Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Benefits of Exercise in Alzheimer's Disease

24. september 2019 opdateret af: Carmela Tartaglia, University Health Network, Toronto

Assessing the Benefits of an Outpatient Aerobic Activity Program in Patients With Alzheimer's Disease

Exercise has been shown to be beneficial for the brain. The investigators would like to test this specifically for those diagnosed with Alzheimer's disease. This study will involve 30 randomized patients to take part in the out-patient exercise program and 30 patients to continue with their regular activities over a 6-month period. Once that period is over, half of the 30 patients who participated in the outpatient exercise program will continue in the program and the other half will be randomized to independently continue to exercise. The investigators hypothesize that exercising will benefit the patient by slowing the dementia process, improving behavioral symptoms, and decreasing volume loss of certain brain regions. Each person will perform personalized exercise regimens, MR imaging and neuropsychological tests will be used to measure the benefits of exercise. Ultimately, the hope is that the results of this study could be used to facilitate exercise programs for patients. Enrollment is completely voluntary and all personal data obtained will remain confidential.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Rekruttering
        • Toronto Western Hospital, WW5-449
        • Ledende efterforsker:
          • Carmela Tartaglia, MD, FRCPC
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Mary Pat McAndrews, PhD
        • Underforsker:
          • Alison Lake, MSc, OT
        • Underforsker:
          • Mallar Chakravarty, PhD

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

60 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria for patients will be as follows:

  1. Diagnosis of probable Alzheimer's disease as per 2011 criteria
  2. Mild or moderate stage of dementia, a score of 10-25 in the Clinical dementia rating score (CDR) <2 and a score of 10-25 (inclusive) on the Montreal Cognitive Assessment (MoCA)
  3. Age 60 to 95 inclusive
  4. Mobility, preserved vision and hearing (eyeglasses and/or hearing aid are permissible) sufficient for compliance with testing procedures
  5. Ability to tolerate and perform aerobic exercise program (as per The Canadian Society for Exercise Physiology; all patients above the age of 69 embarking on a new exercise routine should have the "Physical Activity Readiness Medical Examination" (PARmed-X) form completed by their family physician. All patients being asked to enroll in the study will have their PCPs fill out this form to ensure the patient is able to withstand the exercise program. If they are being followed by a cardiologist, they fill out the form)
  6. Presence of a respective caregiver
  7. Ability to tolerate MRI
  8. Ability to speak and understand the English language (as questionnaires and tests are only available in English)

Inclusion criteria for the caregivers will be as follows:

  1. Being the primary caregiver for a given patient
  2. Ability to speak and understand English (as questionnaires and tests are only available in English)
  3. MoCA score ≥ 26

Exclusion criteria for Patients and Caregivers:

  1. History of another neurological disorder
  2. Psychiatric disorder
  3. Severe aphasia (semantic word loss)
  4. Visual deficits requiring correction beyond the use of eyeglasses or contact lenses (intact visual acuity is required for completing both the questionnaires and the emotion evaluation test which consists of video vignettes)
  5. Hearing problems requiring correction beyond hearing aids (videos have an auditory component)

Exclusion Criteria for Patients:

  1. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal pieces or objects in the eyes, skin or body will be excluded as they will be unable to have a MRI scan
  2. Inability to tolerate or perform aerobic exercise as declared by family physician on PARmed-X form
  3. Significant vascular disease seen on MRI (Fazekas score>2)

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Normal Activity level
Aktiv komparator: Personalized Exercise Regimen
Andet: Personalized Exercise Regimen
All exercise regimens include a stationary bicycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neuropsychological Test Battery
Tidsramme: Throughout first 6 months of patient participation
The test battery selected comprises of standardized, validated tests focusing on domains including: attention & concentration, executive functioning, learning and memory, visuospatial, language and semantic memory, pre-morbid intellectual functioning, and speed of processing.
Throughout first 6 months of patient participation

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

Efterforskere

  • Ledende efterforsker: Carmela Tartaglia, MD, FRCPC, Cognitive Neurologist at the Toronto Western Hospital Memory Clinic

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 (Faktiske)

1. august 2013

Primær færdiggørelse (Forventet)

1. april 2020

Studieafslutning (Forventet)

1. april 2020

Datoer for studieregistrering

Først indsendt

23. august 2013

Først indsendt, der opfyldte QC-kriterier

29. august 2013

Først opslået (Skøn)

4. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12-5749-AE

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 .

Kliniske forsøg med Personalized Exercise Regimen

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner