- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397462
Blood Flow and Bone Density in Healthy Adult Women
September 15, 2016 updated by: Kenneth McLeod, Binghamton University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Density of Proximal Femur
Time Frame: One year
|
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proximal Tibia Bone Density
Time Frame: One year
|
Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth McLeod, PhD, Binghamton University SUNY, BioEngineering
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 7, 2006
First Posted (Estimate)
November 9, 2006
Study Record Updates
Last Update Posted (Estimate)
September 26, 2016
Last Update Submitted That Met QC Criteria
September 15, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CSERC-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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