Alzheimer DiseaseBIMIINCT03035851
Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias
A study testing Aerobic exercise and Stretch and Strength in people with Alzheimer Disease and Dementia, run by University of Calgary at 1 site in Canada.
Trial summary
The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative economic burden of $800 billion by 2038. Effective prevention of dementia at a population level will need to include lifestyle factors such as promoting higher levels of physical activity. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Aerobic exercise and Stretch and Strength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inactive men and women aged 50-80 years (inclusive) with subjective cognitive symptoms but no dementia who have one or more vascular risk factors (see below) for ADRD;
- Inactivity will be assessed with a physical activity questionnaire and defined as engagement in <3 sessions/week of 20 min or more of vigorous exercise;
- Subjective cognitive symptoms will be self-reported using the MAC-Q Memory Complaint Questionnaire, recently validated as a measure of subjective memory complaints in healthy elderly subjects, in patients with mild cognitive impairment, and in relation to AD biomarkers; participants with a score of ≥25 will be considered eligible.
- Vascular risk factors for ADRD including the following:
- history of hypertension;
- diabetes mellitus;
Show all 11Show fewer
- obesity (body mass index (BMI) <40 kg/m2)
- elevated cholesterol;
- currently smoking;
- past history of coronary artery disease without recent (<5 years) symptoms.
- Participants must provide a completed PAR-Q+ form (www.csep.ca), the standard method of obtaining physician approval for participation in an exercise program. For participants without a family doctor to provide this form, we will provide information on how to find a family doctor.
Who cannot join
- diagnosis of a developmental handicap;
- history of dementia (DSM-V criteria)**;
- terminal illness (life expectancy < 1 year)
- not fluent in verbal and written English;
- history of stroke;
- currently participating in another trial;
Show all 10Show fewer
- comorbid medical or neurological illnesses (e.g., multiple sclerosis) that would confound cognitive assessments or make trial completion unlikely (in the site investigator's opinion);
- contraindication for the intervention;
- contraindication for an MRI exam.
- **Existing or suspected dementia will be identified by medical history, cognitive impairment on the Telephone Interview for Cognitive Status (TICS-modified; score≤ 20), or impaired Instrumental Activities of Daily Living (IADL) - a response of needs assistance or dependent due to cognitive impairments on any item on the Lawton scale.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Marc J Poulin
About this study
Official title: Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias: Harnessing Translational Physiology
The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative economic burden of $800 billion by 2038. Effective prevention of dementia at a population level will need to include lifestyle factors such as promoting higher levels of physical activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and cognitive decline, but the mechanisms by which physical activity exerts its protective effect on the brain remain unknown. Motivated by the need to develop strategies to prevent and treat AD and related dementias (ADRD), the investigators' overall research goal is to discover why the aging brain develops ADRD. To achieve this goal the investigators adopt a translational physiology approach (i.e., study of physiology from molecule/cell to population) to investigate how exercise improves cognitive performance, and the underlying mechanisms by which exercise prevents and/or slows down age-related declines in brain health and cognition. This approach allows the investigators to determine how physiological function is related to ADRD, with important implications for health. The investigators' prior work demonstrated a significant relationship between fitness, vascular regulation and cognition in older adults free of overt disease. These findings have implications for vascular cognitive impairment and ADRD, in which hypoperfusion and dysregulation of cerebral blood flow are thought to be important pathophysiological factors. The investigators' central hypothesis is that regular aerobic exercise mitigates age-related decreases in vascular function and cerebrovascular reserve, which in turn benefits cognition. Work by the investigators and others has provided the necessary data justifying a randomized controlled trial to evaluate the role of exercise in the prevention of ADRD.
The investigators are well equipped to undertake this trial; the investigators have dedicated institutional support and necessary expertise in vascular regulation, cognition, aging, neuroimaging and genetics.
Read more
The overall objective of this proposal is to test an exercise intervention for secondary prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD (with memory impairment symptoms but without dementia). The rationale for this trial is the urgent need for dementia prevention: an exercise intervention, which harnesses a translational physiology framework, holds such promise. The investigators will conduct this trial to determine the effects of aerobic exercise on the development of age-associated cognitive decline and dementia. The exercise intervention is designed with input from Alberta Health Services, the universal healthcare provider for Albertans, so that the intervention can be readily adopted into clinical practice if this trial is successful. The trial will address three specific aims.
SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in previously inactive older adults at increased risk of ADRD. The investigators hypothesize that participants randomized to our six-month aerobic exercise intervention will perform better on cognitive tests, compared to control participants randomized to a stretching-toning exercise group.
SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive performance after exercise training. The investigators hypothesize that exercise improves cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow, cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk scores, reflective of targeted genetic variants, moderate exercise-related cognitive and brain outcomes.
SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood flow and cerebrovascular reserve persist 12 months after participants complete a 6-month exercise training intervention. The investigators hypothesize that the effects of improved aerobic fitness will be maintained over time as a function of persistent lifestyle changes and behavioural support programs. This trial will provide evidence needed to make clinical recommendations for exercise programs in adults at risk for ADRD, with the goal of preventing dementia. Given the investigators' extensive stakeholder input, this intervention will be easily translated to other jurisdictions. This research into the mechanisms of effect for exercise will identify patient subgroups most likely to benefit, surrogate outcome markers for use in future trials to refine intervention dose/duration, and new therapeutic targets for future interventions.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Aerobic exercise, Stretch and Strength
- Keywords
- Alzheimer Disease, Dementia, Exercise, Physical Activity, Brain blood flow, Cognition, Fitness
- Medical subject headings
- Alzheimer Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Stretch and StrengthBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Participants will take part in a supervised 6-month-long aerobic (walk/jog) training program held 3 days/week. Each session will include a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions will follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cool-down, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise will increase from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity will be based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity will build from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR). Receives: Behavioral: Aerobic exercise |
| Stretch and Strength | Other | A control group will meet on a similar schedule as the exercise group for sessions on stretching and toning but without aerobic exercise. Based on prior RCTs of similar interventions the investigators expect this control to be ineffective or minimally effective, but anticipate that it will increase participant enthusiasm and retention. All assessments will be conducted in this arm. Receives: Behavioral: Stretch and Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition Assessed by Neuropsychological Test Battery
Measured: Measured at baseline, exercise intervention completion (6 months) and follow-up (18 months)
Secondary outcomes (7)
Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart
The change in aerobic fitness will be assessed by VO2max, determined by cardiopulmonary stress testing.
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Blood Biomarkers Assessed by Elisa Assays
blood sampling and analyses of the selected markers (e.g., neurotrophins, cytokines, inflammatory markers, cortisol, oxidative stress, NO and antioxidants).
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Risk/protective factors Assessed by Questionnaires
Measures include changes in dietary intake, food frequency, supplement intake, physical activity, cognitive activities, mood changes, social support and engagement.
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Brain Structure and Function Assessed by Neuroimaging Modalities
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Sleep Quality Assessed by Polysomnography, Actigraphy and Questionnaires
Measured: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Health behaviour with appropriate support strategies
The investigators will assess whether, in the 12-month period following the 6-month exercise intervention, individually-tailored, telephone support for home-based exercise improves adherence and sustains the beneficial effects of exercise.
Measured: Participants will be assessed at 6, 12 and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marc Poulin, University of Calgary
- Investigators
- Marc J Poulin, PhD, DPhil, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035851
- Sponsor's protocol ID
- REB 16-1199
- Acronym
- BIMII
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2016
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruger RL, Clark CM, Dyck AM, Anderson TJ, Clement F, Hanly PJ, Hanson HM, Hill MD, Hogan DB, Holroyd-Leduc J, Longman RS, McDonough M, Pike GB, Rawling JM, Sajobi T, Poulin MJ. The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia. Trials. 2021 Jun 14;22(1):394. doi: 10.1186/s13063-021-05336-z.
PubMed 34127029
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias: Harnessing Translational Physiology
- ClinicalTrials.gov ID
- NCT03035851
- Acronym / sponsor ID
- BIMII / REB 16-1199
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer Disease, Dementia, Exercise, Physical Activity, Brain blood flow, Cognition, Fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jan 2017 (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.
The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative economic burden of $800 billion by 2038. Effective prevention of dementia at a population level will need to include lifestyle factors such as promoting higher levels of physical activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and cognitive decline, but the mechanisms by which physical activity exerts its protective effect on the brain remain unknown. Motivated by the need to develop strategies to prevent and treat AD and related dementias (ADRD), the investigators' overall research goal is to discover why the aging brain develops ADRD. To achieve this goal the investigators adopt a translational physiology approach (i.e., study of physiology from molecule/cell to population) to investigate how exercise improves cognitive performance, and the underlying mechanisms by which exercise prevents and/or slows down age-related declines in brain health and cognition. This approach allows the investigators to determine how physiological function is related to ADRD, with important implications for health. The investigators' prior work demonstrated a significant relationship between fitness, vascular regulation and cognition in older adults free of overt disease. These findings have implications for vascular cognitive impairment and ADRD, in which hypoperfusion and dysregulation of cerebral blood flow are thought to be important pathophysiological factors. The investigators' central hypothesis is that regular aerobic exercise mitigates age-related decreases in vascular function and cerebrovascular reserve, which in turn benefits cognition. Work by the investigators and others has provided the necessary data justifying a randomized controlled trial to evaluate the role of exercise in the prevention of ADRD.
