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

• ClinicalTrials.gov Identifier: NCT03313895
• Recruitment Status: Recruiting
• First Posted: October 18, 2017
• Last Update Posted: October 29, 2019
• Sponsor: University of Minnesota
• Collaborators: University of Rochester; Mayo Clinic; University of St Thomas
• Information provided by (Responsible Party): University of Minnesota

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Contacts

Contact: Fang Yu, PhD; 612-624-5435; yuxxx244@umn.edu

Contact: Susan Greimel, MS; 612-626-9655; moone104@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Susan Greimel, MS 612-626-9490 moone104@umn.edu

Contact: Fang Yu, PhD 6126245435 yuxxx244@umn.edu

Principal Investigator: Fang Yu, PhD

United States, New York

University of Rochester; Recruiting

Rochester, New York, United States, 14642

Contact: Alanna Jacobs, MS 585-276-5802 Alanna_Jacobs@urmc.rochester.edu

Principal Investigator: Vankee Lin, PhD

Sponsors and Collaborators

University of Minnesota

University of Rochester

Mayo Clinic

University of St Thomas

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li D, Mielke MM, Bell WR, Reilly C, Zhang L, Lin FV, Yu F. Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial). Trials. 2020 Jan 6;21(1):19. doi: 10.1186/s13063-019-3798-1.

Yu F, Lin FV, Salisbury DL, Shah KN, Chow L, Vock D, Nelson NW, Porsteinsson AP, Jack C Jr. Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. Trials. 2018 Dec 22;19(1):700. doi: 10.1186/s13063-018-3054-0.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03313895
• Other Study ID Numbers: STUDY00001135
• First Posted: October 18, 2017
• Last Update Posted: October 29, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders