Cognitive Training Through Gaming and Walking

November 4, 2025 updated by: Sarah Salvy, Cedars-Sinai Medical Center
This pilot study evaluated the feasibility of combining daily walking and gamified inhibitory control training. Feasibility was defined by recruitment, retention, and adherence to arm requirements, with secondary, exploratory analyses examining cognitive function outcomes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot study evaluated the feasibility of combining a walking regimen with gamified inhibitory control training (PolyRules!), compared to walking alone, on cognitive outcomes among healthy adults (ages 18 and over). Participants (n=30) will first be asked to wear a Fitbit for one week to capture baseline activity. Participants will then be randomized to (1) walking alone regimen or (2) walking + gamified inhibitory control training for three weeks. Cognitive assessments will be conducted at enrollment and at the end of the 4-week study protocol. The primary outcome of the pilot trial is feasibility as defined by recruitment, retention, and adherence to arm requirements. Engagement and adherence will be operationalized as the frequency and duration of cognitive training passively recorded on the PolyRules! app and frequency and duration of walking as monitored by Fitbit data. Secondary outcomes examined cognitive function outcomes performance: changes in attention and inhibitory control [Cancellation task, Flanker task, and Rule Set task]; And working memory capacity [N-Back task, Letter-Numbers task, and Corsi task]. Qualitative indicators will also be collected via semi-structured interviews to capture participants' satisfaction, perceived benefits of- and/or barriers to engaging with the cognitive training and/or walking regimens.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to read, write, and speak English with acceptable visual and auditory acuity, as the app is only available in English
  • Able and willing to walk independently with or without walking aids
  • Able and willing to engage in 30 minutes of walking daily
  • Able and willing to wear a fitness tracking device (e.g. Fitbit)
  • Not currently engaging in a daily walking regimen of 30 minutes or more a day

Exclusion Criteria:

  • Visual impairments that would preclude participants from using the app
  • Undergoing active cancer treatment
  • Diagnosis of peripheral neuropathy, severe musculoskeletal or neurodegenerative disease (e.g. dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, etc.)
  • Taking medications that may affect cognitive function
  • Pacemaker, implantable cardiac defibrillator, neuro-stimulation devices, cochlear implants, implantable hearing aids, or other electronic medical equipment

