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Healthy LifestyleNCT04638413

Cognitive Training Through Gaming and Walking

A study testing Walking (W) and Walking + PolyRules! (W+PolyRules!) in people with Healthy Lifestyle, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Lifestyle
What is being tested?
Walking (W) and Walking + PolyRules! (W+PolyRules!)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
26 May 2022to 12 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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

Read the 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.

Being tested
Walking (W), Walking + PolyRules! (W+PolyRules!)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking (W)Behavioural

    Participants engage in 30 min of walking daily, for three weeks.

  • Walking + PolyRules! (W+PolyRules!)Behavioural

    Participants alternate between 30 min of walking on half of the days and 30 min of gamified inhibitory control on the other days.

Study groups in NCT04638413
Study groupRoleWhat they receive
Walking regimen (W)ExperimentalNot described
Receives: Behavioral: Walking (W)
Walking regimen + gamified inhibitory control training (W+PolyRules!)ExperimentalNot described
Receives: Behavioral: Walking + PolyRules! (W+PolyRules!)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment and Retention

    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.

    Measured: Immediately after the 4 week study

  2. Rate of walking regimen completion

    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.

    Measured: Daily starting at baseline and for 4 continuous weeks

  3. Rate of gamified cognitive training completion

    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.

    Measured: Daily starting at baseline and for 4 continuous weeks

Secondary outcomes (7)
  1. Change in Corsi Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  2. Change in Letter-Number Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  3. Change in N-Back Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  4. Change in Cancellation Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  5. Change in Flanker Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  6. Change in Rule Switch Task performance from baseline to 4 weeks

    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.

    Measured: At baseline; Immediately after the 4-week study

  7. Experience with walking regimen and cognitive training

    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.

    Measured: Immediately after the 4-week study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start26 May 2022
  3. Primary completion4 Jan 2023
  4. Study completion12 Feb 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638413
Sponsor's protocol ID
STUDY00001030
Status last verified
Nov 2025
First submitted
29 Oct 2020
Last updated
5 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Walking (W) and Walking + PolyRules! (W+PolyRules!) in people with Healthy Lifestyle, run by Cedars-Sinai Medical Center at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and Retention (time frame: Immediately after the 4 week study). The study lists 3 primary outcomes in all. 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 5 Nov 2025.

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