Dementia Risk and Dynamic Response to Exercise
DYNAMIC
2 other identifiers
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2021
CompletedResults Posted
Study results publicly available
May 3, 2022
CompletedMay 3, 2022
May 1, 2022
2 years
July 2, 2019
February 9, 2022
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral Blood Flow Area Under Curve
Cumulative cerebral blood flow measured by Arterial Spin Labeling MRI. The standard arterial spin labeling unit of measure is average milliliters per 100 grams of tissue per minute (mL/100g tissue/minute). For the present analysis, we summed perfusion over the entire acquisition period, 23.2 minutes, rather than averaging. Therefore the units are milliliters per 100 grams of tissue
~24 minutes
Secondary Outcomes (3)
Insulin-like Growth Factor-1 Change
Pre-to-post intervention (~15 minutes)
Vascular Endothelial Growth Factor Change
Pre-to-post intervention (~15 minutes)
Brain Derived Neurotrophic Factor Change
Pre-to-post intervention (~15 minutes)
Study Arms (2)
Exercise - apolipoprotein e4 carrier
EXPERIMENTALA single 15 minute bout of moderate intensity aerobic exercise for individuals with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
Exercise - apolipoprotein e4 non-carrier
EXPERIMENTALA single 15 minute bout of moderate intensity aerobic exercise for individuals with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 65-85
- English speaking
- Normal or corrected hearing or vision,
- Without activity restrictions.
You may not qualify if:
- Clinically significant cognitive or psychiatric illness,
- Anti- coagulant use,
- High cardiovascular risk without physician clearance for exercise,
- Exercise-limiting musculoskeletal condition,
- MRI contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Alzheimer's Disease Center
Fairway, Kansas, 66205, United States
Related Publications (2)
Vidoni ED, Morris JK, Palmer JA, Li Y, White D, Kueck PJ, John CS, Honea RA, Lepping RJ, Lee P, Mahnken JD, Martin LE, Billinger SA. Dementia risk and dynamic response to exercise: A non-randomized clinical trial. PLoS One. 2022 Jul 8;17(7):e0265860. doi: 10.1371/journal.pone.0265860. eCollection 2022.
PMID: 35802628DERIVEDWhite D, John CS, Kucera A, Truver B, Lepping RJ, Kueck PJ, Lee P, Martin L, Billinger SA, Burns JM, Morris JK, Vidoni ED. A methodology for an acute exercise clinical trial called dementia risk and dynamic response to exercise. Sci Rep. 2021 Jun 17;11(1):12776. doi: 10.1038/s41598-021-92177-0.
PMID: 34140586DERIVED
Results Point of Contact
- Title
- Dr. Eric Vidoni
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Eric D Vidoni, PT, PHD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
October 25, 2019
Primary Completion
October 28, 2021
Study Completion
October 28, 2021
Last Updated
May 3, 2022
Results First Posted
May 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.