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Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial.

Abstract

BACKGROUND

Developing non-pharmacological interventions with strong potential to prevent or delay the onset of Alzheimer's disease (AD) in high-risk populations is critical. Aerobic exercise and cognitive training are two promising interventions. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective brain function intensively. Hence, combined aerobic exercise and cognitive training may have a synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested the effects of such a combined intervention, and the findings have been discrepant, largely due to varying doses and formats of the interventions.

METHODS/DESIGN

The purpose of this single-blinded, 2 × 2 factorial phase II randomized controlled trial is to test the efficacy and synergistic effects of a 6-month combined cycling and speed of processing training intervention on cognition and relevant mechanisms (aerobic fitness, cortical thickness, and functional connectivity in the default mode network) in older adults with amnestic mild cognitive impairment. This trial will randomize 128 participants equally to four arms: cycling and speed of processing, cycling only, speed of processing only, or attention control for 6 months, and then follow them for another 12 months. Cognition and aerobic fitness will be assessed at baseline and at 3, 6, 12, and 18 months; cortical thickness and functional connectivity at baseline and at 6, 12, and 18 months; Alzheimer's disease (AD) conversion at 6, 12, and 18 months. The specific aims are to (1) determine the efficacy and synergistic effects of the combined intervention on cognition over 6 months, (2) examine the underlying mechanisms of the combined intervention, and (3) calculate the long-term effect sizes of the combined intervention on cognition and AD conversion. The analysis will use intention-to-treat and linear mixed-effects modeling.

DISCUSSION

This trial will be among the first to test the synergistic effects on cognition and mechanisms (relevant to Alzheimer's-associated neurodegeneration) of a uniquely conceptualized and rigorously designed aerobic exercise and cognitive training intervention in older adults with mild cognitive impairment. It will advance Alzheimer's prevention research by providing precise effect-size estimates of the combined intervention.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03313895 . Registered on 18 October 2017.

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  • Authors+Show Affiliations

    ,

    University of Minnesota School of Nursing, 5-160 WDH 1331, 308 Harvard St SE, Minneapolis, MN, 55455, USA. yuxxx244@umn.edu.

    ,

    University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA. vankee_lin@urmc.rochester.edu.

    ,

    University of Minnesota School of Nursing, 5-160 WDH 1331, 308 Harvard St SE, Minneapolis, MN, 55455, USA.

    ,

    University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA.

    ,

    University of Minnesota School of Medicine, Minneapolis, MN, USA.

    ,

    University of Minnesota Division of Biostatistics, Minneapolis, MN, USA.

    ,

    University of St. Thomas, Minneapolis, MN, USA.

    ,

    University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA.

    Department of Radiology, Mayo Clinic, Rochester, MN, USA.

    Source

    Trials 19:1 2018 Dec 22 pg 700

    MeSH

    Age Factors
    Aged
    Bicycling
    Cerebral Cortex
    Clinical Trials, Phase II as Topic
    Cognition
    Cognitive Aging
    Cognitive Behavioral Therapy
    Cognitive Dysfunction
    Executive Function
    Exercise Therapy
    Female
    Humans
    Magnetic Resonance Imaging
    Male
    Memory
    Mental Health
    Multicenter Studies as Topic
    Neuropsychological Tests
    Physical Fitness
    Randomized Controlled Trials as Topic
    Single-Blind Method
    Time Factors
    Treatment Outcome
    United States

    Pub Type(s)

    Clinical Trial Protocol
    Journal Article

    Language

    eng

    PubMed ID

    30577848

    Citation

    Yu, Fang, et al. "Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in Mild Cognitive Impairment: Study Protocol of the ACT Trial." Trials, vol. 19, no. 1, 2018, p. 700.
    Yu F, Lin FV, Salisbury DL, et al. Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. Trials. 2018;19(1):700.
    Yu, F., Lin, F. V., Salisbury, D. L., Shah, K. N., Chow, L., Vock, D., ... Jack, C. (2018). Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. Trials, 19(1), p. 700. doi:10.1186/s13063-018-3054-0.
    Yu F, et al. 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. PubMed PMID: 30577848.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. AU - Yu,Fang, AU - Lin,Feng Vankee, AU - Salisbury,Dereck L, AU - Shah,Krupa N, AU - Chow,Lisa, AU - Vock,David, AU - Nelson,Nathaniel W, AU - Porsteinsson,Anton P, AU - Jack,Clifford,Jr Y1 - 2018/12/22/ PY - 2018/06/02/received PY - 2018/11/14/accepted PY - 2018/12/23/entrez PY - 2018/12/24/pubmed PY - 2019/4/10/medline KW - Aerobic exercise KW - Aerobic fitness KW - Alzheimer’s disease KW - Cognitive training KW - Executive function KW - Memory KW - Neuroimaging SP - 700 EP - 700 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: Developing non-pharmacological interventions with strong potential to prevent or delay the onset of Alzheimer's disease (AD) in high-risk populations is critical. Aerobic exercise and cognitive training are two promising interventions. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective brain function intensively. Hence, combined aerobic exercise and cognitive training may have a synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested the effects of such a combined intervention, and the findings have been discrepant, largely due to varying doses and formats of the interventions. METHODS/DESIGN: The purpose of this single-blinded, 2 × 2 factorial phase II randomized controlled trial is to test the efficacy and synergistic effects of a 6-month combined cycling and speed of processing training intervention on cognition and relevant mechanisms (aerobic fitness, cortical thickness, and functional connectivity in the default mode network) in older adults with amnestic mild cognitive impairment. This trial will randomize 128 participants equally to four arms: cycling and speed of processing, cycling only, speed of processing only, or attention control for 6 months, and then follow them for another 12 months. Cognition and aerobic fitness will be assessed at baseline and at 3, 6, 12, and 18 months; cortical thickness and functional connectivity at baseline and at 6, 12, and 18 months; Alzheimer's disease (AD) conversion at 6, 12, and 18 months. The specific aims are to (1) determine the efficacy and synergistic effects of the combined intervention on cognition over 6 months, (2) examine the underlying mechanisms of the combined intervention, and (3) calculate the long-term effect sizes of the combined intervention on cognition and AD conversion. The analysis will use intention-to-treat and linear mixed-effects modeling. DISCUSSION: This trial will be among the first to test the synergistic effects on cognition and mechanisms (relevant to Alzheimer's-associated neurodegeneration) of a uniquely conceptualized and rigorously designed aerobic exercise and cognitive training intervention in older adults with mild cognitive impairment. It will advance Alzheimer's prevention research by providing precise effect-size estimates of the combined intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03313895 . Registered on 18 October 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30577848/Efficacy_and_mechanisms_of_combined_aerobic_exercise_and_cognitive_training_in_mild_cognitive_impairment:_study_protocol_of_the_ACT_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3054-0 DB - PRIME DP - Unbound Medicine ER -