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Benefits of Exercise in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01935024
Recruitment Status : Recruiting
First Posted : September 4, 2013
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Carmela Tartaglia, University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Personalized Exercise Regimen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Benefits of an Outpatient Aerobic Activity Program in Patients With Alzheimer's Disease
Actual Study Start Date : August 1, 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935024


Contacts
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Contact: Carmela Tartaglia, MD, FRCPC 416-603-5483 carmela.tartaglia@uhn.ca

Locations
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Canada, Ontario
Toronto Western Hospital, WW5-449 Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Carmela Tartaglia, MD, FRCPC    416-603-5483    carmela.tartaglia@uhn.ca   
Contact: Cassandra J. Anor, BSc 2015    416-507-6880    cassandra.anor@uhn.ca   
Principal Investigator: Carmela Tartaglia, MD, FRCPC         
Sub-Investigator: Mary Pat McAndrews, PhD         
Sub-Investigator: Alison Lake, MSc, OT         
Sub-Investigator: Mallar Chakravarty, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Carmela Tartaglia, MD, FRCPC Cognitive Neurologist at the Toronto Western Hospital Memory Clinic

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Responsible Party: Carmela Tartaglia, MD, FRCPC, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01935024    
Other Study ID Numbers: 12-5749-AE
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Carmela Tartaglia, University Health Network, Toronto:
Alzheimer's disease
dementia
aerobic exercise
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders