Clinical trial NCT04638413: Cognitive Training Through Gaming and Walking
Official title: Cognitive Training Through Gaming and Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot study estimates the preliminary efficacy of a walking regime with or without a gamified inhibitory control training app (PolyRules!) on cognitive outcomes among healthy adults.

Detailed description: This pilot study examines the preliminary efficacy 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 is performance changes in attention and inhibitory control \[Cancellation task, Flanker task, and Rule Set task\]; And working memory capacity \[N-Back task, Letter-Numbers task, and Corsi task\]. 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. 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.

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

Primary outcomes:
measure: Change in Flanker Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
measure: Change in Rule Switch Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
measure: Change in Cancellation Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
measure: Change in N-Back Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
measure: Change in Letter-Number Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
measure: Change in Corsi Task performance from baseline to 4 weeks
timeFrame: At baseline; Immediately after the 4-week study
Secondary outcomes:
measure: Adherence to walking regimen
timeFrame: Daily starting at baseline and for 4 continuous weeks
measure: Adherence to gamified cognitive training
timeFrame: Daily starting at baseline and for 4 continuous weeks
measure: Experience with walking regimen and cognitive training
timeFrame: Immediately after the 4-week study
Other outcomes:
measure: Executive functioning
timeFrame: At baseline; Immediately after the 4-week study
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Sarah J Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
References: