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

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ClinicalTrials.gov Identifier: NCT03313895
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : June 9, 2021
Sponsor:
Collaborators:
University of Rochester
Mayo Clinic
University of St Thomas
University of Minnesota
Information provided by (Responsible Party):
Arizona State University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: ACT Behavioral: Cycling Only Behavioral: Cognitive Training Only Behavioral: Stretching and Mental Stimulating Activities Not Applicable

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cycling Only
Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist
 Behavioral: Cycling Only
Cycling on a recumbent stationary cycle
Active Comparator: Cognitive Training Only
Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
 Behavioral: Cognitive Training Only
Engage in cognitive training on a computer
Experimental: ACT
Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
 Behavioral: ACT
ACT stands for combined aerobic exercise and cognitive training.
Sham Comparator: Stretching and Mental Stimulation Activities
Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist
 Behavioral: Stretching and Mental Stimulating Activities
Stretching exercises and mental stimulating activities on a computer


Outcome Measures
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Primary Outcome Measures :
  1. Cognition [ Time Frame: Change from baseline to 3, 6, 12, and 18 months ]
    Change in the composite measures of executive function and episodic memory


Secondary Outcome Measures :
  1. AD-signature cortical thickness [ Time Frame: Change from baseline to 6, 12, and 18 months ]
    measured by the Magnetic Resonance Imaging (MRI)

  2. Functional connectivity [ Time Frame: Change from baseline to 6, 12, and 18 months ]
    measured by functional MRI

  3. Aerobic fitness [ Time Frame: Change from baseline to 3, 6, 12, and 18 months ]
    measured by the symptom-limited peak cycle-ergometer test

  4. Conversion to Alzheimer's diseae [ Time Frame: Change in clinical status from MCI to AD at 6, 12, and 18 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313895


Contacts
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Contact: Fang Yu, PhD 602-496-0969 Fang.Yu.2@asu.edu
Contact: Hector Cervanes, MS 602-496-2292 hcervant@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85004
Contact: Hector Cervanes, MS    602-496-2292    hcervant@asu.edu   
Contact: Ferdinand Delgado, MS       fdelgad5@asu.edu   
Principal Investigator: Fang Yu, PhD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Russell Spafford, MS    612-625-3548    spaff010@umn.edu   
Contact: Dereck Salisbury, PhD    612-625-9939    salis048@umn.edu   
Principal Investigator: Dereck Salisbury, PhD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Nicholas Verhoef, MS    585-276-6834    Nicholas_verhoef@urmc.rochester.edu   
Principal Investigator: Kathi Heffner, PhD         
Sponsors and Collaborators
Arizona State University
University of Rochester
Mayo Clinic
University of St Thomas
University of Minnesota
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03313895    
Other Study ID Numbers: STUDY00001135
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arizona State University:
cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders