RecruitingNot ApplicableNCT05877196

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)

Sponsor

Arizona State University

Enrollment

216 participants

Start Date

Jun 22, 2023

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment Cognitive Decline Alzheimer Disease Mild Cognitive Impairment Memory Impairment Memory Loss

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests different types of exercise programs to find the best approach for improving brain health and physical fitness in older adults with mild cognitive impairment (MCI) or early Alzheimer's disease. Participants are assigned to different exercise types based on how they respond, making this an adaptive trial design. **You may be eligible if...** - You are 65 or older - You have been diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease - You live in the community (home or assisted living) - You have been cleared by your doctor to exercise - You have a study partner (family or friend) who is in contact with you at least twice a week - You are able to safely have an MRI **You may NOT be eligible if...** - Your resting heart rate is below 50 or above 100 beats per minute - You have conditions that make exercise unsafe - You are already doing more than 150 minutes of moderate exercise per week - You are taking 2 or more antidepressants or have unstable depression or anxiety - You are already enrolled in another program aimed at improving thinking or memory Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALModerate 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.

BEHAVIORALChair-based Stretch

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

BEHAVIORALHigh-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.

BEHAVIORALCombined 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

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NCT05877196

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