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Benefits of Exercise in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Personalized Exercise Regimen

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, dementia, aerobic exercise

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Toronto Western Hospital, WW5-449Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Normal Activity level

Personalized Exercise Regimen

Arm Description

Outcomes

Primary Outcome Measures

Neuropsychological Test Battery

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01935024

First Posted

August 23, 2013

Last Updated

September 24, 2019

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01935024

Brief Title

Benefits of Exercise in Alzheimer's Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2013 (Actual)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's disease, dementia, aerobic exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal Activity level

Arm Type

No Intervention

Arm Title

Personalized Exercise Regimen

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Personalized Exercise Regimen

Intervention Description

All exercise regimens include a stationary bicycle.

Primary Outcome Measure Information:

Title

Neuropsychological Test Battery

Description

Time Frame

Throughout first 6 months of patient participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carmela Tartaglia, MD, FRCPC

Phone

416-603-5483

carmela.tartaglia@uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmela Tartaglia, MD, FRCPC

Organizational Affiliation

Cognitive Neurologist at the Toronto Western Hospital Memory Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Western Hospital, WW5-449

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carmela Tartaglia, MD, FRCPC

Phone

416-603-5483

carmela.tartaglia@uhn.ca

First Name & Middle Initial & Last Name & Degree

Cassandra J. Anor, BSc 2015

Phone

416-507-6880

cassandra.anor@uhn.ca

First Name & Middle Initial & Last Name & Degree

Carmela Tartaglia, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Mary Pat McAndrews, PhD

First Name & Middle Initial & Last Name & Degree

Alison Lake, MSc, OT

First Name & Middle Initial & Last Name & Degree

Mallar Chakravarty, PhD

12. IPD Sharing Statement

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Benefits of Exercise in Alzheimer's Disease

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