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NCT04083794 · ClinicalTrials.gov registry record · NA
Exploration of Blood Flow Regulation to Bone in Humans
A NA study, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT04083794 is a NA study that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 90 participants.
The verdict
NCT04083794, a NA study, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
Without blood flow, bone cannot maintain its integrity. Bone blood flow responds to various local and systemic factors, however, bone perfusion in humans remains relatively unstudied. The investigators will study key mechanisms that regulate bone perfusion in able-bodied and contrast responses to those with spinal cord injury (SCI). SCI is a model of chronic reduced loading with loss of sympathetic regulation. In tibial cortical bone, the investigators will: 1) determine the impact of compressive loading with and without muscle contractions; 2) determine the impact of vascular sympathetic activity and systemic perfusion pressure; 3) compare the response between able-bodied and those with SCI. Acute metabolic needs of bone due to loading increase flow substantially. In addition, the bone vasculature is innervated by a rich network of sympathetic nerves that serve a functional purpose in the control of blood flow. A critical limitation to the study of bone blood flow in humans has been the lack of non-invasive assessments. Previously, the investigators developed a near infrared spectroscopy (NIRS) device to non-invasively assess blood content in bone and assessed tibial perfusion in response to exercise. Here, the investigators will test the hypothesis that bone blood flow increases proportional to loading conditions in both able-bodied individuals and those with SCI. The investigators will also test the hypothesis that there are decreases in blood bone flow that are proportional to increases in leg vascular sympathetic outflow in the able-bodied, but that changes in bone blood flow are proportional to changes in blood pressure in those with SCI. The proposed research will be some of the first to determine the control of bone flow in humans.
Interventions
- OTHER Laboratory based assessments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2023-04-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083794
The ClinicalTrials.gov registry entry for NCT04083794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Laboratory based assessments is the first listed.
NCT04083794 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04083794 about?
NCT04083794 is a clinical study titled "Exploration of Blood Flow Regulation to Bone in Humans". Without blood flow, bone cannot maintain its integrity. Bone blood flow responds to various local and systemic factors, however, bone perfusion in humans remains relatively unstudied. The investigators will study key mechanisms that regulate bone perfusion in able-bodied and contrast responses to th...
What is the current status of trial NCT04083794?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2018-05-31. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT04083794?
The interventions under investigation include: Laboratory based assessments (OTHER).
Who is sponsoring clinical trial NCT04083794?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
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