Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Quadriceps muscle strength
研究概览
简要总结
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.
详细描述
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
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
干预措施: activity sessions (Other)
Control Group
The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.
干预措施: activity sessions (Other)
结局指标
主要结局
Quadriceps muscle strength
时间窗: 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.
次要结局
未报告次要终点