NCT05877196 · Arizona State University
A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
(SMART)
What this study 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.
View original scientific 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.
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.
Primary outcome measures
Peak oxygen consumption
Time frame: measured at 0 and 6 months
VO2peak will be assessed from the symptom-limited peak cycle-ergometer test
White Matter Hyperintensity volume
Time frame: measured at 0 and 6 months
WMH will be assessed from MRI.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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:
Where
- Phoenix, Arizona
Collaborators
Banner Alzheimer's Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations