Error 0.64 |
| High Dose | Proximal Tibia Bone Density | 1.65 percent change in bone density | Standard Error 0.56 |