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Mild Cognitive ImpairmentNCT03313895

The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial

A study testing Aerobic & Cognitive Training (ACT), Cycling Only and Cognitive Training Only in people with Mild Cognitive Impairment, run by Arizona State University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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])… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Aerobic & Cognitive Training (ACT), Cycling Only and Cognitive Training Only
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
4 sitesUnited States
Study dates
5 Jul 2018to 17 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • A clinical diagnosis of MCI
  • Community-dwelling
  • Age 65 years and older
  • English-speaking
  • Adequate visual acuity
  • Verified exercise safety by medical provider
Show all 9Show fewer
  • Stable on drugs affecting cognitive and psychological status
  • Verified MRI safety
  • Capacity to consent

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Arizona State University

    Phoenix, Arizona, 85004

  • University of Rochester

    Rochester, New York, 14642

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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

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).

Read the 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).

Being tested
Aerobic & Cognitive Training (ACT), Cycling Only, Cognitive Training Only, Stretching and Mental Stimulating Activities
Keywords
Alzheimer's disease, exercise, cognitive training, imaging
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic & Cognitive Training (ACT)Behavioural

    ACT stands for combined aerobic exercise and cognitive training.

  • Cycling OnlyBehavioural

    Cycling on a recumbent stationary cycle

  • Cognitive Training OnlyBehavioural

    Engage in cognitive training on a computer

  • Stretching and Mental Stimulating ActivitiesBehavioural

    Stretching exercises and mental stimulating activities on a computer

Study groups in NCT03313895
Study groupRoleWhat they receive
Cycling OnlyActive comparatorModerate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist
Receives: Behavioral: Cycling Only
Cognitive Training OnlyActive comparatorComputerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Receives: Behavioral: Cognitive Training Only
ACTExperimentalModerate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Receives: Behavioral: Aerobic & Cognitive Training (ACT)
Stretching and Mental Stimulation ActivitiesSham comparatorStretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist
Receives: Behavioral: Stretching and Mental Stimulating Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Executive function

    EXAMINER

    Measured: Change from baseline to 3, 6, 12, and 18 months

  2. Episodic memory

    RAVLT and BVMTR

    Measured: Change from baseline to 3, 6, 12, and 18 months

  3. AD-signature cortical thickness

    Magnetic Resonance Imaging (MRI)

    Measured: Change from baseline to 6, 12, and 18 months

  4. Functional connectivity in DMN

    Functional MRI for Default Mode Network

    Measured: Change from baseline to 6, 12, and 18 months

  5. Aerobic fitness

    VO2peak from symptom-limited peak cycle-ergometer test, and 10-m Incremental Shuttle Walk Test

    Measured: Change from baseline to 3, 6, 12, and 18 months

  6. Conversion to Alzheimer's disease

    Clinical adjudication of Alzheimer's disease dementia

    Measured: Change from baseline to 6, 12, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start5 Jul 2018
  3. Primary completion17 Jul 2024
  4. Study completion17 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03313895
Sponsor's protocol ID
STUDY00001135
Status last verified
Aug 2024
First submitted
6 Oct 2017
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu F, Salisbury DL, Todd M, Chow LS, Porsteinsson AP, Maxfield M, Joseph RP, LoVecchio F, Heffner KL, Lin FV. Efficacy of sequential aerobic exercise and cognitive training in older adults with amnestic mild cognitive impairment. Aging Health Res. 2026 Jun;6(2):100283. doi: 10.1016/j.ahr.2026.100283. Epub 2026 May 24.

    PubMed 42524288

  • Derboghossian G, Pituch K, Anthony M, Salisbury D, Lin FV, Yu F. Relationships among cardiorespiratory fitness, brain age, and neurodegeneration in older adults with amnestic mild cognitive impairment. J Alzheimers Dis. 2025 Jun;105(3):945-954. doi: 10.1177/13872877251333613. Epub 2025 Apr 22.

    PubMed 40262108

  • Salisbury DL, Lin FV, Yu F. Testing the iMplementation Framework fOr behavioral and LIfestyLe interventions in AlZheimer's DiseasE (MOBILIZE) via the ACT randomized controlled trial. Sci Rep. 2025 Feb 13;15(1):5341. doi: 10.1038/s41598-025-88890-9.

    PubMed 39948366

  • 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.

    PubMed 31907024

  • 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.

    PubMed 30577848

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic & Cognitive Training (ACT), Cycling Only and Cognitive Training Only in people with Mild Cognitive Impairment, run by Arizona State University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Executive function (time frame: Change from baseline to 3, 6, 12, and 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313895, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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