Cognitive Control to Boost Physical Activity Adherence (BOOST)

March 30, 2024 updated by: Michelle W. Voss, University of Iowa

Targeting Cognitive Control to Improve Physical Activity Adherence in Midlife for Alzheimer's Risk Reduction

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will first be screened to ensure eligibility for participating in moderate to vigorous intensity exercise based on health history and approval from their primary physician or equivalent.

Participants will then complete pre-testing and a three-phased intervention. Pre-intervention sessions include study screening, cognitive testing, physical activity assessment, and sub-maximal cardiorespiratory fitness testing.

Participants will then be randomized into one of three cognitive training programs for a 6-week cognitive training intervention. The cognitive training program includes 15 hours of progressive adaptive training. Participants complete 30 min of training 5 days a week to complete a dose of 15 hours of cognitive training. A minimum of 10 hours of completed cognitive training is needed to progress to the exercise training program.

Upon completion of cognitive training, participants will complete testing to assess changes in cognitive function, and then be enrolled in a two-phase exercise intervention. The 12-week exercise program includes a first 6-week introductory and fully supervised training program that builds towards meeting the minimum suggested exercise per week for long-term health benefits (150 minutes/week of moderate intensity exercise). Following the first 6 weeks, participants will be prescribed a maintenance program to be completed fully at home with their heart rate monitor from the study team, and with safety monitoring from our exercise specialist.

After completing the second 6-week exercise intervention, participants will again complete the cognitive and cardiorespiratory fitness testing they did during pre-intervention sessions.

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Psychological and Brain Sciences Building
        • Principal Investigator:
          • Michelle Voss, PhD
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Center for Cognitive and Brain Health
        • Sub-Investigator:
          • Arthur F Kramer, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Hillman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Cognitive training
Computerized cognitive training completed on any computer or tablet with internet
Behavioral: Exercise
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
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.
Behavioral: Cognitive training
Computerized cognitive training completed on any computer or tablet with internet
Behavioral: Exercise
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
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.
Behavioral: Cognitive training
Computerized cognitive training completed on any computer or tablet with internet
Behavioral: Exercise
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Adherence
Time Frame: 6 weeks
Proportion of moderate to vigorous physical activity achieved while unsupervised.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

National Institute on Aging (NIA)
Northeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202310129
  • R33AG078041 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study protocol and code for analyses will be shared. We are determining the best outlet for this.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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