Clinical trial NCT03313895: The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial
Official title: Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Alzheimer's disease
exercise
cognitive training
imaging
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: Mayo Clinic
name: University of St Thomas
name: University of Minnesota
First posted: 2017-10-18
Enrollment: 146
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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).

Eligibility 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
* 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

Primary outcomes:
measure: Executive function
timeFrame: Change from baseline to 3, 6, 12, and 18 months
measure: Episodic memory
timeFrame: Change from baseline to 3, 6, 12, and 18 months
measure: AD-signature cortical thickness
timeFrame: Change from baseline to 6, 12, and 18 months
measure: Functional connectivity in DMN
timeFrame: Change from baseline to 6, 12, and 18 months
measure: Aerobic fitness
timeFrame: Change from baseline to 3, 6, 12, and 18 months
measure: Conversion to Alzheimer's disease
timeFrame: Change from baseline to 6, 12, and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Arizona State University
name: Fang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.