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Completed

NCT Number: NCT00397462

Blood Flow and Bone Density in Healthy Adult Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Bone Density of Proximal Femur

    Time frame: One year

    Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)

Secondary outcomes

  1. Proximal Tibia Bone Density

    Time frame: One year

    Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Collaborators

  • Juvent, Inc
  • New york State Office of Science Technology and Academic Research

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2006
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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