N/A
N=33
Novel Intervention to Influence Muscle Plasticity in Veterans
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01093014 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: HF Muscle Force — 23.9; 30.9 Newtons (N)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-force muscle stimulation (Behavioral); High-force muscle stimulation (Behavioral); Sequential low-force and high-force muscle stimulation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HF Muscle Force |
23.9; 30.9 | — |
| PRIMARY LF Muscle Force |
26.72; 27.58 | — |
| PRIMARY Skeletal Muscle Gene Regulation: MSTN |
.56; .67 | — |
| PRIMARY Skeletal Muscle Gene Expression: PPARGC1A |
5.46; 4.97 | — |
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 trigger adaptations in protein synthesis/degradation pathways. The investigators wish to discover the most effective method to maintain the molecular and physiologic properties of paralyzed muscle. The investigators believe such a method will be in urgent demand as a co-intervention with pharmaceutical strategies in post-SCI rehabilitation.
Eligibility Criteria
Inclusion Criteria
- Inclusion criteria for all subjects will be upper motor neuron lesions between the 10th thoracic and the 7th cervical spinal levels. The completeness of the injury will be verified by somatosensory evoked potentials.
Exclusion Criteria
- Subjects will be excluded if they have pressure ulcers
- chronic infection
- lower extremity muscle contractures
- deep vein thrombosis
- recent limb fractures
- muscle metabolic disorders
- any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction)
- or if they are pregnant or plan to become pregnant.
- Subjects with distal femur trabecular bone mineral density less than 50 mg/cm3 will be excluded from participation in quadriceps electrical stimulation training
Data sourced from ClinicalTrials.gov (NCT01093014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.