Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease

NCT ID: NCT04299308

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2023-10-31

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.

Detailed Description

Aim 1: Compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (ND) elderly and AD subjects. ND (n=30) and AD (n=30) subjects will undergo a single bout of moderate intensity (45-55% HRR) or higher intensity (65-75% HRR) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). Investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in ND subjects than in AD subjects.

Aim 2: Characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in ND and AD subjects. The acute biomarker response to exercise and the effect on cognition has not been examined in aged or AD cohorts. Investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, AUC) compared to acute moderate intensity exercise, and that this response will be greater in ND than in AD subjects. Investigators further hypothesize that lactate AUC will track negatively with change in cerebral glucose metabolism and cognitive performance. Although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.

Conditions

Healthy Aging; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate Intensity Aerobic Exercise

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

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

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 Exercise

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

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Aerobic Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univeristy of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 39258961 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34051350 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01AG062548-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00142140

Identifier Type: -

Identifier Source: org_study_id