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

19. Dezember 2016 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

75

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verhalten: Kognitives Training
Aktiver 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.
Verhalten: Aerobic exercise training
Experimental: 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.
Verhalten: Sequential combination of aerobic exercise and cognitive training

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change scores of Montreal Cognitive Assessment (MoCA)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ändern Sie die Werte des antioxidativen Markers
Zeitfenster: Baseline, Posttest (ein erwarteter Durchschnitt von 3 Monaten)
Antioxidative Marker werden verwendet, um die Veränderungen des oxidativen Stresses widerzuspiegeln. Insbesondere werden wir die Gesamtantioxidationskapazität (TAC) analysieren.
Baseline, Posttest (ein erwarteter Durchschnitt von 3 Monaten)
Ändern Sie die Werte des Plasmalipidspiegels
Zeitfenster: Baseline, Posttest (ein erwarteter Durchschnitt von 3 Monaten)
Das Cholesterinverhältnis (Gesamtcholesterin geteilt durch hochdichtes Lipid) wird ausgewertet, um den Lipidspiegel im Blut widerzuspiegeln.
Baseline, Posttest (ein erwarteter Durchschnitt von 3 Monaten)
Change scores of serum BDNF level
Zeitfenster: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of Glucose indicator
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Between baseline and posttest (an expected average of 3 months)
Between baseline and posttest (an expected average of 3 months)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chang Gung Memorial Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2015

Primärer Abschluss (Voraussichtlich)

1. August 2018

Studienanmeldedaten

Zuerst eingereicht

6. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. September 2015

Zuerst gepostet (Schätzen)

16. September 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. Dezember 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Dezember 2016

Zuletzt verifiziert

1. Dezember 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 104-4892A3

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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