除了身体活动计划外,神经肌肉电刺激的评估 (HORMES)
前列腺癌抗激素治疗患者的管理:除了身体活动计划外的神经肌肉电刺激评估
The purpose of the study is to measure the muscle strength of the quadriceps 6 months from the start of the intervention, either the maximum load resistance that can be lifted in a single repetition under standardized conditions with the thigh press.
研究概览
详细说明
This is a prospective, longitudinal, open, comparative (two arms), randomized, monocentric study, focusing on a therapeutic strategy (muscle strengthening program with or without NeuroMuscular ElectroStimulation).
Patients will be cared for according to a nutritional and sports support program offered routinely in the investigating center, which corresponds to the recommendations for the care of patients with prostate cancer under Androgen Deprivation Therapy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Annemasse、法国、74100
- Hôpital privé Pays de Savoie
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient treated with pharmacological androgen deprivation therapy for prostate cancer for more than 26 weeks;
- Performance index (WHO): 0 or 1;
- Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study;
- Patient benefiting from a social security scheme;
Exclusion Criteria:
- Weight ≥ 130 kg;
- Vegetarian food;
- Other associated neoplasia;
- Patient having undergone a bilateral orchiectomy;
- Painful bone metastases, or at risk of fracture;
- Anemia (hemoglobin < 10 g/dL);
- Thrombocytopenia (platelets < 50 G/L);
- Renal impairment (creatinine clearance < 60 mL/min, or albuminuria > 30);
- Patient planning to travel more than 4 weeks continuously in the next 52 weeks;
- Absolute contraindication to physical training (e.g. musculoskeletal, cardiovascular or neurological disorders), according to the doctor specializing in the associated medical condition;
- Contraindication to the use of the neuromuscular electrostimulation device or the impedance meter, in particular infectious disease in the acute phase, fungal infection, dermatitis, unbalanced arrhythmia, epilepsy, wearing an active implantable device (pacemaker, heart artificial, prosthesis incorporating an electromagnetic system), open wound;
- Sports activity already supervised by a third party or at an equal or higher level than the bodybuilding/muscle strengthening work recommended in the study;
- Protected adult patient (under guardianship or curatorship, or under a regime of deprivation of liberty);
- Patient participating in another research, or in a period of exclusion from another research.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:NeuroMuscular Electro Stimulation group
Patients in the NeuroMuscular Electro Stimulation group will also have neurostimulation sessions using a CE marked medical device, in its destination, according to its instructions for use, therefore without expected clinical risk |
77 activity sessions ; muscle strengthening, testing or unloading |
|
有源比较器:Control Group
The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre. |
77 activity sessions ; muscle strengthening, testing or unloading |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quadriceps muscle strength
大体时间:6 months
|
Muscular strength of the quadriceps at 6 months from the start of the intervention, i.e. the maximum resistance / load that can be lifted in a single repetition, under standardized conditions. The main analysis is the comparison of quadriceps muscle strength (Maximum Resistance raised in 1 repetition) at 6 months between the groups with neuromuscular electrical stimulation and without neuromuscular electrical stimulation. |
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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