Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05745844

Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé Pays de Savoie

Annemasse, 74100, France

Location status: Recruiting

Location contact

Célia LLORET-LINARES, MD

CONTACT

[email protected]

632494057 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

activity sessions

Other

77 activity sessions ; muscle strengthening, testing or unloading

Primary outcomes

  1. Quadriceps muscle strength

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Célia LLORET LINARES, MD

CONTACT

[email protected]

632494057 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: HORMES

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.