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

Summary

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

• Moderate Intensity Continuous Training (MICT) · BEHAVIORAL

  Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.

• Chair-based Stretch · BEHAVIORAL

  Stretching while seated for 30-50 minutes, 3 times per week for 6 months.

• High-Intensity Interval Training (HIIT) · BEHAVIORAL

  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.

• Combined Aerobic Resistance Exercise (CARE) · BEHAVIORAL

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Arizona State University, Phoenix, Arizona · RECRUITING