Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how adding a special type of electrical stimulation for muscles, called neuromuscular electrostimulation, can help improve muscle strength in men with prostate cancer who are also participating in a physical activity program. The main focus is to see how much stronger the thigh muscles (quadriceps) become after six months of this combined treatment.

To be eligible for the study, participants need to be men aged 65 to 74 who have been receiving hormone therapy for prostate cancer for at least six months and are generally able to perform daily activities. They should also be able to understand the study's details and agree to participate. Participants will receive guidance on how to use the electrostimulation device and will engage in a physical activity plan. It’s important to note that individuals with certain health conditions, such as severe obesity, serious bone issues, or other major health problems, may not qualify for this trial. This study aims to provide insights into improving muscle strength, which can be beneficial for overall health and quality of life during cancer treatment.

Gender

MALE

Eligibility criteria

• 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.