Physical InactivityBOOSTNCT06338774
Cognitive Control to Boost Physical Activity Adherence
A study testing Cognitive training and Exercise in people with Physical Inactivity, run by University of Iowa at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Cognitive training and Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Center for Cognitive and Brain Health
Boston, Massachusetts, 02115
Charles Hillman, PhD, 617-373-8342, c.hillman@northeastern.edu
Virginia Davis, 617-373-3448, vi.davis@northeastern.edu
- Recruiting
Psychological and Brain Sciences Building
Iowa City, Iowa, 52242
Michelle W Voss, PhD, 319-335-2057, michelle-voss@uiowa.edu
Ruthina Malone, 319-335-2407, ruthina-malone@uiowa.edu
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Cognitive training, Exercise
- Keywords
- health behavior change, physical activity adherence, exercse
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Computerized cognitive training completed on any computer or tablet with internet
ExerciseBehavioural
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive training; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Adherence
Proportion of moderate to vigorous physical activity achieved while unsupervised.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2024
- Primary completion1 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Six week parallel group intervention, followed by a 12 week exercise program.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michelle W. Voss, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338774
- Sponsor's protocol ID
- 202310129
- Other IDs
- R33AG078041
- Acronym
- BOOST
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol and code for analyses will be shared. We are determining the best outlet for this.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Cognitive Control to Improve Physical Activity Adherence in Midlife for Alzheimer's Risk Reduction
- ClinicalTrials.gov ID
- NCT06338774
- Acronym / sponsor ID
- BOOST / 202310129
- Conditions
- Physical Inactivity
- Keywords
- health behavior change, physical activity adherence, exercse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Northeastern University, National Institute on Aging (NIA)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Six week parallel group intervention, followed by a 12 week exercise program.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Control: Neutral (CC-N) | Experimental | Behavioral: Cognitive training, Behavioral: ExerciseGame-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. |
| Cognitive Control: Emotionally Valenced (CC-E) | Experimental | Behavioral: Cognitive training, Behavioral: ExerciseGame-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. |
| Casual Games | Active comparator | Behavioral: Cognitive training, Behavioral: ExerciseComposed 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingComputerized cognitive training completed on any computer or tablet with internet | Behavioural | Casual Games, Cognitive Control: Emotionally Valenced (CC-E), Cognitive Control: Neutral (CC-N) |
| ExerciseAerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist | Behavioural | Casual Games, Cognitive Control: Emotionally Valenced (CC-E), Cognitive Control: Neutral (CC-N) |
Primary outcome
Physical Activity Adherence
Time frame: 6 weeks
Proportion of moderate to vigorous physical activity achieved while unsupervised.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided. Study protocol and code for analyses will be shared. We are determining the best outlet for this.
Related trials for Physical Inactivity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Exercise in people with Physical Inactivity, run by University of Iowa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle W Voss, PhD (319-335-2057, michelle-voss@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Adherence (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.