A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
Recruiting · NCT05877196 · Interventional (participants receive a specific treatment) · Lead sponsor: Arizona State University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Arizona State University - Phoenix, Arizona, United States