Novel Intervention to Influence Muscle Plasticity in Veterans
NCT01093014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2016-03-10
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.
Conditions
- Spinal Cord Injuries
Interventions
- BEHAVIORAL
-
Low-force muscle stimulation
Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
- BEHAVIORAL
-
High-force muscle stimulation
Electrical stimulation of paralyzed muscle in seated or standing to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
- BEHAVIORAL
-
Sequential low-force and high-force muscle stimulation
Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
Sponsors & Collaborators
-
University of Iowa
collaborator OTHER -
VA Office of Research and Development
lead FED
Principal Investigators
-
Richard K Shields, PhD PT · Iowa City VA Health Care System, Iowa City, IA
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- United States
Study Locations
More Related Trials
-
Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury
NCT06907381 ·Status: ENROLLING_BY_INVITATION
-
Musculoskeletal Plasticity After Spinal Cord Injury
NCT02622295 ·Status: COMPLETED ·Phase: NA
-
Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury.
NCT05008484 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.
NCT06099340 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Spinal Cord Associative Plasticity for ALS
NCT06172621 ·Status: RECRUITING ·Phase: NA
-
Resistance Training and Testosterone After Spinal Cord Injury
NCT01652040 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
NCT01740128 ·Status: COMPLETED ·Phase: NA
-
Brain and Muscle Plasticity During Immobilization
NCT05115643 ·Status: COMPLETED ·Phase: NA
-
Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
NCT05921487 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
NCT03411720 ·Status: COMPLETED ·Phase: NA
-
Physiological Changes Induced Through MEP Conditioning in People With SCI
NCT04286191 ·Status: COMPLETED ·Phase: NA
-
Metabolic Health in Individuals With Spinal Cord Injury (SCI)
NCT03204240 ·Status: COMPLETED ·Phase: NA
-
Low Carbohydrate/High Protein Diet to Improve Metabolic Health
NCT03207841 ·Status: COMPLETED ·Phase: NA
-
Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)
NCT01302522 ·Status: COMPLETED ·Phase: PHASE2
-
Retraining Walking After Spinal Cord Injury
NCT00059553 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Transspinal-Transcortical Paired Stimulation for Neuroplasticity and Recovery After SCI
NCT04624607 ·Status: COMPLETED ·Phase: NA
-
Exercise to Reduce Obesity in Spinal Cord Injury
NCT00270855 ·Status: COMPLETED ·Phase: NA
-
Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
NCT03643770 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
FES Rowing for Skeletal Health After SCI
NCT02008149 ·Status: COMPLETED ·Phase: NA
-
Health Outcomes After Locomotor Training in Spinal Cord Injury
NCT02201173 ·Status: COMPLETED ·Phase: NA
-
High-intensity Interval Training in Patients With Spinal Muscular Atrophy
NCT06368076 ·Status: RECRUITING ·Phase: NA
-
Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
NCT02139436 ·Status: COMPLETED ·Phase: NA
-
Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
NCT02865343 ·Status: COMPLETED ·Phase: NA
-
Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia
NCT03146728 ·Status: COMPLETED
-
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
NCT04340063 ·Status: COMPLETED ·Phase: NA