Benefits of Exercise in Alzheimer's Disease
24 september 2019 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Ontario
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Toronto, Ontario, Kanada, M5T 2S8
- Rekrytering
- Toronto Western Hospital, WW5-449
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Huvudutredare:
- Carmela Tartaglia, MD, FRCPC
-
Kontakt:
- Carmela Tartaglia, MD, FRCPC
- Telefonnummer: 416-603-5483
- E-post: carmela.tartaglia@uhn.ca
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Kontakt:
- Cassandra J. Anor, BSc 2015
- Telefonnummer: 416-507-6880
- E-post: cassandra.anor@uhn.ca
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Underutredare:
- Mary Pat McAndrews, PhD
-
Underutredare:
- Alison Lake, MSc, OT
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Underutredare:
- Mallar Chakravarty, PhD
-
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år till 95 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria for patients will be as follows:
- Diagnosis of probable Alzheimer's disease as per 2011 criteria
- 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)
- Age 60 to 95 inclusive
- Mobility, preserved vision and hearing (eyeglasses and/or hearing aid are permissible) sufficient for compliance with testing procedures
- 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)
- Presence of a respective caregiver
- Ability to tolerate MRI
- 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:
- Being the primary caregiver for a given patient
- Ability to speak and understand English (as questionnaires and tests are only available in English)
- MoCA score ≥ 26
Exclusion criteria for Patients and Caregivers:
- History of another neurological disorder
- Psychiatric disorder
- Severe aphasia (semantic word loss)
- 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)
- Hearing problems requiring correction beyond hearing aids (videos have an auditory component)
Exclusion Criteria for Patients:
- 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
- Inability to tolerate or perform aerobic exercise as declared by family physician on PARmed-X form
- Significant vascular disease seen on MRI (Fazekas score>2)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Normal Activity level
|
|
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Aktiv komparator: Personalized Exercise Regimen
|
All exercise regimens include a stationary bicycle.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neuropsychological Test Battery
Tidsram: 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.
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Throughout first 6 months of patient participation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Carmela Tartaglia, MD, FRCPC, Cognitive Neurologist at the Toronto Western Hospital Memory Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2013
Primärt slutförande (Förväntat)
1 april 2020
Avslutad studie (Förväntat)
1 april 2020
Studieregistreringsdatum
Först inskickad
23 augusti 2013
Först inskickad som uppfyllde QC-kriterierna
29 augusti 2013
Första postat (Uppskatta)
4 september 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 september 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 september 2019
Senast verifierad
1 september 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-5749-AE
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .