Blood Flow and Bone Density in Healthy Adult Women

Bone Loss Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397462
• Other study ID #: CSERC-005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 7, 2006
• Last updated: April 28, 2008
• Start date: October 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2008
• Source: Binghamton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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. The subjects will be asked to complete a detailed health history and health habits survey that will focus on issues related to risk factors for osteoporosis. 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. Venous circulation will be reassessed at 3 months and 6 months as well. The health history and lifestyle information will be assessed at each of three month intervals to discover any changes that might impact the efficacy of this research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss
• Muscle Hypotonia
• Muscle Tone Poor

Intervention

Device:
• plantar micromechanical stimulation

Locations

Country	Name	City	State
United States	CSERC Binghamton University	Binghamton	New York

Sponsors (3)

Lead Sponsor	Collaborator
Binghamton University	Juvent, Inc, New york State Office of Science Technology and Academic Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Density of proximal femur, lumbar spine and tibia
Secondary	Venous status muscle pump effectiveness