- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05591313
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
51
Phase
- 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
-
-
-
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
Ages Eligible for Study
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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 |
Intervention / Treatment |
---|---|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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
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.
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)
May 17, 2016
Primary Completion (ACTUAL)
September 26, 2019
Study Completion (ACTUAL)
September 26, 2019
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 19, 2022
First Posted (ACTUAL)
October 24, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 4, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Alzheimer Disease 2 Due to Apoe4 Isoform
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
-
Yu-Hsiang WuVanderbilt University Medical Center; National Institute on Deafness and Other...RecruitingAlzheimer Disease 2 Due to Apoe4 Isoform | Presbycusis, BilateralUnited States
-
University College, LondonWashington University School of Medicine; University of Washington; Alzheimer... and other collaboratorsNot yet recruitingAlzheimer Disease | Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) | Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) | Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder)
-
Douglas Mental Health University InstituteJohns Hopkins University; McGill UniversityCompletedAlzheimer Disease | Cognitive Decline Due to Alzheimer Disease | Mild Cognitive Impairment Due to Alzheimer DiseaseCanada
-
Central Hospital, Nancy, FranceRecruitingRespiratory Compliance | ARDS Due to Disease Caused by SARS Co-V-2 | Sequels of COVIDFrance
-
Kepler University HospitalCompletedARDS Due to Disease Caused by SARS Co-V-2Austria
-
The First Hospital of Jilin UniversityCompletedARDS Due to Disease Caused by SARS Co-V-2China
-
Prehospital Center, Region ZealandNot yet recruitingDrowning | Drowning, Near | Submersion | Submersion - Accidental | Submersion or Drowning Due to Being Washed Overboard | Submersion or Drowning Due to Being Thrown Overboard | Submersion or Drowning Due to Ship Sinking, Water Skier Injured | Submersion or Drowning Due to Boat Submerging, Swimmer... and other conditionsDenmark
-
University of the Balearic IslandsFundació d'investigació Sanitària de les Illes Balears; Consorcio Centro de...RecruitingMild Cognitive Impairment Due to Alzheimer's Disease | Dementia Due to Alzheimer's Disease (Disorder)Spain
-
Mansoura UniversityActive, not recruitingPartial Edentulism Class 2 Due to Periodontal DiseaseEgypt
Clinical Trials on LI-40
-
Zealand University HospitalCompleted
-
Capital Medical UniversityBeijing Friendship Hospital; China-Japan Friendship HospitalRecruitingAlzheimer DiseaseChina
-
Rambam Health Care CampusMedispecCompleted
-
Rambam Health Care CampusMedispecCompleted
-
Hillel Yaffe Medical CenterUnknown
-
Uppsala UniversityNanjing Sport Institute; Nanjing Maigaoqiao Community Health Service CenterCompleted
-
Odense University HospitalUnknownErectile Dysfunction | Radical Prostatectomy | Extracorporeal Shockwave TherapyDenmark
-
Instituto para la Evaluación de la Calidad y Atención...Boston Medical GroupUnknownErectile DysfunctionColombia
-
Mansoura UniversityAhmed Mohamed ElshalCompletedOveractive Bladder | Urinary Incontinence, Urge | Urgency-frequency Syndrome | Post ProstatectomyEgypt
-
Chang Gung Memorial HospitalNational Science Council, TaiwanCompletedCerebrovascular AccidentTaiwan