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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Banner Alzheimer's Institute

  collaborator OTHER

• Arizona State University

  lead OTHER

Principal Investigators

• Fang Yu, PhD · Arizona State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-22

Primary Completion

2027-04-01

Completion

2028-06-30

Countries

• United States

Study Locations