NCT06479265

Brief Summary

The purpose of this study is to investigate the performance effects of manipulating the properties of a cognitively engaging aerobic task. The overall goal of this proposal is to determine how changes in aspects of the task (selection time, number of sorting options) and inclusion of different dual task walking interferences can be used to challenge the cognitive domain of executive function in a range of healthy adults. The investigators hope to learn how to challenge people cognitively during exercise to promote mental benefits. Participants are invited as a possible participant because are a healthy adult. 40 participants will take part in the study. This research is being funded by the Clinical Exercise Research Center (CERC) in the Division of Biokinesiology and Physical Therapy on the University of Southern California Health Sciences Campus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 13, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive Task Performance

    Score of the Wisconsin Card Sorting Task 64 for each Trial

    90 minutes - 120 minutes

Study Arms (2)

Older Adults

Healthy, adult age 65-75.

Other: Phyical/Cognitve Exercise

Younger Adults

Healthy, young adult age 18-29.

Other: Phyical/Cognitve Exercise

Interventions

Participants will report to the CERC and review informed consent with a study investigator. Eligibility assessments (PAR-Q, WCST64, Medical History) will be done post-consent. Data collected will include age, body composition, gender, aerobic capacity, chronic medication use, and treated pathologies. All measurements will occur during one visit. Participants will lay supine for 5 minutes to measure resting heart rate (HR) using an HR monitor. This resting HR, with age-predicted HR max, will determine HR reserve (HRR). Participants will master the WCST64 and identify walking pace on the Blue Goji treadmill. They will complete a baseline 10 Meter Walk Test, followed by the digital WCST64 under 7 conditions, ending with a post-intervention 10 Meter Walk Test.

Older AdultsYounger Adults

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy 18-29 year old men and women and health 65-75 year old men and women.

You may qualify if:

  • year old men and women; 65-75 year old men and women
  • Competency in English sufficient for assessment and training
  • Able to see and hear sufficiently to participate
  • Answer YES to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or receive medical clearance from a physician

You may not qualify if:

  • History of known neurological disease (e.g., Epilepsy, Multiple sclerosis, Parkinson disease, Alzheimer's disease), cerebral infarct (e.g., Stroke), or traumatic brain injury
  • History of known cardiovascular or metabolic disease or chronic illness which may compromise the patient's ability to safely perform the aerobic exercise (e.g., coronary artery disease, arrhythmia, asthma requiring an inhaler during exercise), or presently uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg).
  • Musculoskeletal injuries interfering with the ability to perform aerobic exercise or medical conditions for which exercise in contraindicated
  • Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems, must not use this equipment. Safe, low-level currents will flow through the body duringthe test, which may cause malfunctioning of the device or endanger lives.
  • Bioelectrical Impedance Analysis (BIA) uses safe low level currents, which are not harmful to the body. However, we do not recommend pregnant women test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Exercise Research Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Malcolm Jones, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Innovation

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 28, 2024

Study Start

January 15, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations