Alzheimer Disease 2 Due to Apoe4 IsoformNCT05591313
Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD
A study testing LI-40, MI-30 and HI-16 in people with Alzheimer Disease 2 Due to Apoe4 Isoform, run by National Taiwan Normal University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease 2 Due to Apoe4 Isoform
- What is being tested?
- LI-40, MI-30 and HI-16
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2016to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological or psychiatric disorders
- Cardiovascular disease
- Risk of cardiovascular fitness assessment based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Red-green color blindness.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Education and Sport Sciences, National Taiwan Normal University
Taipei, 106308
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer Disease 2 Due to Apoe4 Isoform
- Being tested
- LI-40, MI-30, HI-16
- Keywords
- aerobic exercise, APOE genotype, event-related potential, executive function, exercise prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LI-40Behavioural
Also called Light intensity 40-min exercise
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.
MI-30Behavioural
Also called Moderate intensity 30-min exercise
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.
HI-16Behavioural
Also called High intensity 16-min exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: HI-16 |
| Control treatment (CON) | No intervention | The participants in the control treatment (CON) were instructed to complete book reading for 30-min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 May 2016
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease 2 Due to Apoe4 IsoformStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Kai Chang, National Taiwan Normal University
- Investigators
- Yu-Kai Chang, Ph.D., Study director, Department of Physical Education and Sport Sciences, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591313
- Sponsor's protocol ID
- PACNL_EV_ERP_APOE
- Status last verified
- Feb 2023
- First submitted
- 12 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon request.
Publications
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.
PubMed 37526237
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05591313
- Acronym / sponsor ID
- PACNL_EV_ERP_APOE
- Conditions
- Alzheimer Disease 2 Due to Apoe4 Isoform
- Keywords
- aerobic exercise, APOE genotype, event-related potential, executive function, exercise prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 17 May 2016 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-intensity with longer duration (40-min) exercise (LI-40) | Experimental | Behavioral: LI-40The participants were instructed to complete a volume-matched low-intensity with longer duration (40-min) exercise (LI-40) treatment. |
| Moderate-intensity with 30 min exercise (MI-30) | Experimental | Behavioral: MI-30The participants were instructed to complete a volume-matched moderate-intensity with 30 min exercise (MI-30) treatment. |
| High-intensity with shorter duration (16-min) exercise (HI-16) | Experimental | Behavioral: HI-16The participants were instructed to complete a volume-matched high-intensity with shorter duration (16-min) exercise (HI-16) treatment. |
| Control treatment (CON) | No intervention | –The participants in the control treatment (CON) were instructed to complete book reading for 30-min. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Neurological or psychiatric disorders
- Cardiovascular disease
- Risk of cardiovascular fitness assessment based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Red-green color blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LI-40Also: Light intensity 40-min exerciseParticipants 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. | Behavioural | Low-intensity with longer duration (40-min) exercise (LI-40) |
| MI-30Also: Moderate intensity 30-min exerciseParticipants 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. | Behavioural | Moderate-intensity with 30 min exercise (MI-30) |
| HI-16Also: High intensity 16-min exerciseParticipants 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. | Behavioural | High-intensity with shorter duration (16-min) exercise (HI-16) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37526237Chang 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.
- Individual participant dataSharing planned: No. Data are available upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Kai Chang, Ph.D. study director
Department of Physical Education and Sport Sciences, National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LI-40, MI-30 and HI-16 in people with Alzheimer Disease 2 Due to Apoe4 Isoform, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.