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临床试验/NCT02739620
NCT02739620已完成不适用

Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors

University of Vermont2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Cross-sectional Area of Skeletal Muscle Fibers

研究概览

简要总结

Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • stage I, II or III breast cancer
  • receiving neoadjuvant or adjuvant chemotherapy with or without radiation
  • a body mass index <35 kg/m2.

排除标准

  • metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy
  • autoimmune, vascular or neuromuscular disease that could alter skeletal muscle
  • prior knee or hip replacement
  • contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy

结局指标

主要结局

Cross-sectional Area of Skeletal Muscle Fibers

时间窗: Difference between values at baseline at 2 months

Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

Intermyofibrillar Mitochondrial Content

时间窗: Difference between values at baseline at 2 months

Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

Maximal Calcium-activated Tension Single Muscle Fiber Tension

时间窗: Difference between values at baseline at 2 months

Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis

次要结局

  • Single Muscle Fiber Contractile Velocity(Difference between values at baseline at 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael J. Toth, Ph.D.

Associate Professor of Medicine

University of Vermont

研究点 (2)

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