Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

NCT ID: NCT05745844

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2027-06-30

Brief Summary

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

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

activity sessions

Intervention Type: OTHER

77 activity sessions ; muscle strengthening, testing or unloading

Control Group

The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.

Group Type: ACTIVE_COMPARATOR

activity sessions

Intervention Type: OTHER

77 activity sessions ; muscle strengthening, testing or unloading

Interventions

activity sessions

77 activity sessions ; muscle strengthening, testing or unloading

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital privé Pays de Savoie

Annemasse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Célia LLORET LINARES, MD

Role: CONTACT

celialloret@yahoo.fr

632494057 ext. +33

Facility Contacts

Célia LLORET-LINARES, MD

Role: primary

celialloret@yahoo.fr

632494057 ext. +33

Other Identifiers

2022-A00904-39

Identifier Type: -

Identifier Source: org_study_id