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Dementia Risk and Dynamic Response to Exercise (DYNAMIC)

Study Description
Brief Summary:
Research suggests that physical exercise supports brain health and cognition as we age. The goal of this project is to examine the specific changes in brain blood flow and biological factors in the blood immediately after exercise in older adults who have the APOE4 gene, a genetic risk factor for developing Alzheimer's. Results from this study will help researchers and clinicians understand and measure changes in the body and brain as a function of exercise, and how those changes relate to Alzheimer's risk.

Condition or disease Intervention/treatment Phase
Alzheimer Disease 2 Due to Apoe4 Isoform Healthy Aging Behavioral: Moderate Intensity Aerobic Exercise Not Applicable

Detailed Description:
The brain and cardiovascular system share common risk factors for age-related diseases such as hypertension, hypercholesterolemia, and genetics (e.g. APOE4). Because of this link, much work has focused on the role of cerebrovascular health in reducing dementia risk. Regular aerobic exercise has well-established benefits for cardiovascular health and has been repeatedly linked to better cognition, brain health, and lower risk of Alzheimer's disease (AD). Despite strong evidence for sustained cognitive and brain outcomes, the mechanisms relating aerobic exercise with brain health and cognition remain imprecisely defined. Amongst many potential mechanisms, cerebral blood flow (CBF) and blood-based biomarkers, such as neurotrophins, are promising targets for their shared association to brain and cardiovascular health. Prior investigations have largely attempted to measure change in these mechanisms under resting conditions after an extended exercise intervention with mixed and conflicting results. Further, studies have often not accounted for genetic differences that may blunt the effect of exercise. Unlike prior work, our innovative approach is to begin by characterizing the dynamic changes that result from an acute exercise challenge. A single bout of aerobic exercise temporarily increases CBF and prompts neurotrophin release. These transient changes ultimately drive long-term physiologic adaptation to exercise. Therefore, the study team will characterize the dynamic response to an acute, standardized bout of aerobic exercise in a group of nondemented older adults, comparing those who do and do not carry the APOE4 allele. The first aim will test if CBF response to an acute exercise challenge is blunted in APOE4 carriers. The second aim will similarly test the acute exercise response of blood-based biomarkers such as brain derived neurotrophic factor, insulin-like growth factor, and vascular endothelial growth factor in APOE4 carriers versus non-carriers. The study team expects that more accurately understanding the acute effects will provide valuable insight into how aerobic exercise supports cognitive function and brain health. Armed with this knowledge the field can optimize biomarker measurement for future exercise intervention randomized controlled trials, informing our long-term goal of identifying precision exercise prescription for AD prevention.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, single visit, case-control study identified as an intervention due to the use of a single bout of aerobic exercise under NIH rules (https://grants.nih.gov/policy/clinical-trials/definition.htm)
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dementia Risk and Dynamic Response to Exercise
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Exercise
A single 15 minute bout of moderate intensity aerobic exercise.
 Behavioral: Moderate Intensity Aerobic Exercise
Participants will exercise for 15 minutes in a moderate age-predicted heart rate range. The study team will employ an exercise device such as a treadmill, cycle, or recumbent stepper to maintain control over workload.
Outcome Measures
Primary Outcome Measures :
  1. CBF Area Under Curve [ Time Frame: ~24 minutes ]
    Cumulative cerebral blood flow measured by Arterial Spin Labeling MRI


Secondary Outcome Measures :
  1. Insulin-like Growth Factor-1 Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating IGF-1 (Insulin-like Growth Factor-1) from pre-to-post exercise

  2. Vascular Endothelial Growth Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating VEGF (Vascular Endothelial Growth Factor) from pre-to-post exercise

  3. Brain Derived Neurotrophic Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating BDNF (Brain Derived Neurotrophic Factor) from pre-to-post exercise


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 65-85
  • English speaking
  • Normal or corrected hearing or vision,
  • Without activity restrictions.

Exclusion Criteria:

  • Clinically significant cognitive or psychiatric illness,
  • Anti- coagulant use,
  • High cardiovascular risk without physician clearance for exercise,
  • Exercise-limiting musculoskeletal condition,
  • MRI contraindications
Contacts and Locations

