Benefits of Exercise in Alzheimer's Disease

September 24, 2019 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital, WW5-449
        • Principal Investigator:
          • Carmela Tartaglia, MD, FRCPC
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mary Pat McAndrews, PhD
        • Sub-Investigator:
          • Alison Lake, MSc, OT
        • Sub-Investigator:
          • Mallar Chakravarty, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal Activity level
Active Comparator: Personalized Exercise Regimen
Other: Personalized Exercise Regimen
All exercise regimens include a stationary bicycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological Test Battery
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-5749-AE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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