Bone LossNCT00397462
Blood Flow and Bone Density in Healthy Adult Women
A study testing calf muscle pump stimulation in people with Bone Loss and Hypotensive, run by Binghamton University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Hypotensive, Lower Limb Fluid Pooling
- What is being tested?
- calf muscle pump stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women 30 - 60 years old
- work in seated positions
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Bone Loss, Hypotensive, Lower Limb Fluid Pooling
- Being tested
- calf muscle pump stimulation
- Keywords
- Osteoporosis, Sarcopenia, Calf muscle pump, Venous insufficiency, DEXA, Soleus muscle, APG
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Sarcopenia, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calf muscle pump stimulationDevice
Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: calf muscle pump stimulation |
| High dose | Experimental | Request that calf muscle pump stimulation be used at least four hours per day Receives: Device: calf muscle pump stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density of Proximal Femur
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
Measured: One year
Secondary outcomes (1)
Proximal Tibia Bone Density
Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvent, Inc, New york State Office of Science Technology and Academic Research
- Responsible party
- Principal investigator, Kenneth McLeod, Binghamton University
- Investigators
- Kenneth McLeod, PhD, Principal investigator, Binghamton University SUNY, BioEngineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397462
- Sponsor's protocol ID
- CSERC-005
- Status last verified
- Sep 2016
- First submitted
- 7 Nov 2006
- Last updated
- 26 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow and Bone Density in Healthy Adult Women
- ClinicalTrials.gov ID
- NCT00397462
- Acronym / sponsor ID
- CSERC-005
- Conditions
- Bone Loss, Hypotensive, Lower Limb Fluid Pooling
- Keywords
- Osteoporosis, Sarcopenia, Calf muscle pump, Venous insufficiency, DEXA, Soleus muscle, APG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Collaborators
- Juvent, Inc, New york State Office of Science Technology and Academic Research
- Study start
- Oct 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Nov 2006 (estimated)
- Results
- Posted 26 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No change to usual behavior |
| Low dose | Experimental | Device: calf muscle pump stimulationRequest that calf muscle pump stimulation be used less than four hours per day |
| High dose | Experimental | Device: calf muscle pump stimulationRequest that calf muscle pump stimulation be used at least four hours per day |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy women 30 - 60 years old
- work in seated positions
Key exclusion criteria (13 listed)
- weigh more than 350 pounds
- pregnant or plan to become pregnant
- professional athlete
- currently on Hormone Replacement Therapy
- currently taking medication for osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calf muscle pump stimulationMicromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart | Device | High dose, Low dose |
Primary outcome
Bone Density of Proximal Femur
Time frame: One year
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
1 secondary outcome
Proximal Tibia Bone Density
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth McLeod, PhD principal investigator
Binghamton University SUNY, BioEngineering
Questions about this trial
What is this clinical trial studying?
A study testing calf muscle pump stimulation in people with Bone Loss and Hypotensive, run by Binghamton University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density of Proximal Femur (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.