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

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT
Cycling Only
Cognitive Training Only
Stretching and Mental Stimulating Activities
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona State UniversityRecruiting
  • University of MinnesotaRecruiting
  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Sham Comparator

Arm Label

Cycling Only

Cognitive Training Only

ACT

Stretching and Mental Stimulation Activities

Arm Description

Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist

Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist

Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist

Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist

Outcomes

Primary Outcome Measures

Cognition
Change in the composite measures of executive function and episodic memory

Secondary Outcome Measures

AD-signature cortical thickness
measured by the Magnetic Resonance Imaging (MRI)
Functional connectivity
measured by functional MRI
Aerobic fitness
measured by the symptom-limited peak cycle-ergometer test
Conversion to Alzheimer's diseae
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

Full Information

First Posted
October 6, 2017
Last Updated
January 5, 2023
Sponsor
Arizona State University
Collaborators
University of Rochester, Mayo Clinic, University of St Thomas, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03313895
Brief Title
The ACT Trial: Effects of Combined Aerobic Exercise and Cognitive Training in MCI
Official Title
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
University of Rochester, Mayo Clinic, University of St Thomas, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cycling Only
Arm Type
Active Comparator
Arm Description
Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist
Arm Title
Cognitive Training Only
Arm Type
Active Comparator
Arm Description
Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Arm Title
ACT
Arm Type
Experimental
Arm Description
Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Arm Title
Stretching and Mental Stimulation Activities
Arm Type
Sham Comparator
Arm Description
Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
ACT stands for combined aerobic exercise and cognitive training.
Intervention Type
Behavioral
Intervention Name(s)
Cycling Only
Intervention Description
Cycling on a recumbent stationary cycle
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training Only
Intervention Description
Engage in cognitive training on a computer
Intervention Type
Behavioral
Intervention Name(s)
Stretching and Mental Stimulating Activities
Intervention Description
Stretching exercises and mental stimulating activities on a computer
Primary Outcome Measure Information:
Title
Cognition
Description
Change in the composite measures of executive function and episodic memory
Time Frame
Change from baseline to 3, 6, 12, and 18 months
Secondary Outcome Measure Information:
Title
AD-signature cortical thickness
Description
measured by the Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 6, 12, and 18 months
Title
Functional connectivity
Description
measured by functional MRI
Time Frame
Change from baseline to 6, 12, and 18 months
Title
Aerobic fitness
Description
measured by the symptom-limited peak cycle-ergometer test
Time Frame
Change from baseline to 3, 6, 12, and 18 months
Title
Conversion to Alzheimer's diseae
Description
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
Time Frame
Change in clinical status from MCI to AD at 6, 12, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yu, PhD
Phone
602-496-0969
Email
Fang.Yu.2@asu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hector Cervanes, MS
Phone
602-496-2292
Email
hcervant@asu.edu
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Cervanes, MS
Phone
602-496-2292
Email
hcervant@asu.edu
First Name & Middle Initial & Last Name & Degree
Ferdinand Delgado, MS
Email
fdelgad5@asu.edu
First Name & Middle Initial & Last Name & Degree
Fang Yu, PhD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Spafford, MS
Phone
612-625-3548
Email
spaff010@umn.edu
First Name & Middle Initial & Last Name & Degree
Dereck Salisbury, PhD
Phone
612-625-9939
Email
salis048@umn.edu
First Name & Middle Initial & Last Name & Degree
Dereck Salisbury, PhD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Verhoef, MS
Phone
585-276-6834
Email
Nicholas_verhoef@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Kathi Heffner, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31907024
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.
Results Reference
derived
PubMed Identifier
30577848
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.
Results Reference
derived

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

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