The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
2026年7月30日 更新者：LIN Jingxia Jessie、The Hong Kong Polytechnic University
Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial
The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.
調査の概要
研究の種類
介入
入学 (推定)
66
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。
研究連絡先
- 名前：Prof. Jessie LIN
- 電話番号：+852 2766 6718
- メール：jx-jessie.lin@polyu.edu.hk
研究場所
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Kowloon
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Hung Hom、Kowloon、香港
- The Hong Kong Polytechnic University
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Schizophrenia spectrum disorders;
- Aged from 18 to 65.
- Chinese-speaking (to enable cognitive testing).
- Ability to understand the nature of the study and to give informed consent.
- Fewer than 10 hours of physical exercise in the previous 3 months.
Exclusion Criteria:
- Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise with mild-to-moderate intensity may be contraindicated).
- Comorbid diagnoses of organic brain syndrome, substance misuse, history of epilepsy or seizure, intellectual disability, significant head trauma, active suicidal ideation or self-harm behaviors.
- Known pregnancy, or other contraindication to tDCS or MRI (e.g., have a cardiac/heart pacemaker, brain aneurysm clips, any implanted metallic or electrical device, or any internal metal foreign objects).
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：待機リスト コントロール グループ
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アクティブコンパレータ：Active tDCS and aerobic exercise
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Aerobic exercise training will be conducted twice per week, over a period of 6 weeks, supervised by a well-trained facilitator.
Each 45-minute session consists of a warm-up (10 minutes), treadmill walking (15 minutes), stationary bike cycling (15 minutes), and cool-down stretching (5 minutes).
Heart rate will be monitored throughout training by a wearable device, and 60% of the maximum heart rate (roughly calculated by 220-age) should be maintained for at least 20 minutes during each session.
Participants may stop exercising at any time if they feel uncomfortable.
Active tDCS will be applied using a wearable stimulator (Liftid) at a constant stimulation intensity of 1.2 mA for 20 minutes.
The device has been designed for anodal stimulation targeting the dorsolateral prefrontal cortex (DLPFC) using the F3 (anode) to F4 (cathode) montages.
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偽コンパレータ：Sham tDCS and aerobic exercise
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Aerobic exercise training will be conducted twice per week, over a period of 6 weeks, supervised by a well-trained facilitator.
Each 45-minute session consists of a warm-up (10 minutes), treadmill walking (15 minutes), stationary bike cycling (15 minutes), and cool-down stretching (5 minutes).
Heart rate will be monitored throughout training by a wearable device, and 60% of the maximum heart rate (roughly calculated by 220-age) should be maintained for at least 20 minutes during each session.
Participants may stop exercising at any time if they feel uncomfortable.
Sham tDCS will be performed using the same device but without stimulation.
During the aerobic exercise training, all participants will wear the device, and a facilitator will turn on the stimulation for participants receiving a-tDCS+AE intervention, and pretend to turn on the stimulation for participants receiving s-tDCS+AE intervention after the first 10-minute warm-up section.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hong Kong List Learning Test (HKLLT)
時間枠：Baseline and after the 6-week interventions
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A Chinese verbal memory test designed to assess the processes and organizational strategies involved in learning verbal information.
The test consists of two different 16-item two-character Chinese word lists, namely the random and blocked conditions.
Total learning score, short-term, and long-term memory will be recorded in both conditions.
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Baseline and after the 6-week interventions
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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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Rapid Visual Information Processing (RVP)
時間枠：Baseline and after the 6-week interventions
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A measure of sustained attention.
A white box is shown in the center of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute.
Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8).
When the participant sees the target sequence, they must respond by selecting the button in the center of the screen as quickly as possible.
The level of difficulty varies depending on whether the participant must watch for one- or three-target sequences at the same time.
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Baseline and after the 6-week interventions
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Digit Span (DGS)
時間枠：Baseline and after the 6-week interventions
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A measure of verbal short-term and working memory.
The participant will hear a sequence of digits and will immediately be prompted to verbally repeat it.
If the participant responds correctly, the next trial presents a longer sequence.
The task terminates when participants respond incorrectly on three occasions at a span length.
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Baseline and after the 6-week interventions
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The Verbal Fluency Test (VFT)
時間枠：Baseline and after the 6-week interventions
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A measure of executive function.
Participants have to name as many animals as possible in 60 seconds.
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Baseline and after the 6-week interventions
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6-Minute Walking Test
時間枠：Baseline and after the 6-week interventions
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A sub-maximal exercise test to assess the aerobic capacity and endurance.
The subject has to walk as far as possible along a track for 6 minutes.
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Baseline and after the 6-week interventions
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The Fatigue Assessment Scale (FAS)
時間枠：Baseline and after the 6-week interventions
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A 10-item self-report instrument that evaluates fatigue symptoms.
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Baseline and after the 6-week interventions
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The sit-and-reach test
時間枠：Baseline and after the 6-week interventions
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A common measure of flexibility, specifically assessing the lower back and hamstring muscles.
The subject is seated against the wall, arms outstretched towards the box.
A sliding ruler is used to measure the position of the fingertips.
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Baseline and after the 6-week interventions
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Standing Balance Test
時間枠：Baseline and after the 6-week interventions
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Give the subject a minute to practice their balancing before starting the test.
Then ask the person to stand on one foot for as long as possible.
The total length of time a person can stay in the balance position will be recorded.
The timing stops when the elevated foot touches the ground or the person hops or otherwise loses their balance position.
The test will be conducted with the person having their arms on their waist.
Repeat the test on the other leg.
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Baseline and after the 6-week interventions
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Positive and Negative Syndrome Scale (PANSS)
時間枠：Baseline and after the 6-week interventions
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Measuring symptom severity of patients with schizophrenia.
It contains 33 items across three subscales (Positive, Negative, and General), rated from 1-7 on each item based on clinical interviews as well as reports from family members or primary care hospital workers.
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Baseline and after the 6-week interventions
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Calgary Depression Scale (CDS)
時間枠：Baseline and after the 6-week interventions
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A 9-item scale to evaluate depression, rated from 0 to 3.
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Baseline and after the 6-week interventions
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Magnetic Resonance Imaging (MRI)
時間枠：Baseline and after the 6-week interventions
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Both structural and resting-state functional MRI will be acquired on a 3 Tesla MRI scanner (Prisma, Siemens, Germany).
For registration purposes, high-resolution T1-weighted anatomical images will be acquired during 3-D MP-RAGE (parameters: slice thickness=1mm, echo time=3.26ms,
repetition time=2250ms, inversion time=900ms, flip angle=9°, in-plane voxel size 1×1 mm2, acquisition time=5 minutes).
Functional scans (resting state) will use a gradient-echo echo-planar imaging (parameters: repetition/echo time=800/37ms; flip angle=52°; field of view=208mm; 2mm isotropic [no gap]; no. of dynamics=380, acquisition time=5 minutes).
The resting fMRI scan will be repeated for 5 times with a total acquisition time of 25 minutes.
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Baseline and after the 6-week interventions
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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。
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 (推定)
2026年9月1日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年7月30日
QC基準を満たした最初の提出物
2026年7月30日
最初の投稿 (実際)
2026年8月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月4日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
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その他の研究ID番号
- P0048824
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