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Resistance Training and Testosterone After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01652040
First received: July 13, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

The goal of this proposal is to investigate the efficacy of a complimentary approach of evoked resistance training and testosterone replacement therapy on the changes in body composition and metabolic profile after SCI. The proposed method could become a recommended and simple intervention especially for individuals with limited access and poor tolerance to exercise. The rationale is based on the evidence that individuals with SCI experience decline in anabolic hormones which may be responsible for the deterioration in body composition and metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and subsequently cardiovascular disease. The designed study will provide explanation to the adaptations in the energy source of the muscle cells in response to training.


Condition Intervention
Spinal Cord Injury
Procedure: Resistance Training and Testosterone Patches
Drug: Testosterone Patches

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in body composition fat mass


Secondary Outcome Measures:
  • Metabolic Profile [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Glucose, lipid, inflammatory biomarkers, Basal Metabolic Rate


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT+Tp
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Procedure: 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.
Experimental: Tp
Applying Testosterone patches
Drug: Testosterone Patches
The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.

Detailed Description:

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. We 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652040

Contacts
Contact: Ashraf Gorgey, PhD PT (804) 675-5000 ext 3386 ashraf.gorgey@va.gov
Contact: Robert A Adler, MD (804) 675-5424 Robert.Adler@va.gov

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA Recruiting
Richmond, Virginia, United States, 23249
Contact: Robert C Dresch    804-675-5151    robert.dresch@va.gov   
Contact: Franklin J Zieve, MD PhD    (804) 675-5151    franklin.zieve@va.gov   
Principal Investigator: Ashraf Gorgey, PhD PT         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Ashraf Gorgey, PhD PT Hunter Holmes McGuire VA Medical Center, Richmond, VA
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01652040     History of Changes
Other Study ID Numbers: B7867-W
Study First Received: July 13, 2012
Last Updated: September 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injury
Rehabilitation
Electrical Stimulation
Testosterone
Body Composition
Lipid and Glucose profile
Ectopic Adiposity

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014