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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2024-07-17

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cycling Only

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

Group Type ACTIVE_COMPARATOR

Cycling Only

Intervention Type BEHAVIORAL

Cycling on a recumbent stationary cycle

Cognitive Training Only

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

Group Type ACTIVE_COMPARATOR

Cognitive Training Only

Intervention Type BEHAVIORAL

Engage in cognitive training on a computer

ACT

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

Group Type EXPERIMENTAL

Aerobic & Cognitive Training (ACT)

Intervention Type BEHAVIORAL

ACT stands for combined aerobic exercise and cognitive training.

Stretching and Mental Stimulation Activities

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

Group Type SHAM_COMPARATOR

Stretching and Mental Stimulating Activities

Intervention Type BEHAVIORAL

Stretching exercises and mental stimulating activities on a computer

Interventions

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Aerobic & Cognitive Training (ACT)

ACT stands for combined aerobic exercise and cognitive training.

Intervention Type BEHAVIORAL

Cycling Only

Cycling on a recumbent stationary cycle

Intervention Type BEHAVIORAL

Cognitive Training Only

Engage in cognitive training on a computer

Intervention Type BEHAVIORAL

Stretching and Mental Stimulating Activities

Stretching exercises and mental stimulating activities on a computer

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No