RecruitingNot Applicable

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

United States216 participantsStarted 2023-06-22

Plain-language summary

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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Peak oxygen consumption

Timeframe: measured at 0 and 6 months

White Matter Hyperintensity volume

Timeframe: measured at 0 and 6 months

Trial details

NCT IDNCT05877196

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Kristi Spieleder, MS

480-884-2765 kspieled@asu.edu