RECRUITINGINTERVENTIONAL

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

Precision Medicine in Alzheimer's Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-Fitness Responses (The FIT-AD SMART Trial)

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Moderate Intensity Continuous Training (MICT)

Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.

BEHAVIORAL

Chair-based Stretch

Stretching while seated for 30-50 minutes, 3 times per week for 6 months.

BEHAVIORAL

High-Intensity Interval Training (HIIT)

Aerobic cycling at a vigorous intensity (80-90% of heart rate reserve 4-minute bouts with 4-minute recovery intervals) for 40 minutes, 3 times per week for 3 months.

BEHAVIORAL

Combined Aerobic Resistance Exercise (CARE)

6 full-body strength-building exercises followed by 30 minutes of MICT cycling (described above). Total duration is 60 minutes, 3 times per week for 3 months.

Locations (1)

Arizona State University

Phoenix, Arizona, United States