Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: activity sessions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, longitudinal, open-label, comparative (two arms), randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroMuscular Electro Stimulation group<br>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 | Other: activity sessions<br>* 77 activity sessions ; muscle strengthening, testing or unloading<br>|
| Active Comparator: Control Group<br>The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre. | Other: activity sessions<br>* 77 activity sessions ; muscle strengthening, testing or unloading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps muscle strength | 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 |