NCT05877196: SMART

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

Recruiting now NA Last updated 22 April 2025

What this trial tests

NA trial testing Moderate Intensity Continuous Training (MICT) in Mild Cognitive Impairment in 216 participants. Currently enrolling.

Timeline

22 June 2023

Primary endpoint
1 April 2027

30 June 2028

Quick facts

Lead sponsor	Arizona State University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	216
Start date	22 June 2023
Primary completion	1 April 2027
Estimated completion	30 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Moderate Intensity Continuous Training (MICT)
• Chair-based Stretch
• High-Intensity Interval Training (HIIT)
• Combined Aerobic Resistance Exercise (CARE)

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Cognitive Impairment — all drugs for Cognitive Impairment →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

Arizona State University

Who can join

65 and older, any sex, with Mild Cognitive Impairment or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. NeuroMusic: protocol for a randomised-controlled trial of keyboard and singing music training programmes for older adults with mild cognitive impairment.
   Menczel Schrire Z, Mitchell HF, Low LF, Espinosa N, et al · · 2025 · PMID 41360445 · DOI 10.1136/bmjopen-2025-104158
2. Precision exercise in older adults with early Alzheimer's disease: The study protocol of the FIT-AD Sequential, Multiple Assignment, Randomized Trial (SMART).
   Yu F, Todd M, Salisbury D, Maxfield M, et al · · 2025 · PMID 41094623 · DOI 10.1186/s13063-025-09040-0