The investigators are well equipped to undertake this trial; the investigators have dedicated institutional support and necessary expertise in vascular regulation, cognition, aging, neuroimaging and genetics.
The overall objective of this proposal is to test an exercise intervention for secondary prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD (with memory impairment symptoms but without dementia). The rationale for this trial is the urgent need for dementia prevention: an exercise intervention, which harnesses a translational physiology framework, holds such promise. The investigators will conduct this trial to determine the effects of aerobic exercise on the development of age-associated cognitive decline and dementia. The exercise intervention is designed with input from Alberta Health Services, the universal healthcare provider for Albertans, so that the intervention can be readily adopted into clinical practice if this trial is successful. The trial will address three specific aims.
SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in previously inactive older adults at increased risk of ADRD. The investigators hypothesize that participants randomized to our six-month aerobic exercise intervention will perform better on cognitive tests, compared to control participants randomized to a stretching-toning exercise group.
SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive performance after exercise training. The investigators hypothesize that exercise improves cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow, cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk scores, reflective of targeted genetic variants, moderate exercise-related cognitive and brain outcomes.
SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood flow and cerebrovascular reserve persist 12 months after participants complete a 6-month exercise training intervention. The investigators hypothesize that the effects of improved aerobic fitness will be maintained over time as a function of persistent lifestyle changes and behavioural support programs. This trial will provide evidence needed to make clinical recommendations for exercise programs in adults at risk for ADRD, with the goal of preventing dementia. Given the investigators' extensive stakeholder input, this intervention will be easily translated to other jurisdictions. This research into the mechanisms of effect for exercise will identify patient subgroups most likely to benefit, surrogate outcome markers for use in future trials to refine intervention dose/duration, and new therapeutic targets for future interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseParticipants will take part in a supervised 6-month-long aerobic (walk/jog) training program held 3 days/week. Each session will include a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions will follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cool-down, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise will increase from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity will be based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity will build from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR). |
| Stretch and Strength | Other | Behavioral: Stretch and StrengthA control group will meet on a similar schedule as the exercise group for sessions on stretching and toning but without aerobic exercise. Based on prior RCTs of similar interventions the investigators expect this control to be ineffective or minimally effective, but anticipate that it will increase participant enthusiasm and retention. All assessments will be conducted in this arm. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- inactive men and women aged 50-80 years (inclusive) with subjective cognitive symptoms but no dementia who have one or more vascular risk factors (see below) for ADRD;
- Inactivity will be assessed with a physical activity questionnaire and defined as engagement in <3 sessions/week of 20 min or more of vigorous exercise;
- Subjective cognitive symptoms will be self-reported using the MAC-Q Memory Complaint Questionnaire, recently validated as a measure of subjective memory complaints in healthy elderly subjects, in patients with mild cognitive impairment, and in relation to AD biomarkers; participants with a score of ≥25 will be considered eligible.
- Vascular risk factors for ADRD including the following:
- history of hypertension;
Key exclusion criteria (10 listed)
- diagnosis of a developmental handicap;
- history of dementia (DSM-V criteria)**;
- terminal illness (life expectancy < 1 year)
- not fluent in verbal and written English;
- history of stroke;
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 |
|---|---|---|
| Aerobic exercise | Behavioural | Aerobic exercise |
| Stretch and Strength | Behavioural | Stretch and Strength |
Primary outcome
Change in Cognition Assessed by Neuropsychological Test Battery
Time frame: Measured at baseline, exercise intervention completion (6 months) and follow-up (18 months)
7 secondary outcomes
Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Blood Biomarkers Assessed by Elisa Assays
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Risk/protective factors Assessed by Questionnaires
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Brain Structure and Function Assessed by Neuroimaging Modalities
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Sleep Quality Assessed by Polysomnography, Actigraphy and Questionnaires
Time frame: Participants will be assessed at baseline, at the completion of the intervention (6 months) and at follow-up (18 months) phases of the study.
Change in Health behaviour with appropriate support strategies
Time frame: Participants will be assessed at 6, 12 and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 34127029Kruger RL, Clark CM, Dyck AM, Anderson TJ, Clement F, Hanly PJ, Hanson HM, Hill MD, Hogan DB, Holroyd-Leduc J, Longman RS, McDonough M, Pike GB, Rawling JM, Sajobi T, Poulin MJ. The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia. Trials. 2021 Jun 14;22(1):394. doi: 10.1186/s13063-021-05336-z.
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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.
Marc J Poulin, PhD, DPhil principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Stretch and Strength in people with Alzheimer Disease and Dementia, run by University of Calgary 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 10 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc J Poulin, PhD, DPhil (403-220-8372, poulin@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognition Assessed by Neuropsychological Test Battery (time frame: Measured at baseline, exercise intervention completion (6 months) and follow-up (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035851, which also lists 1 linked publication.
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 29 Apr 2026.