Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
2016年12月19日 更新者：Chang Gung Memorial Hospital
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline.
The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.
調査の概要
状態
わからない
研究の種類
介入
入学 (予想される)
75
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chiayi City、台湾、613
- 募集
- Chiayi Chang Gung Memorial Hospital
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コンタクト：
- Shi-Zhe Lin, MS
- 電話番号：2688 +886-5-3621000
- メール：apirlline@cgmh.org.tw
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Kaohsiung City、台湾、83301
- 募集
- Kaohsiung Chang Gung Memorial Hospital
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コンタクト：
- Ku-Chou Chang, MD
- 電話番号：2285 +886-7317123
- メール：kcchang@cgmh.org.tw
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Keelung City、台湾、204
- 募集
- Keeling Chang Gung Memorial Hospital
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コンタクト：
- Chia-Ling Chen, PhD
- 電話番号：8147 +886-3-3281200
- メール：ccl1374@adm.cgmh.com.tw
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Taipei City、台湾、105
- 募集
- Taipei Chang Gung Memorial Hospital
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コンタクト：
- Chia-Ling Chen, PhD
- 電話番号：8147 +886-3-3281200
- メール：ccl1374@adm.cgmh.com.tw
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Taoyuan City、台湾、333
- 募集
- Taoyuan Chang Gung Memorial Hospital
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コンタクト：
- Chia-Ling Chen, PhD
- 電話番号：8147 +886-3-3281200
- メール：ccl1374@adm.cgmh.com.tw
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Taoyuan
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Kwei-Shan、Taoyuan、台湾、333
- 募集
- Chang Gung Memorial Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
- Age range from 20 to 90 years
- MMSE score ≥ 19
- MoCA<26
- Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
- Able to follow the study instruction
- Adequate cardiopulmonary function to perform aerobic exercise
- Able to walk with or without assistive devices
Exclusion Criteria:
- Unstable medical history (e.g., recent myocardial infarction) that might limit participation
- Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
- Current participation in another interventional trial
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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アクティブコンパレータ：Cognitive training group
One 60-min session of cognitive training.
Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.).
A saliva sample (2 mL) will only be collected once from each subject.
A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
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アクティブコンパレータ：Aerobic exercise training group
One 60-min session of aerobic exercise training.
Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.).
A saliva sample (2 mL) will only be collected once from each subject.
A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
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実験的：Sequential training group
One 30-min session of aerobic exercise training + one 30-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment. |
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 |
|---|---|---|
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Change scores of Montreal Cognitive Assessment (MoCA)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Useful Field of View (UFOV)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Stroop Color-Word test
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Dual-task test
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously.
The investigators will assess the dual-task performance during walking and performing box and block test.
The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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抗酸化マーカーのスコアを変更する
時間枠：ベースライン、事後テスト (予想平均 3 か月)
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抗酸化マーカーは、酸化ストレスの変化を反映するために使用されます。
特に、総抗酸化能力 (TAC) を分析します。
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ベースライン、事後テスト (予想平均 3 か月)
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血漿脂質レベルの変化スコア
時間枠：ベースライン、事後テスト (予想平均 3 か月)
|
コレステロール比（総コレステロールを高密度脂質で割った値）は、血中の脂質レベルを反映するために評価されます。
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ベースライン、事後テスト (予想平均 3 か月)
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Change scores of serum BDNF level
時間枠：Baseline, posttest (an expected average of 3 months)
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Baseline, posttest (an expected average of 3 months)
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Change scores of Glucose indicator
時間枠：Baseline, posttest (an expected average of 3 months)
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HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
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Baseline, posttest (an expected average of 3 months)
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Change scores of Functional Independence Measure (FIM)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Stroke Impact Scale (SIS)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Caregiver Burden (CB) scale
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of EuroQol (EQ)-5D questionnaire
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Timed up and go test (TUG)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Six-minute walk test (6MWT)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Mobility level
時間枠：Baseline, posttest (an expected average of 3 months)
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Baseline, posttest (an expected average of 3 months)
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Change scores of International Physical Activity Questionnaires (IPAQ)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Fugl-Meyer Assessment (FMA)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Rivermead Mobility Index (RMI)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of muscle strength
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer.
Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion.
We will record the mean value of 3 attempts.
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Community Integration Questionnaire (CIQ)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Geriatric Depression Scale (GDS)
時間枠：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Genotyping of the BDNF val66met polymorphism
時間枠：Between baseline and posttest (an expected average of 3 months)
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Between baseline and posttest (an expected average of 3 months)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
- Yeh TT, Wu CY, Hsieh YW, Chang KC, Lee LC, Hung JW, Lin KC, Teng CH, Liao YH. Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Aug 31;18(1):405. doi: 10.1186/s13063-017-2153-7.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年9月1日
一次修了 (予想される)
2018年8月1日
試験登録日
最初に提出
2015年9月6日
QC基準を満たした最初の提出物
2015年9月14日
最初の投稿 (見積もり)
2015年9月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月20日
QC基準を満たした最後の更新が送信されました
2016年12月19日
最終確認日
2016年12月1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。