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Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

18 april 2014 bijgewerkt door: National Taiwan University Hospital

The purposes of this study are:

  1. To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
  2. To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
  3. To investigate the influence of different apolipoprotein E (APOE) genotypes on the above-mentioned exercise effects.

The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.

Studie Overzicht

Gedetailleerde beschrijving

Recent studies have shown that exercise training could decrease the risk of dementia in the elderly population. Exercise training could also slow down the speed of deterioration of memory and other cognitive functions in patients who already have mild cognitive impairment or early Alzheimer's disease. However, the mechanisms of such effects are still unknown. Whether exercise training could improve neural fiber integrity, blood flow, or motor performance of these patients also remain unexplored.

Therefore, the purposes of this study are:

  1. To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
  2. To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
  3. To investigate the influence of different APOE genotypes on the above-mentioned exercise effects.

We will conduct a single-blinded, randomized controlled clinical trial. We will recruit 60 patients with mild cognitive impairment or early Alzheimer's disease. The participants will be randomly classified into the exercise training group or control group. The exercise training group will receive health education and exercise training of moderate intensity, 3 times a week, for 12 weeks. The control group will receive health education only. Both groups will receive pre- (week 0), post- (week 12), and follow-up (week 24 after the end of the program) examinations for cognitive function, motor performance, diffusion tensor or diffusion spectrum magnetic resonance imaging, and transcranial duplex. We will compare the group differences on the aforementioned outcome measures brought by 12-week exercise training. We will also perform analysis of the correlations between the changes in these outcome measures to explore the possible neural or physiological mechanisms mediating the training effects. The effects of different APOE genotypes on these outcome measures will also be compared.

The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

19

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Taipei, Taiwan
        • National Taiwan University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 45~85 years old and had independent walking ability
  • The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal activity of daily living /instrumental activities of daily living, and not demented
  • Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (McKhann, et al., 1984)

Exclusion Criteria:

  • The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Exercise intervention
Aerobic exercise and dual-task training
Aerobic exercise and dual-task training
Actieve vergelijker: Stretch exercise
Stretch exercise & sitting balance
Stretch exercise & sitting balance

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Color Trails Test at week12 and Week24
Tijdsspanne: Baseline, Week12, Week24
To investigate the cognitive executive function
Baseline, Week12, Week24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in walking speed at week12 and Week24
Tijdsspanne: baseline, week12 and Week24
To investigate walking ability
baseline, week12 and Week24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Ming-Jang Chiu, PhD, Neurology department, National Taiwan University Hospital
  • Hoofdonderzoeker: Yu-Hsiu Chu, PhD, Department of Physical Therapy, China Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2010

Primaire voltooiing (Werkelijk)

1 september 2012

Studie voltooiing (Werkelijk)

1 december 2012

Studieregistratiedata

Eerst ingediend

19 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

18 april 2014

Eerst geplaatst (Schatting)

21 april 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

21 april 2014

Laatste update ingediend die voldeed aan QC-criteria

18 april 2014

Laatst geverifieerd

1 april 2014

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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