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

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04299308
Collaborator
National Institute on Aging (NIA) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 arm, cross-sectional2 arm, cross-sectional
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Acute Exercise Response On Brain Imaging and Cognition
Actual Study Start Date :
Aug 28, 2020
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Behavioral: 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

Experimental: 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

Behavioral: 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

Outcome Measures

Primary Outcome Measures

  1. Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio) [Resting Vs acute exercise bout: ~1 month]

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

Secondary Outcome Measures

  1. Lactate Area Under the Curve [Resting Vs acute exercise bout: ~1 month]

    Change in circulating lactate

  2. Brain-derived neurotrophic factor (BDNF) Change [Resting Vs acute exercise bout: ~1 month]

    Change in circulating Brain Derived Neurotrophic Factor

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univeristy of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT04299308
Other Study ID Numbers:
  • STUDY00142140
  • 1R01AG062548-01A1
First Posted:
Mar 6, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021