Alzheimer's DiseaseNCT01935024
Benefits of Exercise in Alzheimer's Disease
A study testing Personalized Exercise Regimen in people with Alzheimer's Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Personalized Exercise Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2013to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to tolerate MRI
- Ability to speak and understand the English language (as questionnaires and tests are only available in English)
- 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
Who cannot join
- 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)
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital, WW5-449
Toronto, Ontario, M5T 2S8
Carmela Tartaglia, MD, FRCPC, 416-603-5483, carmela.tartaglia@uhn.ca
Cassandra J. Anor, BSc 2015, 416-507-6880, cassandra.anor@uhn.ca
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Personalized Exercise Regimen
- Keywords
- Alzheimer's disease, dementia, aerobic exercise
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Exercise RegimenOther
All exercise regimens include a stationary bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Normal Activity level | No intervention | Not described |
| Personalized Exercise Regimen | Active comparator | Not described Receives: Other: Personalized Exercise Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout first 6 months of patient participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start1 Aug 2013
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Carmela Tartaglia, MD, FRCPC, Principal investigator, Cognitive Neurologist at the Toronto Western Hospital Memory Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935024
- Sponsor's protocol ID
- 12-5749-AE
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Benefits of an Outpatient Aerobic Activity Program in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01935024
- Acronym / sponsor ID
- 12-5749-AE
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, dementia, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Activity level | No intervention | – |
| Personalized Exercise Regimen | Active comparator | Other: Personalized Exercise Regimen |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Exercise RegimenAll exercise regimens include a stationary bicycle. | Other | Personalized Exercise Regimen |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmela Tartaglia, MD, FRCPC principal investigator
Cognitive Neurologist at the Toronto Western Hospital Memory Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Exercise Regimen in people with Alzheimer's Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmela Tartaglia, MD, FRCPC (416-603-5483, carmela.tartaglia@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Test Battery (time frame: Throughout first 6 months of patient participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.