Recruiting

Observational Study

Sponsor:

University of Iowa

Code:

NCT06338774

Conditions

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

Cognitive training

Exercise

Study Details

Brief summary:

This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:

  • Can cognitive training designed to improve cognitive control improve physical activity adherence?
  • What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?

Participants will

  • Complete a 6-week home-based, computerized cognitive training program
  • Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer
  • Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer
  • Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness

Conditions

Physical Inactivity

Study ID

NCT06338774

Start date

Sep 1, 2024

Status verified date

Dec, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Between the ages of 40 and 65 years old
  • Full-time working status of an average of 35 hrs./week or more
  • Scoring as "Low Active" by the short form of the International Physical Activity Questionnaire (IPAQ)
  • Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire
  • Approval from their Primary Care Physician for approval to participate in the prescribed training program
  • Corrected vision of 20/40
  • Fluent in English to ensure instructions for cognitive assessments and training are understood clearly

Exclusion Criteria:

  • Impairments in hearing inhibiting the ability to discuss study instructions or directions
  • Visual impairments that prevent the perception of color, or loss of sight in the visual field
  • Qualify as "high risk" for exercise-induced adverse events by American College of Sports Medicine criteria will be excluded, which includes known or symptomatic chronic cardiovascular or metabolic disease
  • Not fluent in English
  • Inability to comply with experimental instructions or access a tablet or computer to complete computerized training
  • Previous diagnosis of a neurological or psychiatric condition, including diagnosis with any of the following: major depression, Attention Deficit Disorder or attention-deficit/hyperactivity disorder (ADHD), schizophrenia or bipolar disorder, multiple sclerosis, epilepsy, meningitis, Parkinson's disease, stroke, Transient Ischemic Attack (TIA), or brain aneurysm surgery.
  • Previous diagnosis of a heart condition, cardiovascular disease, or a recent cardiovascular event (such as high blood pressure or cholesterol) that would increase the risk for an adverse event in response to vigorous exercise, Chronic obstructive pulmonary disease (COPD), uncontrolled asthma (this includes anyone who has asthma but is not on medication.
  • Previous diagnosis of a chronic condition such as cystic fibrosis, unregulated thyroid disorder (this includes anyone with thyroid disease that is not on medication), untreated diabetes, renal or liver disease, heart murmur, arrhythmia, or irregular heartbeat.
  • Previous brain surgery or injury associated with concussion or loss of consciousness that required rehabilitation or caregiver assistance to regain function (i.e., dressing/personal hygiene)
  • Previous diagnosis of Alzheimer\'s or related dementias
  • Current or previous cancer treatments within the last 6 months
  • Pregnant or trying to get pregnant

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cognitive Control: Neutral (CC-N)

Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented are neutral (not emotionally valenced). After each session, the difficulty of the next session is updated.

experimental: Cognitive Control: Emotionally Valenced (CC-E)

Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented within the tasks are emotionally valenced.

active comparator: Casual Games

Composed of 6 commercially available computer games. It matches the experimental treatment program in overall program use intensity, time-spent attending, delivered rewards, and overall engagement.

Interventions

Cognitive training

Computerized cognitive training completed on any computer or tablet with internet

Exercise

Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist

Primary outcome measure

  • Physical Activity Adherence [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Michelle W Voss, PhD

319-335-2057michelle-voss@uiowa.edu

Charles Hillman, PhD

617.373.8342c.hillman@northeastern.edu

Locations

Psychological and Brain Sciences Building

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Michelle W Voss, PhD

319-335-2057michelle-voss@uiowa.edu

Ruthina Malone

319-335-2407ruthina-malone@uiowa.edu

Principal Investigator:

Michelle Voss, PhD

Center for Cognitive and Brain Health

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Charles Hillman, PhD

617-373-8342c.hillman@northeastern.edu

Virginia Davis

617-373-3448vi.davis@northeastern.edu

Principal Investigator:

Charles Hillman, PhD

More Information

Sponsor

University of Iowa

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • health behavior change
  • physical activity adherence
  • exercse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-12-11.