Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

Last updated: March 25, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

activity sessions

Clinical Study ID

NCT05745844
2022-A00904-39
  • Ages 18-90
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient treated with pharmacological androgen deprivation therapy for prostatecancer for more than 26 weeks;

  • Performance index (WHO): 0 or 1;

  • Patient able to understand the information related to the study, to read theinformation leaflet and having consented to participate in the study;

  • Patient benefiting from a social security scheme;

Exclusion

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, cardiovascularor neurological disorders), according to the doctor specializing in the associatedmedical condition;

  • Contraindication to the use of the neuromuscular electrostimulation device or theimpedance meter, in particular infectious disease in the acute phase, fungalinfection, dermatitis, unbalanced arrhythmia, epilepsy, wearing an activeimplantable device (pacemaker, heart artificial, prosthesis incorporating anelectromagnetic system), open wound;

  • Sports activity already supervised by a third party or at an equal or higher levelthan the bodybuilding/muscle strengthening work recommended in the study;

  • Protected adult patient (under guardianship or curatorship, or under a regime ofdeprivation of liberty);

  • Patient participating in another research, or in a period of exclusion from anotherresearch.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: activity sessions
Phase:
Study Start date:
December 20, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Hôpital privé Pays de Savoie

    Annemasse, 74100
    France

    Active - Recruiting

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