NCT04299308

Brief Summary

The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

March 4, 2020

Results QC Date

May 9, 2025

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio)

    FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI).

    Resting Vs acute exercise bout: ~1 month

Secondary Outcomes (2)

  • Lactate Area Under the Curve

    Resting Vs acute exercise bout: ~1 month

  • Brain-derived Neurotrophic Factor (BDNF) Change

    Resting Vs acute exercise bout: ~1 month

Study Arms (2)

Moderate Intensity Aerobic Exercise

EXPERIMENTAL

45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR

Behavioral: Aerobic Exercise

High Intensity Aerobic Exercise

EXPERIMENTAL

65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR

Behavioral: Aerobic Exercise

Interventions

Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload

High Intensity Aerobic ExerciseModerate Intensity Aerobic Exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 and older
  • Stable medication doses (\>1month)
  • Post-menopausal
  • Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)

You may not qualify if:

  • Inability to provide consent
  • Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus
  • Recent ischemic heart disease (\<2 years)
  • Diagnosis of an clinically significant chronic disease including cardiovascular disease (CVD), other metabolic diseases (e.g., thyroid), cancer, human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome
  • Excluded from or unable to complete an MRI scan
  • Any Neurological disorders that have the potential to impair cognition or brain metabolism (e.g., Parkinson's disease, stroke defined as a clinical episode with neuroimaging evidence in an appropriate area to explain the symptoms).
  • Clinically significant depressive symptoms that may impair cognition, abnormalities in B12, rapid plasma regain (RPR), or thyroid function that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Green ZD, John CS, Kueck PJ, Blankenship AE, Kemna RE, Johnson CN, Yoksh LE, Best SR, Donald JS, Mahnken JD, Burns JM, Vidoni ED, Morris JK. Acute exercise alters brain glucose metabolism in aging and Alzheimer's disease. J Physiol. 2024 Sep 11:10.1113/JP286923. doi: 10.1113/JP286923. Online ahead of print.

    PMID: 39258961BACKGROUND
  • Green ZD, John CS, Kueck PJ, Burns JM, Perry M, Donald J, Mahnken JD, Honea RA, Vidoni ED, Morris JK. Rationale and methods to characterize the acute exercise response in aging and Alzheimer's Disease: the AEROBIC pilot study. Contemp Clin Trials. 2021 Aug;107:106457. doi: 10.1016/j.cct.2021.106457. Epub 2021 May 27.

    PMID: 34051350BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Jill Morris
Organization
University of Kansas Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 2 arm, cross-sectional
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

August 28, 2020

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

July 23, 2025

Results First Posted

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations