NCT06775119已完成不适用
Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
Institut de cancérologie Strasbourg Europe1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
研究概览
简要总结
This cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. These three visits will be conducted at a minimum interval of 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman
- •Informed consent
- •Age ≥ 18 years old
- •Affiliation to a social security system
- •Able to speak, read and understand French
- •Practice physical activity 1 to 5 times per week, without reaching a level of intense training or high-level performance.
排除标准
- •History of cancer
- •Any known chronic pathology
- •Protected minor or adult
- •Psychiatric, musculoskeletal or neurological problems
- •Implantation of a pacemaker
- •Pregnant woman
- •Presenting at least one contraindication to the use of transient blood flow occlusion
结局指标
主要结局
Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
时间窗: All measurements will be taken at the end of each of the four exercise bouts, during the same visit.
Significant changes in the level of peripheral fatigue during successive efforts as measured by the non invasive technique of nervous stimulation of the motor nerve.
次要结局
- Validate the feasibility of the test on the following secondary parameter: reproducibility of the test(2 to 7 days between sessions 2 and 3.)
- Correlation between peripheral fatigue and haemodynamic responses(Correlation between variables measured at the end of each of the four exercise bouts, during the same visit)
- Validate the feasibility of the test on the following secondary parameter: absence of transient discomfort(All measurements will be taken at the end of each of the four exercise bouts, during the same visit)
- Validate the feasibility of the test on the following secondary parameter: Tolerance to peripheral nerve stimulation using the self-reports of pain intensity scales.(All measurements will be taken during the same visit, at the end of each of the four exercise bouts)
研究者
研究点 (1)
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