The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial

Arizona State University (ASU)

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Cycling Only; Behavioral: Aerobic & Cognitive Training (ACT); Behavioral: Stretching and Mental Stimulating Activities; Behavioral: Cognitive Training Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03313895

STUDY00001135

Details and patient eligibility

About

This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease [AD] signature cortical thickness, and default mode network [DMN]) in older adults with amnestic MCI (aMCI).

Full description

Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment [MCI]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network [DMN]) in older adults with amnestic MCI (aMCI).

Enrollment: 146 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of MCI
• Community-dwelling
• Age 65 years and older
• English-speaking
• Adequate visual acuity
• Verified exercise safety by medical provider
• Stable on drugs affecting cognitive and psychological status
• Verified MRI safety
• Capacity to consent

Exclusion criteria

• Geriatric Depression Scale < 5
• Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min
• Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI
• Contraindications to exercise, e.g. unstable angina, recent surgery
• New symptoms or diseases that have not been evaluated by a health care provider
• Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes)
• Abnormal MRI findings

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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146 participants in 4 patient groups

Cycling Only

Active Comparator group

Description:

Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist

Treatment:

Behavioral: Cycling Only

Cognitive Training Only

Active Comparator group

Description:

Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist

Treatment:

Behavioral: Cognitive Training Only

ACT

Experimental group

Description:

Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist

Treatment:

Behavioral: Aerobic & Cognitive Training (ACT)

Stretching and Mental Stimulation Activities

Sham Comparator group

Description:

Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist

Treatment:

Behavioral: Stretching and Mental Stimulating Activities