Aerobic exercise program for older adults with mild cognitive impairment
Precision Medicine in Alzheimer's Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-Fitness Responses (The FIT-AD SMART Trial)
This study is testing if a 6-month aerobic exercise program can help older adults with mild cognitive impairment or early Alzheimer's improve their brain health and fitness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT05877196 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a 6-month aerobic exercise program on older adults aged 65 and above who have mild cognitive impairment or early Alzheimer's disease. Participants will engage in various exercise interventions, including moderate intensity continuous training and high-intensity interval training, while undergoing cognitive assessments and MRI scans to monitor changes in brain health and fitness levels. The study seeks to identify the most effective exercise regimen for improving aerobic fitness and cognitive outcomes, as well as to explore the underlying mechanisms of exercise on memory function. Monthly follow-ups will provide additional support and health discussions for participants throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 65 and older with a clinical diagnosis of mild cognitive impairment or early Alzheimer's disease.
Not a fit: Patients with significant cardiac issues or those currently enrolled in other cognitive improvement interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance aerobic fitness and cognitive function in older adults, potentially slowing the progression of Alzheimer's disease.
How similar studies have performed: Previous studies have shown mixed results regarding the effects of aerobic exercise on cognitive function in dementia, indicating that while some approaches have been beneficial, this specific adaptive exercise methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona
- Arizona State University — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Fang Yu, PhD — Arizona State University
- Study coordinator: Kristi Spieleder, MS
- Email: kspieled@asu.edu
- Phone: 480-884-2765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.