Blood Flow and Bone Density in Healthy Adult Women

NCT00397462 | Completed Results

• 1 other identifier: CSERC-005
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Loss; Hypotensive; Lower Limb Fluid Pooling

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone Density of Proximal Femur

  Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)

  One year

Secondary Outcomes (1)

• Proximal Tibia Bone Density

  One year

Study Arms (3)

Control

NO INTERVENTION

No change to usual behavior

Low dose

EXPERIMENTAL

Request that calf muscle pump stimulation be used less than four hours per day

Device: calf muscle pump stimulation

High dose

EXPERIMENTAL

Request that calf muscle pump stimulation be used at least four hours per day

Device: calf muscle pump stimulation

Interventions

calf muscle pump stimulation DEVICE

Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart

High dose; Low dose

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy women 30 - 60 years old
• work in seated positions

You may not qualify if:

• 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

Sponsors & Collaborators

• Binghamton University: lead
• Juvent, Inc: collaborator
• New york State Office of Science Technology and Academic Research: collaborator

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Sarcopenia; Venous Insufficiency

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Professor Kenneth McLeod
• Organization: Binghamton University, SUNY

kmcleod@binghamton.edu

(607)777-5779

Study Officials

• Kenneth McLeod, PhD

  Binghamton University SUNY, BioEngineering

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, BioEngineering

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 9, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 26, 2016
• Results First Posted: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share