Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
NCT05877196

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

Led by Arizona State University · Updated on 2026-05-05

216

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

Sponsors

A

Arizona State University

Lead Sponsor

B

Banner Alzheimer's Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of mild cognitive impairment or probable/possible mild Alzheimer's disease dementia according to 2011 Alzheimer's association-NIA criteria
  • Community-dwelling, such as living at home or in assisted living
  • Age 65 years and older
  • Medical clearance from primary care provider or cardiovascular specialist
  • Have a qualified study partner
  • Agree to blood draws
  • Verified safe for MRI scanning
  • Study partner aged 18 or older
  • Study partner has contact with participant at least twice per week for 6 months or more
  • Study partner knows participant's memory status and daily living abilities
  • Study partner consents to participant's involvement
Not Eligible

You will not qualify if you...

  • Resting heart rate less than or equal to 50 or greater than or equal to 100 beats per minute after 5 minutes of quiet resting
  • American College of Sports Medicine contraindications to exercise
  • New or unevaluated symptoms or diseases not yet assessed by a healthcare provider
  • Abnormal cardiac condition found during VO2peak testing
  • Currently enrolled in another intervention aiming to improve cognition
  • Moderate to strenuous exercise 150 minutes or more per week in the past 6 months
  • Taking two or more anti-depression medications or having poorly managed or unstable depression
  • Poorly managed or unstable anxiety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Arizona State University

Phoenix, Arizona, United States, 85004

Actively Recruiting

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Research Team

K

Kristi Spieleder, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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