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Exercise for Brain Health in the Fight Against Alzheimer's Disease

Primary Purpose

Healthy Cognition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Flexibility Control
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Cognition focused on measuring Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland, Department of KinesiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Training

Flexibility Control

Arm Description

Group exercise and treadmill walking

Group exercise and flexibility exercise

Outcomes

Primary Outcome Measures

Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5
Change from Baseline to 6 months in Resting Cerebral Blood Flow

Secondary Outcome Measures

Change from Baseline to 6 months in VO2peak
Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness
Change from Baseline to 6 months in 6 Minute Walk Test
Distance walked in 6 minutes

Full Information

First Posted
October 26, 2018
Last Updated
November 14, 2022
Sponsor
University of Maryland, College Park
Collaborators
National Institute on Aging (NIA), Johns Hopkins University, Marquette University, University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03727360
Brief Title
Exercise for Brain Health in the Fight Against Alzheimer's Disease
Official Title
Exercise for Brain Health in the Fight Against Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
National Institute on Aging (NIA), Johns Hopkins University, Marquette University, University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Cognition
Keywords
Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
Group exercise and treadmill walking
Arm Title
Flexibility Control
Arm Type
Active Comparator
Arm Description
Group exercise and flexibility exercise
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
Supervised exercise conducted four days per week for six months.
Intervention Type
Other
Intervention Name(s)
Flexibility Control
Intervention Description
Supervised exercise conducted four days per week for six months.
Primary Outcome Measure Information:
Title
Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5
Time Frame
Baseline and 6 months
Title
Change from Baseline to 6 months in Resting Cerebral Blood Flow
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline to 6 months in VO2peak
Description
Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness
Time Frame
Baseline and 6 months
Title
Change from Baseline to 6 months in 6 Minute Walk Test
Description
Distance walked in 6 minutes
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
301-405-2574
Email
exercisebrainhealth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Carson Smith, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Department of Kinesiology
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
301-405-2574
Email
exercisebrainhealth@gmail.com

12. IPD Sharing Statement

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Exercise for Brain Health in the Fight Against Alzheimer's Disease

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