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Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

19. december 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Chiayi City, Taiwan, 613
        • Rekruttering
        • Chiayi Chang Gung Memorial Hospital
        • Kontakt:
      • Kaohsiung City, Taiwan, 83301
        • Rekruttering
        • Kaohsiung Chang Gung Memorial Hospital
        • Kontakt:
      • Keelung City, Taiwan, 204
        • Rekruttering
        • Keeling Chang Gung Memorial Hospital
        • Kontakt:
      • Taipei City, Taiwan, 105
        • Rekruttering
        • Taipei Chang Gung Memorial Hospital
        • Kontakt:
      • Taoyuan City, Taiwan, 333
        • Rekruttering
        • Taoyuan Chang Gung Memorial Hospital
        • Kontakt:
    • Taoyuan
      • Kwei-Shan, Taoyuan, Taiwan, 333
        • Rekruttering
        • Chang Gung Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
  2. Age range from 20 to 90 years
  3. MMSE score ≥ 19
  4. MoCA<26
  5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  6. Able to follow the study instruction
  7. Adequate cardiopulmonary function to perform aerobic exercise
  8. Able to walk with or without assistive devices

Exclusion Criteria:

  1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
  2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
  3. Current participation in another interventional trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / 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.
Adfærdsmæssigt: Kognitiv træning
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.
Adfærdsmæssigt: Aerobic exercise training
Eksperimentel: 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.
Adfærdsmæssigt: Sequential combination of aerobic exercise and cognitive training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change scores of Montreal Cognitive Assessment (MoCA)
Tidsramme: 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)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Tidsramme: 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)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Tidsramme: 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)
Change scores of Useful Field of View (UFOV)
Tidsramme: 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)
Change scores of Stroop Color-Word test
Tidsramme: 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)
Change scores of Dual-task test
Tidsramme: 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.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændre antallet af antioxidative markører
Tidsramme: Baseline, posttest (et forventet gennemsnit på 3 måneder)
Antioxidative markører vil blive brugt til at afspejle ændringerne på oxidativt stress. Vi vil især analysere den samlede antioxidantkapacitet (TAC).
Baseline, posttest (et forventet gennemsnit på 3 måneder)
Ændre score for plasmalipidniveau
Tidsramme: Baseline, posttest (et forventet gennemsnit på 3 måneder)
Kolesterolforholdet (totalt kolesterol divideret med højdensitetslipid) vil blive evalueret for at afspejle lipidniveauet i blodet.
Baseline, posttest (et forventet gennemsnit på 3 måneder)
Change scores of serum BDNF level
Tidsramme: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of Glucose indicator
Tidsramme: Baseline, posttest (an expected average of 3 months)
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
Baseline, posttest (an expected average of 3 months)
Change scores of Functional Independence Measure (FIM)
Tidsramme: 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)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Tidsramme: 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)
Change scores of Stroke Impact Scale (SIS)
Tidsramme: 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)
Change scores of Caregiver Burden (CB) scale
Tidsramme: 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)
Change scores of EuroQol (EQ)-5D questionnaire
Tidsramme: 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)
Change scores of Timed up and go test (TUG)
Tidsramme: 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)
Change scores of Six-minute walk test (6MWT)
Tidsramme: 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)
Change scores of Mobility level
Tidsramme: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
Tidsramme: 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)
Change scores of Fugl-Meyer Assessment (FMA)
Tidsramme: 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)
Change scores of Rivermead Mobility Index (RMI)
Tidsramme: 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)
Change scores of muscle strength
Tidsramme: 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.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)
Tidsramme: 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)
Change scores of Geriatric Depression Scale (GDS)
Tidsramme: 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)
Genotyping of the BDNF val66met polymorphism
Tidsramme: Between baseline and posttest (an expected average of 3 months)
Between baseline and posttest (an expected average of 3 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chang Gung Memorial Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Forventet)

1. august 2018

Datoer for studieregistrering

Først indsendt

6. september 2015

Først indsendt, der opfyldte QC-kriterier

14. september 2015

Først opslået (Skøn)

16. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 104-4892A3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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