Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397462
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2006-11-07
Brief Title:
Blood Flow and Bone Density in Healthy Adult Women
Sponsor:
Binghamton University
Organization:
Binghamton University
Study Overview
Official Title:
Blood Flow and Bone Density in Healthy Adult Women
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 - 25 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 Kgm2 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 Meissners 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None