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Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD

Primary Purpose

Alzheimer Disease 2 Due to Apoe4 Isoform

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

LI-40

MI-30

HI-16

About this trial

This is an interventional treatment trial for Alzheimer Disease 2 Due to Apoe4 Isoform focused on measuring aerobic exercise, APOE genotype, event-related potential, executive function, exercise prescription

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

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

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

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

Control treatment (CON)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05591313

First Posted

October 12, 2022

Last Updated

February 4, 2023

Sponsor

National Taiwan Normal University

1. Study Identification

Unique Protocol Identification Number

NCT05591313

Brief Title

Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD

Official Title

Acute Exercise Effect on Neurocognitive Function Among Cognitively Normal Late-Middle-Aged Adults With/Without Generic Risk of Alzheimer's Disease: The Moderation Role of Exercise Volume and Apolipoprotein E Genotype

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

May 17, 2016 (Actual)

Primary Completion Date

September 26, 2019 (Actual)

Study Completion Date

September 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Taiwan Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Acute exercise has emerged as a modifier to multiple aspects of cognitive function; however, its effect on populations with different risks of Alzheimer's disease (AD) and the role of exercise variance and APOE genotype within the effect reminds underestimated. The current study aimed to examine the acute exercise effect on neurocognitive function from behavioral and neuroelectric perspectives among cognitively normal late-middle-aged adults. Additionally, we determined whether variations in exercise intensity and duration and the presence of the APOE ɛ4 allele modulated the effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease 2 Due to Apoe4 Isoform

Keywords

aerobic exercise, APOE genotype, event-related potential, executive function, exercise prescription

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

Control treatment (CON)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

LI-40

Other Intervention Name(s)

Light intensity 40-min exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

MI-30

Other Intervention Name(s)

Moderate intensity 30-min exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

HI-16

Other Intervention Name(s)

High intensity 16-min exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Stroop task: Response time

Description

Time Frame

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

Title

Stroop task: Accuracy

Description

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

Time Frame

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

Title

Event-related potential: P3 amplitude

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Kai Chang, Ph.D.

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Taipei

ZIP/Postal Code

106308

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data are available upon request.

Learn more about this trial

Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD

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