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Walking regimen (W)
Behavioral: Walking (W)
Participants engage in 30 min of walking daily, for three weeks.
Experimental: Walking regimen + gamified inhibitory control training (W+PolyRules!)
Behavioral: Walking + PolyRules! (W+PolyRules!)
Participants alternate between 30 min of walking on half of the days and 30 min of gamified inhibitory control on the other days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment and Retention
Time Frame: Immediately after the 4 week study
Percentage of randomized participants who complete the final study visit/assessment at the end of the intervention period. Completion is defined as providing primary outcome data (objective adherence logs), calculated as (number completing final assessment / number randomized) × 100.
Immediately after the 4 week study
Rate of walking regimen completion
Time Frame: Daily starting at baseline and for 4 continuous weeks
Activity will be continuously recorded by the Fitbit to monitor whether participants engage in daily physical activity. There are a total of 9 and 18 walking sessions that may be completed for participants assigned to the control group and intervention group, respectively. Competing one of the sessions entails completing 30 minutes of walking with a wearable. A ratio of completion will be calculated using the number of walking sessions completed over the total amount of sessions possible.
Daily starting at baseline and for 4 continuous weeks
Rate of gamified cognitive training completion
Time Frame: Daily starting at baseline and for 4 continuous weeks
Participants' interactions with the app (PolyRules!) will be passively recorded by the software to monitor training session completion. There are a total of 8 or more sessions that may be completed for participants assigned to the condition. Competing one of the sessions entails completing 30 minutes of cognitive training session using the application. A ratio of completion will be calculated using the number of sessions completed over the total amount of sessions possible.
Daily starting at baseline and for 4 continuous weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Flanker Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
The Flanker Task tests selective attention and inhibitory control. Participants are presented with a row of arrows and are asked whether the centrally presented arrow is pointing either to the left or to the right. In the congruent trials, the non-target arrows point in the same direction as the target arrow and in the incongruent trials they point in the opposite direction. The stimuli are presented in a pseudo-random order in which neither the trial type nor the trial direction can repeat more than three times in a row. Each condition is presented 12 times resulting in 48 total trials. The row of arrows is presented for 500ms with a 500ms break. The location of the row is randomly jittered so that it appears in one of 9 possible locations to prevent participants from fixating their gaze on the location of the central arrow. The user has 15 seconds to choose a response from the moment a trial is presented. Participants should respond as quickly and accurately as possible.
At baseline; Immediately after the 4-week study
Change in Rule Switch Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
The Rule Switch Task is a tablet-based measure of inhibitory control modeled after standard rule switching tasks such as the NIH Examiner (Kramer et al, 2014). In this task, participants must match the stimulus at the top of the screen (either a red or blue circle or square) by selecting one of the buttons (i.e., a red square or blue circle). Participants are instructed to classify the shape by one of two rules, either shape or color. There are 24 color trials and 24 shape trials, half of one shape and half of the other, for a total of 48 trials. There are three variables: shape, color and trial type. The three variables are pseudo-randomly intermixed so that any subset of 5 consecutive trials cannot have one of those traits in common across all 5 trials (no more than 4 trials in a row can share any of the three variable traits in common). There is also a switch rule in that there need to be a minimum of two trials of the same type before switching to a different trial type.
At baseline; Immediately after the 4-week study
Change in Cancellation Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
The Cancellation Task is a timed, tablet-based test of selective attention and inhibitory control, akin to D2 (Brickenkamp & Zilmer, 1998). There are two versions that can be used interchangeably: Cancellation Letters and Cancellation Pictures. Cancellation - Letters resembles the D2 in that it consists of similar stimuli: characters "d" and "p" with one to four dashes, arranged either individually or in pairs above or below the letters. For Letters, the participant must scan the items from left to right and select all "d"s with two dashes (targets). In Cancellation - Pictures, letters are replaced with pictures of dogs and monkeys, some of which are rotated along the vertical axis or are presented upside down. For Pictures, the participant must select the upright dog (tail on the left) and the upside-down monkey (tail on right) separately in single blocks and together in a mixed block.
At baseline; Immediately after the 4-week study
Change in N-Back Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
In the N-Back task, working memory will be assessed. Participants are presented with a consecutive stream of pictures, and the objective is to tap on the pictures that match those presented N items earlier. Higher levels of N levels increase WM load and make the task more difficult. All participants complete 1-back (Figure 4), 2-back, and 3-back (in that order). Before each level starts, there is a practice session consisting of 10 trials during which performance feedback is provided. The test phase for each N-level consists of 30 trials with 9 targets. Progression to 4-back (and beyond) is allowed if the participant made no more than 2 errors on the previous level. Stimuli are presented for 2500 ms (participant can respond during this period) with an ISI of 500 ms.
At baseline; Immediately after the 4-week study
Change in Letter-Number Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
In the Letter-Number task, working memory will be assessed. Participants are presented with a mixed order of letters and numbers, which they must remember and sort them numerically and alphabetically. For example, the sequence 'H8T3K5' would be sorted into '358' and 'HKT'. The mixed orders of letter and numbers ranges from 2 to 15. After a short tutorial, the participant practices the task and must get three out of the five trials correct to proceed to the test. The Letter Number Task is split into two parts: The first is a method of limits to find the participants threshold, whereas the second provides additional trials around that threshold. Characters that could be confused with other letters or numbers are excluded (0, I, O, U, X). Moreover, a given sequence does not include any of the characters in the previous trial and it does not contain consecutive numbers and letters.
At baseline; Immediately after the 4-week study
Change in Corsi Task performance from baseline to 4 weeks
Time Frame: At baseline; Immediately after the 4-week study
Visuospatial working memory will be measured with a modified Corsi Task, a collection of 4 types of tasks (i.e. classic - blocks, simple, complex, sequencing) that are customizable where an experimenter can select which task mode, stimulus type, and algorithm they want to use. In all versions of the task, the participant is shown instructions and then practices the task. Corsi Blocks Classic: The participant first completes Corsi Blocks Forward (tap in same order), followed by Corsi Blocks Reverse (tap in reverse order). The Corsi Blocks Forward task is split into two parts: the first is a method of limits to find the participants threshold, whereas the second provides additional trials around that threshold. Complex Corsi: Combines Simple Corsi with a secondary sorting task in between each trial. In the sorting task, the participant must drag a dog to a bone or a monkey to a banana. The location of the bone and banana are randomized to prevent mnemonic strategies like chunking.
At baseline; Immediately after the 4-week study
Experience with walking regimen and cognitive training
Time Frame: Immediately after the 4-week study
Assessed by semi-structured interviews and will include: participants' satisfaction with the app and/or walking regime; perceived benefits of cognitive training and/or walking; and barriers to engaging with the app and/or walking regime.
Immediately after the 4-week study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Executive functioning
Time Frame: At baseline; Immediately after the 4-week study
Assessed using the Behavior Rating Inventory of Executive Function for Adults (BRIEF-A).
At baseline; Immediately after the 4-week study

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah J Salvy, PhD, Cedars-Sinai Medical Center

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001030

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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