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

Inclusion Criteria13

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 Criteria11

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

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.