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Trial Title:
Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
NCT ID:
NCT05745844
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, longitudinal, open-label, comparative (two arms), randomized study
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
activity sessions
Description:
77 activity sessions ; muscle strengthening, testing or unloading
Arm group label:
Control Group
Arm group label:
NeuroMuscular Electro Stimulation group
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital privé Pays de Savoie
Address:
City:
Annemasse
Zip:
74100
Country:
France
Status:
Recruiting
Contact:
Last name:
Célia LLORET-LINARES, MD
Phone:
632494057
Phone ext:
+33
Email:
celialloret@yahoo.fr
Start date:
December 20, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class:
Other
Source:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745844