Locations
Layout table for location information
United States, Kansas
University of Kansas Alzheimer's Disease Center
Fairway, Kansas, United States, 66205
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Eric D Vidoni, PT, PHD University of Kansas Medical Center
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE October 25, 2019
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019) 		CBF Area Under Curve [ Time Frame: ~24 minutes ]
Cumulative cerebral blood flow measured by Arterial Spin Labeling MRI
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		CBF Area Under Curve [ Time Frame: 24 minutes ]
Cumulative cerebral blood flow measured by Arterial Spin Labeling MRI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Insulin-like Growth Factor-1 Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating IGF-1 (Insulin-like Growth Factor-1) from pre-to-post exercise
  • Vascular Endothelial Growth Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating VEGF (Vascular Endothelial Growth Factor) from pre-to-post exercise
  • Brain Derived Neurotrophic Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating BDNF (Brain Derived Neurotrophic Factor) from pre-to-post exercise
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Insulin-like Growth Factor-1 Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating IGF-1 from pre-to-post exercise
  • Vascular Endothelial Growth Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating VEGF from pre-to-post exercise
  • Brain Derived Neurotrophic Factor Change [ Time Frame: Pre-to-post intervention (~15 minutes) ]
    Change in circulating BDNF from pre-to-post exercise
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dementia Risk and Dynamic Response to Exercise
Official Title  ICMJE Dementia Risk and Dynamic Response to Exercise
Brief Summary Research suggests that physical exercise supports brain health and cognition as we age. The goal of this project is to examine the specific changes in brain blood flow and biological factors in the blood immediately after exercise in older adults who have the APOE4 gene, a genetic risk factor for developing Alzheimer's. Results from this study will help researchers and clinicians understand and measure changes in the body and brain as a function of exercise, and how those changes relate to Alzheimer's risk.
Detailed Description The brain and cardiovascular system share common risk factors for age-related diseases such as hypertension, hypercholesterolemia, and genetics (e.g. APOE4). Because of this link, much work has focused on the role of cerebrovascular health in reducing dementia risk. Regular aerobic exercise has well-established benefits for cardiovascular health and has been repeatedly linked to better cognition, brain health, and lower risk of Alzheimer's disease (AD). Despite strong evidence for sustained cognitive and brain outcomes, the mechanisms relating aerobic exercise with brain health and cognition remain imprecisely defined. Amongst many potential mechanisms, cerebral blood flow (CBF) and blood-based biomarkers, such as neurotrophins, are promising targets for their shared association to brain and cardiovascular health. Prior investigations have largely attempted to measure change in these mechanisms under resting conditions after an extended exercise intervention with mixed and conflicting results. Further, studies have often not accounted for genetic differences that may blunt the effect of exercise. Unlike prior work, our innovative approach is to begin by characterizing the dynamic changes that result from an acute exercise challenge. A single bout of aerobic exercise temporarily increases CBF and prompts neurotrophin release. These transient changes ultimately drive long-term physiologic adaptation to exercise. Therefore, the study team will characterize the dynamic response to an acute, standardized bout of aerobic exercise in a group of nondemented older adults, comparing those who do and do not carry the APOE4 allele. The first aim will test if CBF response to an acute exercise challenge is blunted in APOE4 carriers. The second aim will similarly test the acute exercise response of blood-based biomarkers such as brain derived neurotrophic factor, insulin-like growth factor, and vascular endothelial growth factor in APOE4 carriers versus non-carriers. The study team expects that more accurately understanding the acute effects will provide valuable insight into how aerobic exercise supports cognitive function and brain health. Armed with this knowledge the field can optimize biomarker measurement for future exercise intervention randomized controlled trials, informing our long-term goal of identifying precision exercise prescription for AD prevention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm, single visit, case-control study identified as an intervention due to the use of a single bout of aerobic exercise under NIH rules (https://grants.nih.gov/policy/clinical-trials/definition.htm)
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Alzheimer Disease 2 Due to Apoe4 Isoform
  • Healthy Aging
Intervention  ICMJE Behavioral: Moderate Intensity Aerobic Exercise
Participants will exercise for 15 minutes in a moderate age-predicted heart rate range. The study team will employ an exercise device such as a treadmill, cycle, or recumbent stepper to maintain control over workload.
Study Arms  ICMJE Experimental: Exercise
A single 15 minute bout of moderate intensity aerobic exercise.
Intervention: Behavioral: Moderate Intensity Aerobic Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65-85
  • English speaking
  • Normal or corrected hearing or vision,
  • Without activity restrictions.

Exclusion Criteria:

  • Clinically significant cognitive or psychiatric illness,
  • Anti- coagulant use,
  • High cardiovascular risk without physician clearance for exercise,
  • Exercise-limiting musculoskeletal condition,
  • MRI contraindications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009629
Other Study ID Numbers  ICMJE STUDY00142822
R21AG061548 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with unaffiliated investigators after completion of data collection and a reasonable amount of analysis and dissemination time. Contact the PI for further information.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Following a reasonable amount of analysis and dissemination time, the data will be available via request.
Access Criteria: Following institutional limits and recommendations and subject to use agreements.
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Eric D Vidoni, PT, PHD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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