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Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program (HORMES)

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
activity sessions
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NeuroMuscular Electro Stimulation group

    Control Group

    Arm 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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2023
    Last Updated
    February 24, 2023
    Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05745844
    Brief Title
    Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
    Acronym
    HORMES
    Official Title
    Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, longitudinal, open-label, comparative (two arms), randomized study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NeuroMuscular Electro Stimulation group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.
    Intervention Type
    Other
    Intervention Name(s)
    activity sessions
    Intervention Description
    77 activity sessions ; muscle strengthening, testing or unloading
    Primary Outcome Measure Information:
    Title
    Quadriceps muscle strength
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Célia LLORET LINARES, MD
    Phone
    632494057
    Ext
    +33
    Email
    celialloret@yahoo.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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