Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

NCT05745844 | Terminated

• 1 other identifier: 2022-A00904-39
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NeuroMuscular Electro Stimulation group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Other: activity sessions

Interventions

activity sessions OTHER

77 activity sessions ; muscle strengthening, testing or unloading

Control Group; NeuroMuscular Electro Stimulation group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital privé Pays de Savoie

Annemasse, 74100, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, longitudinal, open-label, comparative (two arms), randomized study

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 27, 2023
• Study Start: December 20, 2023
• Primary Completion: August 4, 2026
• Study Completion: August 4, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)