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临床试验/NCT01652040
NCT01652040已完成2 期

Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年7月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
26
试验地点
1
主要终点
Body Composition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

RT+Tp

Experimental

Resistance training using electrical stimulation and ankle weights and Testosterone patches

干预措施: Resistance Training and Testosterone Patches (Device)

Tp

Experimental

Applying Testosterone patches

干预措施: Testosterone Patches (Drug)

结局指标

主要结局

Body Composition

时间窗: 16 weeks

Changes in body composition fat mass

次要结局

  • Metabolic Profile(16 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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