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NCT01093014 · ClinicalTrials.gov registry record · NA
Novel Intervention to Influence Muscle Plasticity in Veterans
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT01093014: Completed NA study, sponsored by VA Office of Research and Development.
NCT01093014 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01093014, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of overall health for individuals with complete spinal cord injury (SCI). Increased protein catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the risk of fracture and contributes to increased mortality in Veterans with SCI. Metabolic syndrome and diabetes lead to heart disease in Veterans with SCI at higher rates than the general population. Exercise methods to sustain muscle tissue, bone density, and metabolic stability after SCI are lacking scientific justification. If left unchecked, the secondary complications of SCI can be health limiting or even life threatening to Veterans with paralysis. The importance of maintaining the health of the musculoskeletal system after SCI has never been greater as a cure for paralysis may become a reality. Contemporary rehabilitation interventions lack the ability to functionally load muscle tissue, quantify the dose of load, stress the cardiovascular system, monitor the overall stresses during daily exercise training, or offer portability to improve compliance with the exercise. The long-term goal of this project is to establish the optimal dose of muscle and bone stress during functional exercise in order to improve the health of Veterans with complete paralysis. The practical outcome of this research is to offer a form of activity that is feasible, portable, and grounded in sound scientific principles. The scientific goal is to understand whether the dose of force generated in paralyzed muscle via evoked contractions is critical to muscle atrophy/hypertrophy molecular pathways, physiologic performance, and insulin sensitivity. The investigators will administer various doses of muscle force by manipulating the frequency of electrical stimulation while keeping stimulation current (i.e. muscle fiber recruitment) constant. Interestingly, no previous study has examined the dose of muscle force necessary to
Primary Outcome
Muscle force evoked during high-force muscle stimulation
Interventions
- BEHAVIORAL Low-force muscle stimulation
- BEHAVIORAL High-force muscle stimulation
- BEHAVIORAL Sequential low-force and high-force muscle stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01093014 record still lists
NCT01093014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Low-force muscle stimulation is the first listed.
NCT01093014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01093014 about?
NCT01093014 is a clinical study titled "Novel Intervention to Influence Muscle Plasticity in Veterans". The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of overall health for individuals with complete spinal cord injury (SCI). Increased protein catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the risk of fracture and contr...
What is the current status of trial NCT01093014?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2011-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01093014?
The interventions under investigation include: Low-force muscle stimulation (BEHAVIORAL), High-force muscle stimulation (BEHAVIORAL), Sequential low-force and high-force muscle stimulation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01093014?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01093014's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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