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

February 4, 2023 updated by: Yu-Kai Chang, National Taiwan Normal University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106308
        • Department of Physical Education and Sport Sciences, National Taiwan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low-intensity with longer duration (40-min) exercise (LI-40)
The participants were instructed to complete a volume-matched low-intensity with longer duration (40-min) exercise (LI-40) treatment.
Behavioral: LI-40
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.
Other Names:
  • Light intensity 40-min exercise
EXPERIMENTAL: Moderate-intensity with 30 min exercise (MI-30)
The participants were instructed to complete a volume-matched moderate-intensity with 30 min exercise (MI-30) treatment.
Behavioral: MI-30
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.
Other Names:
  • Moderate intensity 30-min exercise
EXPERIMENTAL: High-intensity with shorter duration (16-min) exercise (HI-16)
The participants were instructed to complete a volume-matched high-intensity with shorter duration (16-min) exercise (HI-16) treatment.
Behavioral: HI-16
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.
Other Names:
  • High intensity 16-min exercise
NO_INTERVENTION: Control treatment (CON)
The participants in the control treatment (CON) were instructed to complete book reading for 30-min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroop task: Response time
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.
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PACNL_EV_ERP_APOE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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