Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
調査の概要
状態
条件
詳細な説明
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
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Barcelona、スペイン、08003
- Hospital Del Mar
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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:
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration;
- Between 28 and 60 years of age;
- Clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines)
- Sufficient acculturation and fluency in the Spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities;
- Low physical activity, as measured by International Physical Activity Questionnaire, IPAQ;
- Signed informed consent
Exclusion Criteria:
- Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- Evidence of substance use disorder within the previous 3 months;
- mental retardation, i.e. premorbid intelligence quotient less than 70;
- Electroconvulsive therapy in previous 6 months.
- Somatic illnesses that contraindicate physical exercise.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Cognitive Remediation_Aerobic Exercise
Cognitive Remediation: 12 weeks of systematic cognitive training (REHACOP), performed 3 days per week in a 90-minutes-long sessions. Aerobic Exercise: 12 weeks of systematic aerobic exercise program, performed 3 days per week, lasting 40 minutes. |
Cognitive Remediation: The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas. Aerobic Exercise: 12 weeks of systematic aerobic exercise program. Patients will walk with a moderate intensity 10 minutes the first week and will increase gradually up to 30 minutes-walk with a moderate intensity. Patients will also perform 5 minutes of warm-up and stretching. |
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アクティブコンパレータ：Cognitive Remediation_Health Promotion
Cognitive Remediation: 12 weeks of systematic cognitive training (REHACOP), performed 3 days per week in a 90-minutes-long sessions. Health Promotion: 12 weeks of health promotion sessions, performed 3 days per week, lasting 40 minutes each. |
Cognitive Remediation: The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas. Health Promotion: 12 weeks of health promotion sessions. These sessions will be carried out by a specialized/trained nurse.
他の名前：
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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 |
時間枠 |
|---|---|
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Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
時間枠：3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
時間枠：15 months
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15 months
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Brain-derived neurotrophic factor (BDNF)
時間枠：3 months
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Núria Pujol, PhD、Parc de Salut Mar, Barcelona, Spain
- 主任研究者：Anna Mané, MD, PhD、Parc de Salut Mar, Barcelona, Spain
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PI15/00453
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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