A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
Launched by ARIZONA STATE UNIVERSITY · May 25, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of aerobic exercise on older adults aged 65 and up who have mild cognitive impairment (MCI) or early stages of Alzheimer's disease. The main goal is to see how regular aerobic exercise can improve fitness levels, brain health, and overall well-being over six months. The researchers will also explore which types of exercise work best and how exercise may help improve memory in these individuals.
If you or a loved one is interested in participating, you must be 65 or older, have a diagnosis of MCI or mild Alzheimer's, and live in the community (like at home or in assisted living). Participants will engage in supervised exercise sessions for six months and undergo various assessments, including brain scans and discussions about health and wellness. It’s important to note that participants need medical clearance from a healthcare provider and will need a study partner who can support them throughout the process. This trial is currently recruiting, so it's a great opportunity for those looking to make a positive impact on their cognitive health through exercise.
Gender
ALL
Eligibility criteria
- 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:
- • none
About Arizona State University
Arizona State University (ASU) is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, ASU leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at improving patient outcomes and contributing to the scientific community. With a commitment to ethical research practices and collaboration with healthcare professionals, ASU strives to translate research findings into practical applications that benefit society. The university's focus on community engagement and real-world impact underscores its role as a pivotal player in the advancement of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Patients applied
Trial Officials
Fang Yu, PhD
Principal Investigator
Arizona State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported