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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
  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
Bone Loss
Hypotensive
Lower Limb Fluid Pooling
Device: calf muscle pump stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blood Flow and Bone Density in Healthy Adult Women

Resource links provided by NLM:


Further study details as provided by Binghamton University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 44
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: High dose
Request that calf muscle pump stimulation be used at least four hours per day
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

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.
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
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

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

Responsible Party: Kenneth McLeod, Professor, BioEngineering, Binghamton University
ClinicalTrials.gov Identifier: NCT00397462     History of Changes
Other Study ID Numbers: CSERC-005 
Study First Received: November 7, 2006
Results First Received: July 22, 2016
Last Updated: September 15, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 30, 2016