Cognitive Training Through Gaming and Walking

NCT ID: NCT04638413

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2025-02-12

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

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.

Conditions

Healthy Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Walking regimen (W)

Group Type: EXPERIMENTAL

Walking (W)

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Walking + PolyRules! (W+PolyRules!)

Intervention Type: BEHAVIORAL

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

Interventions

Walking (W)

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Salvy

Professor, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah J Salvy, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

STUDY00001030

Identifier Type: -

Identifier Source: org_study_id