The ACT Trial: Effects of Combined Aerobic Exercise and Cognitive Training in MCI
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03313895 |
Recruitment Status :
Recruiting
First Posted : October 18, 2017
Last Update Posted : June 9, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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 |
- Cognition [ Time Frame: Change from baseline to 3, 6, 12, and 18 months ]Change in the composite measures of executive function and episodic memory
- AD-signature cortical thickness [ Time Frame: Change from baseline to 6, 12, and 18 months ]measured by the Magnetic Resonance Imaging (MRI)
- Functional connectivity [ Time Frame: Change from baseline to 6, 12, and 18 months ]measured by functional MRI
- Aerobic fitness [ Time Frame: Change from baseline to 3, 6, 12, and 18 months ]measured by the symptom-limited peak cycle-ergometer test
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Fang Yu, PhD | 602-496-0969 | Fang.Yu.2@asu.edu | |
Contact: Hector Cervanes, MS | 602-496-2292 | hcervant@asu.edu |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |