NCT04638413

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

October 29, 2020

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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) Ă— 100.

    Immediately after the 4 week study

  • 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.

    Daily starting at baseline and for 4 continuous weeks

  • 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.

    Daily starting at baseline and for 4 continuous weeks

Secondary Outcomes (7)

  • Change in Corsi Task performance from baseline to 4 weeks

    At baseline; Immediately after the 4-week study

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

    At baseline; Immediately after the 4-week study

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

    At baseline; Immediately after the 4-week study

  • Change in Cancellation Task performance from baseline to 4 weeks

    At baseline; Immediately after the 4-week study

  • Change in Flanker Task performance from baseline to 4 weeks

    At baseline; Immediately after the 4-week study

  • +2 more secondary outcomes

Other Outcomes (1)

  • Executive functioning

    At baseline; Immediately after the 4-week study

Study Arms (2)

Walking regimen (W)

EXPERIMENTAL
Behavioral: Walking (W)

Walking regimen + gamified inhibitory control training (W+PolyRules!)

EXPERIMENTAL
Behavioral: Walking + PolyRules! (W+PolyRules!)

Interventions

Walking (W)BEHAVIORAL

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

Walking regimen (W)

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

Walking regimen + gamified inhibitory control training (W+PolyRules!)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Sarah J Salvy, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 20, 2020

Study Start

May 26, 2022

Primary Completion

January 4, 2023

Study Completion

February 12, 2025

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations