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临床试验/NCT04013178
NCT04013178Unknown不适用

Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer

University of Calgary2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
试验地点
2
主要终点
Maximal Isometric Force in the Knee Extensors

研究概览

简要总结

People who receive radiation therapy for head and neck cancer (HNC) can experience side-effects which include a significant loss in body mass and a loss of muscle mass (cancer cachexia). Some research has shown success in the use of generic (dynamic) resistance training interventions for patients affected by head and neck cancer. However, this approach could be optimized with the use of novel training methods.The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.

详细描述

Background and Rationale

Patients who receive radiation therapy for head and neck cancer treatment are susceptible to side-effects such as a significant loss in body mass and a loss of muscle mass (cancer cachexia) compared to pre-treatment. In addition, radiation therapy treatment may cause cancer-related fatigue and a reduction in overall physical function and health-related quality of life. Some research has shown success in the use of generic (dynamic exercise) resistance training interventions when applied for head and neck cancer survivors. Typically, when the correct training principals are adhered to in healthy populations (i.e. progressive overload, specificity, variation, rest/recovery), muscle strength and muscle mass are effectively enhanced. However, these training variables may be less effective in eliciting positive outcomes in clinical populations in that they are less effective in increasing muscle mass and muscle strength. Exercise is beneficial for people affected by all cancer types, but resistance training may be particularly beneficial for people who have completed radiation therapy treatment for head and neck cancer. Alternative modalities may provide superior improvements in muscle strength and muscle mass. Therefore, further research is warranted to investigate optimized resistance training prescription in head and neck cancer patients.

Research Question & Objectives

The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.

Methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a verified clinical diagnosis of head and neck cancer (stage I-IV) with the primary tumor in the oral cavity, pharynx, larynx, paranasal sinuses, or salivary glands.
  • received radiation therapy ± concomitant chemotherapy
  • able to walk without assistance
  • received Canadian Society for Exercise Physiology-Certified Exercise Physiologist (CSEP-CEP) approval via The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and/or physician approval
  • willing/able to travel to the University of Calgary (Calgary, AB).

排除标准

  • comorbidities that could confound the ability to participate in laboratory tests (e.g. other malignancies, neuromuscular, musculoskeletal or vascular conditions affecting the lower extremities, such as radiculopathy or myopathy, (where the research team were consulted for individual cases)
  • presence of a percutaneous endoscopic gastrostomy
  • unable to follow verbal instructions in English

结局指标

主要结局

Maximal Isometric Force in the Knee Extensors

时间窗: Baseline and after the 12-week intervention

A change in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.

Assessment of change in Muscle Cross-Sectional Area

时间窗: Baseline and after the 12-week intervention

ultrasound measurement of the vastus lateralis and rectus femoris

次要结局

  • Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale(Baseline to after the 12-week intervention, at 6 month and 12 month follow up)
  • Potentiated Twitch Force(Baseline and after the 12-week intervention)
  • Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude(Baseline and after the 12-week intervention)
  • Body mass (kg)(Baseline and after the 12-week intervention)
  • Estimated body fat %(Baseline and after the 12-week intervention)
  • Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale(Baseline to after the 12-week intervention, at 6 month and 12 month follow up)
  • Time to volitional exhaustion(Baseline and after the 12-week intervention)
  • Voluntary Electromyography (EMG)(Baseline and after the 12-week intervention)
  • Body mass index(Baseline and after the 12-week intervention)
  • Voluntary Activation(Baseline and after the 12-week intervention)

研究者

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

Guillaume Millet

Professor

University of Calgary

研究点 (2)

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