Blood Flow and Bone Density in Healthy Adult Women

NCT ID: NCT00397462

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-01-31

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.

Conditions

Bone Loss; Hypotensive; Lower Limb Fluid Pooling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No change to usual behavior

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low dose

Request that calf muscle pump stimulation be used less than four hours per day

Group Type: EXPERIMENTAL

calf muscle pump stimulation

Intervention Type: DEVICE

Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart

High dose

Request that calf muscle pump stimulation be used at least four hours per day

Group Type: EXPERIMENTAL

calf muscle pump stimulation

Intervention Type: DEVICE

Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Juvent, Inc

INDUSTRY

Sponsor Role: collaborator

New york State Office of Science Technology and Academic Research

UNKNOWN

Sponsor Role: collaborator

Binghamton University

OTHER

Sponsor Role: lead

Responsible Party

Kenneth McLeod

Professor, BioEngineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth McLeod, PhD

Role: PRINCIPAL_INVESTIGATOR

Binghamton University SUNY, BioEngineering

Other Identifiers

CSERC-005

Identifier Type: -

Identifier Source: org_study_id