- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03727360
Exercise for Brain Health in the Fight Against Alzheimer's Disease
December 20, 2023 updated by: University of Maryland, College Park
The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80).
Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD).
Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC).
The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus.
The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Coordinator
- Phone Number: 301-405-2574
- Email: exercisebrainhealth@gmail.com
Study Locations
-
-
Maryland
-
College Park, Maryland, United States, 20742
- Recruiting
- University of Maryland, Department of Kinesiology
-
Contact:
- Study Coordinator
- Phone Number: 301-405-2574
- Email: exercisebrainhealth@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 60 to 80 years old
- Fluent in English
- Willingness to make the time commitment to participate in the project, including randomization to treatments
- Physically inactive (physical activity not more than 2 days per week for the past 6 months)
- Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
- Determined to be safe for MRI
Exclusion Criteria:
- Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
- Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
- Untreated severe major depression
- Substance abuse or dependence
- Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
- Use of acetylcholinesterase inhibitors (e.g., Aricept)
- Unstable or severe cardiovascular disease or asthmatic condition
- History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
- Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Training
Group exercise and treadmill walking
|
Supervised exercise conducted four days per week for six months.
|
Active Comparator: Flexibility Control
Group exercise and flexibility exercise
|
Supervised exercise conducted four days per week for six months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Change from Baseline to 6 months in Resting Cerebral Blood Flow
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to 6 months in VO2peak
Time Frame: Baseline and 6 months
|
Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness
|
Baseline and 6 months
|
Change from Baseline to 6 months in 6 Minute Walk Test
Time Frame: Baseline and 6 months
|
Distance walked in 6 minutes
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: J. Carson Smith, PhD, University of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2018
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
October 26, 2018
First Submitted That Met QC Criteria
October 30, 2018
First Posted (Actual)
November 1, 2018
Study Record Updates
Last Update Posted (Estimated)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 20, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1115946
- 1R01AG057552 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Cognition
-
Amsterdam UMC, location VUmcRecruitingHealthy CognitionNetherlands
-
San Diego State UniversityActive, not recruitingHealthy Aging | Cognition | Cardiometabolic HealthUnited States
-
Lawson Health Research InstituteNot yet recruitingExercise | Diet, Healthy | Lifestyle, Healthy | Cognition Disorders in Old Age
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
PharmanexClinical Research AustraliaRecruiting
-
Rutgers, The State University of New JerseyCompleted
-
University of PennsylvaniaRecruiting
-
LifeSeasons Inc.KGK Science Inc.Completed
-
Université de SherbrookeCompleted
-
Barcelonabeta Brain Research Center, Pasqual Maragall...Hoffmann-La Roche; Hospital Clinic of BarcelonaEnrolling by invitationHealthy | Mild Cognitive ImpairmentSpain
Clinical Trials on Exercise Training
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Universita di VeronaRecruiting
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway
-
Hacettepe UniversityCompleted