NCT05591313

Brief Summary

This study explores the acute exercise effect on neurocognitive function and also its potential moderators in an exercise setting and Apolipoprotein E (APOE) genetic risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.4 years

First QC Date

October 12, 2022

Last Update Submit

February 4, 2023

Conditions

Keywords

aerobic exerciseAPOE genotypeevent-related potentialexecutive functionexercise prescription

Outcome Measures

Primary Outcomes (3)

  • Stroop task: Response time

    A computerized Stroop task was used to assess participants' inhibitory control and basic information processing. The response time of the correct responses was calculated for the first behavioral index.

    Participants were required to complete the Stroop task approximately 30 min following the cessation of each acute exercise treatment or the 30-min reading.

  • Stroop task: Accuracy

    A computerized Stroop task was used to assess participants' inhibitory control and basic information processing. The accuracy was calculated for the second behavioral index.

    Participants were required to complete the Stroop task approximately 30 min following the cessation of each acute exercise treatment or the 30-min reading.

  • Event-related potential: P3 amplitude

    The event-related potential from parietal electrodes (i.e., P3, Pz, and P4) were initially outputted for the mean P3 amplitude; the averaged mean P3 amplitudes from parietal electrodes was then calculated as the neuroelectrical indices.

    Participants were required to complete the Stroop task while EEG activity was continuously recorded approximately 30 min following the cessation of each acute exercise treatment or the 30-min reading.

Study Arms (4)

Low-intensity with longer duration (40-min) exercise (LI-40)

EXPERIMENTAL

The participants were instructed to complete a volume-matched low-intensity with longer duration (40-min) exercise (LI-40) treatment.

Behavioral: LI-40

Moderate-intensity with 30 min exercise (MI-30)

EXPERIMENTAL

The participants were instructed to complete a volume-matched moderate-intensity with 30 min exercise (MI-30) treatment.

Behavioral: MI-30

High-intensity with shorter duration (16-min) exercise (HI-16)

EXPERIMENTAL

The participants were instructed to complete a volume-matched high-intensity with shorter duration (16-min) exercise (HI-16) treatment.

Behavioral: HI-16

Control treatment (CON)

NO INTERVENTION

The participants in the control treatment (CON) were instructed to complete book reading for 30-min.

Interventions

LI-40BEHAVIORAL

Participants were asked to complete a volume-matched light-intensity exercise for 30-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.

Also known as: Light intensity 40-min exercise
Low-intensity with longer duration (40-min) exercise (LI-40)
MI-30BEHAVIORAL

Participants were asked to complete a volume-matched moderate-intensity exercise for 20-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.

Also known as: Moderate intensity 30-min exercise
Moderate-intensity with 30 min exercise (MI-30)
HI-16BEHAVIORAL

Participants were asked to complete a volume-matched high-intensity exercise for 16-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.

Also known as: High intensity 16-min exercise
High-intensity with shorter duration (16-min) exercise (HI-16)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged between 50 and 70 years old
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard
  • Cognitively normal as mini-mental state examination scores (MMSE) \> 26

You may not qualify if:

  • Neurological or psychiatric disorders
  • Cardiovascular disease
  • Risk of cardiovascular fitness assessment based on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Red-green color blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Sciences, National Taiwan Normal University

Taipei, 106308, Taiwan

Location

Related Publications (1)

  • Chang YK, Etnier JL, Li RH, Ren FF, Ai JY, Chu CH. Acute Exercise Effect on Neurocognitive Function Among Cognitively Normal Late-Middle-Aged Adults With/Without Genetic Risk of AD: The Moderating Role of Exercise Volume and APOE Genotype. J Gerontol A Biol Sci Med Sci. 2024 Feb 1;79(2):glad179. doi: 10.1093/gerona/glad179.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yu-Kai Chang, Ph.D.

    Department of Physical Education and Sport Sciences, National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The present study adopted a counterbalanced design. All participants were instructed to complete four counterbalanced treatments: a) longer duration (LI-40), b) moderate-intensity with 30 min (MI-30), c) high-intensity with shorter duration (HI-16), and d) control treatments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 24, 2022

Study Start

May 17, 2016

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Data are available upon request.

Locations