The ACT Trial: Effects of Combined Aerobic Exercise and Cognitive Training in MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313895
• Other study ID #: STUDY00001135
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2023
• Source: Arizona State University
• Contact: Fang Yu, PhD
• Phone: 602-496-0969
• Email: Fang.Yu.2[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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, and 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), and Abnormal MRI findings.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• ACT
ACT stands for combined aerobic exercise and cognitive training.
• Cycling Only
Cycling on a recumbent stationary cycle
• Cognitive Training Only
Engage in cognitive training on a computer
• Stretching and Mental Stimulating Activities
Stretching exercises and mental stimulating activities on a computer

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	Arizona State University	Phoenix	Arizona
United States	University of Rochester	Rochester	New York

Sponsors (5)

Lead Sponsor	Collaborator
Arizona State University	Mayo Clinic, University of Minnesota, University of Rochester, University of St Thomas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	Change in the composite measures of executive function and episodic memory	Change from baseline to 3, 6, 12, and 18 months
Secondary	AD-signature cortical thickness	measured by the Magnetic Resonance Imaging (MRI)	Change from baseline to 6, 12, and 18 months
Secondary	Functional connectivity	measured by functional MRI	Change from baseline to 6, 12, and 18 months
Secondary	Aerobic fitness	measured by the symptom-limited peak cycle-ergometer test	Change from baseline to 3, 6, 12, and 18 months
Secondary	Conversion to Alzheimer's diseae	Change in memory, global cognition, and instrumental activities of daily living will be assessed to make a clinical decision if a participant has progressed from MCI to AD	Change in clinical status from MCI to AD at 6, 12, and 18 months