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Blood Flow and Bone Density in Healthy Adult Women

This study has been completed.
Sponsor:
Collaborators:
Juvent, Inc
New york State Office of Science Technology and Academic Research
Information provided by (Responsible Party):
Kenneth McLeod, Binghamton University
ClinicalTrials.gov Identifier:
NCT00397462
First received: November 7, 2006
Last updated: September 15, 2016
Last verified: September 2016

November 7, 2006
September 15, 2016
October 2006
January 2008   (final data collection date for primary outcome measure)
Bone Density of Proximal Femur [ Time Frame: One year ] [ Designated as safety issue: No ]
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
Bone Density of proximal femur, lumbar spine and tibia
Complete list of historical versions of study NCT00397462 on ClinicalTrials.gov Archive Site
Proximal Tibia Bone Density [ Time Frame: One year ] [ Designated as safety issue: No ]
Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)
Venous status muscle pump effectiveness
Not Provided
Not Provided
 
Blood Flow and Bone Density in Healthy Adult Women
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bone Loss
  • Hypotensive
  • Lower Limb Fluid Pooling
Device: 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
  • No Intervention: Control
    No change to usual behavior
  • Experimental: Low dose
    Request that calf muscle pump stimulation be used less than four hours per day
    Intervention: Device: calf muscle pump stimulation
  • Experimental: High dose
    Request that calf muscle pump stimulation be used at least four hours per day
    Intervention: Device: calf muscle pump stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
30 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00397462
CSERC-005
No
No
Not Provided
Kenneth McLeod, Binghamton University
Binghamton University
  • Juvent, Inc
  • New york State Office of Science Technology and Academic Research
Principal Investigator: Kenneth McLeod, PhD Binghamton University SUNY, BioEngineering
Binghamton University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP