- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02550990
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Chiayi City, Taiwan, 613
- Rekrytering
- Chiayi Chang Gung Memorial Hospital
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Kontakt:
- Shi-Zhe Lin, MS
- Telefonnummer: 2688 +886-5-3621000
- E-post: apirlline@cgmh.org.tw
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Kaohsiung City, Taiwan, 83301
- Rekrytering
- Kaohsiung Chang Gung Memorial Hospital
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Kontakt:
- Ku-Chou Chang, MD
- Telefonnummer: 2285 +886-7317123
- E-post: kcchang@cgmh.org.tw
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Keelung City, Taiwan, 204
- Rekrytering
- Keeling Chang Gung Memorial Hospital
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Kontakt:
- Chia-Ling Chen, PhD
- Telefonnummer: 8147 +886-3-3281200
- E-post: ccl1374@adm.cgmh.com.tw
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Taipei City, Taiwan, 105
- Rekrytering
- Taipei Chang Gung Memorial hospital
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Kontakt:
- Chia-Ling Chen, PhD
- Telefonnummer: 8147 +886-3-3281200
- E-post: ccl1374@adm.cgmh.com.tw
-
Taoyuan City, Taiwan, 333
- Rekrytering
- Taoyuan Chang Gung Memorial Hospital
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Kontakt:
- Chia-Ling Chen, PhD
- Telefonnummer: 8147 +886-3-3281200
- E-post: ccl1374@adm.cgmh.com.tw
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Taoyuan
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Kwei-Shan, Taoyuan, Taiwan, 333
- Rekrytering
- Chang Gung Memorial Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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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Aktiv komparator: 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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Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change scores of Montreal Cognitive Assessment (MoCA)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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)
Tidsram: 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
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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Change scores of Dual-task test
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Ändra poängen för antioxidativ markör
Tidsram: Baslinje, posttest (ett förväntat genomsnitt på 3 månader)
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Antioxidativa markörer kommer att användas för att återspegla förändringarna på oxidativ stress.
I synnerhet kommer vi att analysera den totala antioxidantkapaciteten (TAC).
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Baslinje, posttest (ett förväntat genomsnitt på 3 månader)
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Ändra poängen för plasmalipidnivåer
Tidsram: Baslinje, posttest (ett förväntat genomsnitt på 3 månader)
|
Kolesterolkvoten (totalt kolesterol dividerat med högdensitetslipid) kommer att utvärderas för att återspegla lipidnivån i blodet.
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Baslinje, posttest (ett förväntat genomsnitt på 3 månader)
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Change scores of serum BDNF level
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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)
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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)
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 104-4892A3
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