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:
Binghamton University
ClinicalTrials.gov Identifier:
NCT00397462
First received: November 7, 2006
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Bone Loss
Muscle Tone Poor
Device: plantar micromechanical stimulation
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Binghamton University:

Primary Outcome Measures:
  • Bone Density of proximal femur, lumbar spine and tibia

Secondary Outcome Measures:
  • Venous status muscle pump effectiveness

Estimated Enrollment: 45
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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. 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397462

Locations
United States, New York
CSERC Binghamton University
Binghamton, New York, United States, 13902
Sponsors and Collaborators
Binghamton University
Juvent, Inc
New york State Office of Science Technology and Academic Research
Investigators
Principal Investigator: Kenneth McLeod, PhD Binghamton University SUNY, BioEngineering
  More Information

No publications provided

Responsible Party: Kenneth McLeod, Binghamton University, SUNY Bioengineering
ClinicalTrials.gov Identifier: NCT00397462     History of Changes
Other Study ID Numbers: CSERC-005
Study First Received: November 7, 2006
Last Updated: April 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Binghamton University:
Osteoporosis
Sarcopenia
Calf muscle pump
Venous insufficiency
DEXA
Soleus muscle
APG

Additional relevant MeSH terms:
Muscle Hypotonia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014