Resistance Training and Testosterone After Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT01652040|
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Resistance Training and Testosterone Patches Drug: Testosterone Patches||Phase 2 Phase 3|
Individuals with spinal cord injury (SCI) are at a lifelong risk of increasing obesity and several chronic metabolic disorders such as glucose intolerance, insulin resistance and dyslipidemia secondary to deterioration in body composition. Within few weeks of injury, there are significant decrease in whole body fat-free mass (FFM), particularly lower extremity skeletal muscle mass and subsequent increase in fat mass (FM). Resistance training (RT) is an important type of exercise that has been shown to induce positive physiological adaptations such as increasing lean mass and reducing metabolic disorders in other clinical populations.
In a pilot work, the investigators provided evidence that evoked RT using surface neuromuscular electrical stimulation (NMES) for knee extensor muscle group resulted in significant increase skeletal muscle cross-sectional area (CSA), reduction in % leg FM and a trend towards decrease in visceral adipose tissue (VAT) CSA. The favorable adaptations in body composition were associated with decrease in plasma insulin area under the curve and plasma triglycerides. The investigators attributed the adaptations in body composition and metabolic profile to an associated increase in plasma insulin-like growth factor (IGF-1). The investigators concluded that twelve weeks of evoked RT targeted towards evoking skeletal muscle hypertrophy could result in significant body composition and metabolic adaptations in individuals with SCI.
It is unclear if a longer RT program greater than 12 weeks would provide additional benefits to Veterans with SCI. It is also unknown whether enhancing the decline anabolic homeostasis by providing testosterone (T) replacement therapy (TRT) would reverse body composition and metabolic profile changes in Veterans with SCI. The major research goal of this proposal is to investigate the effects of 16 weeks of evoked RT+TRT vs. TRT on body composition (muscle CSA, VAT, %FM) and the metabolic profiles (glucose and lipid metabolism) in individuals with motor complete SCI. To address this goal, surface NMES accompanied with ankle weights will be conducted twice weekly to exercise the knee extensor skeletal muscle groups from sitting position. After 4 weeks of delayed entry approach, participants (n =24) will be randomly assigned into RT+TRT (n =12) or TRT (n =12) groups. The TRT will be provided via transdermal T patches that will be alternated on both shoulders over the course of the study. The investigators also propose to study the effects of detraining on body composition and metabolic profiles.
The research plan includes three specific aims
Specific aim 1 will demonstrate the effects of NMES RT and/or Testosterone patches (Tp) on the CSA of thighs and legs skeletal muscle groups, percentage FFM, and the CSA of VAT, intramuscular fat and percentage FM after 16 weeks of training+Tp and 16 weeks of detraining.
Specific aim 2 will determine the changes in metabolic milieu (resting energy expenditure, glucose homeostasis, lipid profile, free fatty acids, serum total and free testosterone and IGF-1), and cytokines (c-reactive protein, tumor necrosis factor alpha and IL-6 as inflammatory biomarkers) after 16 weeks of training+Tp and detraining.
Specific aim 3 will determine if 16 weeks of evoked RT and Tp will increase GLUT-4 concentration, muscle IGF-1 and peroxisome-proliferator-activated receptor-gamma co-activator 1 (PGC-1) expressions, altered fiber type distribution and enhance the mitochondrial enzymatic activities (electron transport chain) compared to Tp only.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Factorial Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury|
|Actual Study Start Date :||July 2, 2012|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||December 30, 2017|
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Device: Resistance Training and Testosterone Patches
We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
Applying Testosterone patches
Drug: Testosterone Patches
The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
- Body Composition [ Time Frame: 16 weeks ]Changes in body composition fat mass
- Metabolic Profile [ Time Frame: 16 weeks ]Basal Metabolic Rate
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Male with Spinal Cord Injury
- Between 18-50 years old
- BMI < 30 Kg/m2
- Traumatic motor complete C5-L2 level of injury
- American Spinal Injury Classification (A and B; i.e. motor deficit below the level of injury)
- Cardiovascular disease
- Uncontrolled type II DM and those on insulin
- Pressures sores stage 2 or greater
- Supra-physiological T level
- Hematocrit above 50%
- Urinary tract infection or symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652040
|United States, Virginia|
|Hunter Holmes McGuire VA Medical Center, Richmond, VA|
|Richmond, Virginia, United States, 23249|
|Principal Investigator:||Ashraf Gorgey, PhD PT||Hunter Holmes McGuire VA Medical Center, Richmond, VA|
Documents provided by VA Office of Research and Development:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||July 27, 2012 Key Record Dates|
|Results First Posted:||May 3, 2018|
|Last Update Posted:||May 3, 2018|
|Last Verified:||May 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Spinal Cord Injury
Lipid and Glucose profile
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal