Clinical trial · Interventional
Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
NCT05745844CI-TRIAL-00100917HORMESrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| activity sessions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NeuroMuscular Electro Stimulation group
- description
- 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
- interventionNames
- Other: activity sessions
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.
- interventionNames
- Other: activity sessions
Primary outcomes (1)
- measure
- Quadriceps muscle strength
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.