Cognitive Control to Boost Physical Activity Adherence

NCT06338774 | Recruiting DMC

• 2 other identifiers: 202310129R33AG078041
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 2

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

Keywords

health behavior change; physical activity adherence; exercse

Outcome Measures

Primary Outcomes (1)

• Physical Activity Adherence

  Proportion of moderate to vigorous physical activity achieved while unsupervised.

  6 weeks

Study Arms (3)

Cognitive Control: Neutral (CC-N)

EXPERIMENTAL

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.

Behavioral: Cognitive training; Behavioral: Exercise

Cognitive Control: Emotionally Valenced (CC-E)

EXPERIMENTAL

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.

Behavioral: Cognitive training; Behavioral: Exercise

Casual Games

ACTIVE COMPARATOR

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.

Behavioral: Cognitive training; Behavioral: Exercise

Interventions

Cognitive training BEHAVIORAL

Computerized cognitive training completed on any computer or tablet with internet

Casual Games; Cognitive Control: Emotionally Valenced (CC-E); Cognitive Control: Neutral (CC-N)

Exercise BEHAVIORAL

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

Casual Games; Cognitive Control: Emotionally Valenced (CC-E); Cognitive Control: Neutral (CC-N)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Iowa: lead
• Northeastern University: collaborator

Study Sites (2)

Psychological and Brain Sciences Building

Iowa City, Iowa, 52242, United States

RECRUITING

Center for Cognitive and Brain Health

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Michelle W Voss, PhD

CONTACT

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

Charles Hillman, PhD

CONTACT

617.373.8342; c.hillman@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Six week parallel group intervention, followed by a 12 week exercise program.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (2)