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A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses

RecruitingNAAges 65 Years - anyAllArizona State University
NCT05877196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test 6 months of aerobic exercise in older adults who are 65 years or older and have mild cognitive impairment (MCI) or probable/possible mild Alzheimer's Disease. The main questions it aims to answer are: * test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; * identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and * examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.

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📋 Eligibility rules (as published)
Inclusion Criteria: Participants: * Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria. * Community-dwelling, e.g., homes and assisted living * Age 65 years and older * Medical clearance from PCP or cardiovascular provider * Have a qualified study partner * Agree to the blood draws * Verified MRI safety Study Partner: * Age 18 or older * Contact with participant ≥ 2 times per week for ≥ 6 months * Know the participant's memory status and ability to perform activities of daily living * Consent to participant Exclusion Criteria: Participants * Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting * American College of Sports Medicine contraindications to exercise * New, unevaluated symptoms or diseases a healthcare provider has not evaluated * Abnormal cardiac condition uncovered during VO2peak testing * Enrollment in another intervention that aims at improving cognition * Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months * ≥ 2 anti-depression medications, or poorly managed or unstable depression * Poorly managed or unstable anxiety Study partners: * none
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What it tests

  • Moderate Intensity Continuous Training (MICT)
  • Chair-based Stretch
  • High-Intensity Interval Training (HIIT)
  • Combined Aerobic Resistance Exercise (CARE)
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Where

1 site
Arizona State University
Phoenix, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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