Blood Flow and Bone Density in Healthy Adult Women

• ClinicalTrials.gov Identifier: NCT00397462
• Recruitment Status: Completed
• First Posted: November 9, 2006
• Results First Posted: September 26, 2016
• Last Update Posted: September 26, 2016
• Sponsor: Binghamton University
• Collaborators: Juvent, Inc; New york State Office of Science Technology and Academic Research
• Information provided by (Responsible Party): Kenneth McLeod, Binghamton University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Bone Loss; Hypotensive; Lower Limb Fluid Pooling	Device: calf muscle pump stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Blood Flow and Bone Density in Healthy Adult Women
• Study Start Date: October 2006
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures :

1. Bone Density of Proximal Femur [ Time Frame: One year ]
   Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)

Secondary Outcome Measures :

1. Proximal Tibia Bone Density [ Time Frame: One year ]
   Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)

Eligibility Criteria

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

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
• Other Study ID Numbers: CSERC-005
• First Posted: November 9, 2006
• Results First Posted: September 26, 2016
• Last Update Posted: September 26, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kenneth McLeod, Binghamton University:

Osteoporosis; Sarcopenia; Calf muscle pump; Venous insufficiency; DEXA; Soleus muscle; APG