身体活動プログラムに加えて神経筋電気刺激の評価 (HORMES)
前立腺癌の抗ホルモン療法を受けている患者の管理 : 身体活動プログラムに加えた神経筋電気刺激の評価
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Annemasse、フランス、74100
- Hôpital privé Pays de Savoie
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:NeuroMuscular Electro Stimulation group
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 |
77 activity sessions ; muscle strengthening, testing or unloading |
|
アクティブコンパレータ:Control Group
The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre. |
77 activity sessions ; muscle strengthening, testing or unloading |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quadriceps muscle strength
時間枠: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. |
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。