Exercise TrainingNCT05101174
Exercise and Neurocognition in Adults Relative to ApoE Genotype
A study testing Integrated Intervention Group (IIG) in people with Exercise Training and Neurocognitive Function, run by National Taiwan Normal University at 2 sites in Taiwan.
Trial summary
The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Neurocognitive Function, Aging
- What is being tested?
- Integrated Intervention Group (IIG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 Apr 2022to Sep 2025
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal or corrected-to-normal vision
- Able to speak and read Chinese
- Scores of Mini-Mental Status Examination >= 25
- Physical Activity Readiness Questionnaire score < 0
- Able to conduct the exercise with moderate intensity
- Provide informed consent
Who cannot join
- Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
- Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
- Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
- Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease or other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
- History of alcohol or drug abuse
- History of chemotherapy
Show all 9Show fewer
- Traveling consecutively for three weeks or more during the study
- Unwillingness to be randomized to one of the two groups
- Currently participating in another study trial
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Yu-Kai Chang
Taipei, 106
Yu-Kai Chang, PhD, +886277493220, yukaichangnew@gmail.com
- Recruiting
Yu-Kai Normal Chang
Taipei, 162
Yu-Kai Chang, +886277493220, yukaichangnew@gmail.com
About this study
Official title: Effects of an Integrated Intervention Program on Neurocognition in Late-Middle-Aged and Older Adults Relative to ApoE Genotypes: An ERP Study
The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.
Read the detailed description
The current randomized clinical trial is designed to examine (1) whether a 6-month integrated intervention program (IIP) consisting of multiple exercise modalities, meditation, and social interaction could benefit neurocognitive function (e.g., inhibition) in middle-aged and older adults; (2) whether components of ERP will be influenced by the integrated intervention program; and (3) whether apolipoprotein E (ApoE) genotypes (ApoE e3/e4, ApoE e4/e4, ApoE e2/e2, ApoE e2/e3, ApoE e2/e4, and ApoE e3/e3), physical fitness, and brain-derived neurotrophic factor (BDNF) will influence the effects of an integrated intervention program on neurocognitive function and components of ERPs.
The study will randomly assign 100 eligible participants to either the IIP group or the control group in a 1:1 ratio. The IIP group will engage in 150 min of exercise per week, which consists of one 90-min on-site session and multiple online sessions, for 6 months. The control group will be invited to attend one 60-minutes online educational course per week for 6 months.
The neurocognitive function, the components of ERP, ApoE genotype, physical fitness, and BDNF will be assessed at the baseline (Baseline-Assessment) and the end of the 6-month intervention (Post-Assessment).
- Conditions
- Exercise Training, Neurocognitive Function, Aging
- Being tested
- Integrated Intervention Group (IIG), Control Group
- Keywords
- physical fitness, meditation, social interaction, Apolipoprotein E, aging, event-related potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Intervention Group (IIG)Behavioural
The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised session and multiple online sessions for 6 months. Each session consists of (1) warm-up, (2) resistance exercise and flexibility exercise, (3) resistance exercise and coordinative exercise from the "Eastern exercise" perspective, (4) social interaction exercise, and (5) cool-down and meditation.
Control GroupBehavioural
The Control Group is informed to maintain their lifestyles and invited to attend one 60-min online educational course per week. The participants are required to provide their physical activity behavior once every month for 6 months (6 times).
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intervention Group (IIG) | Experimental | The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised program and multiple online sessions, for 6 months.
Intervention: aerobic exercise, resistance exercise, coordinative exercise, flexibility, social interaction, and meditation. Receives: Behavioral: Integrated Intervention Group (IIG) |
| Control Group | Other | The control group is invited to attend one 60-min online educational course per week for 6 months.
Intervention: 60-min online educational program. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition: Changes in Stroop test performance
The computerized Stroop test is administrated to assess participants' inhibitory function, and the changes in Stroop test performance from baseline to end of the intervention (i.e., month 6) will be examined.
Measured: 30 minutes each at the baseline and at month 6
Changes in neuroelectrical activities
The neuroelectrical activities during the computerized cognitive tasks is recorded and analyzed using the Neuroscan system. Changes in the neuroelectrical activities from baseline to end of the intervention (i.e., month 6) will be examined.
Measured: 60 minutes each at baseline and at month 6
Secondary outcomes (9)
ApoE genotype
A 6 mL serum sample is drawn from the antecubital veins. Based on the genetic biomarkers (rs429358 and rs7412), participants' ApoE genotype is determined at the baseline.
Measured: 5 minutes at baseline
Blood neurotrophic marker: Changes in brain-derived neurotrophic factor (BDNF) levels
A 6 mL serum sample is drawn from the antecubital veins to assess BDNF levels, and changes in BDNF levels from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 5 minutes each at baseline and at month 6
Physical fitness measurements: Changes in aerobic fitness
Participants' aerobic fitness is assessed using the submaximal cycle ergometer test, and changes in aerobic fitness from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 30 minutes each at baseline and at month 6
Physical fitness measurements: Changes in muscular fitness
Muscular fitness is assessed using either the push-up test/30 seconds or the chair stand test/30 seconds, and changes in muscular fitness from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 15 minutes each at baseline and at month 6
Physical fitness measurements: Changes in flexibility
Flexibility is assessed using the sit-and-reach test, and changes in flexibility from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 15 minutes each at baseline and at month 6
Psychosocial measures: Changes in mindfulness
Mindfulness level is assessed using the 15-items (1-6 Likert scale) Chinese version of the Mindful Attention Awareness Scale (MAAS) questionnaire. Higher mean scores of the 15 items indicate higher levels of dispositional mindfulness. Changes in mindfulness scores from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 5 minutes each at baseline and at month 6
Psychosocial measures: Changes in depression
Geriatric Depression Scale (GDS-15) is utilized to assess older adults' depression levels using 15 'Yes/No' items. Scores between 5 and 9 indicate mild symptoms, and a score of 10 and above indicates moderate symptoms. Changes in depression from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in sleeping quality
The Chinese version of the Pittsburgh Sleep Quality Index will be used to assess individual's general sleep quality over a 1-month time interval. Participants complete 9 questions, and lower scores reflect better sleep quality. Changes in sleep quality from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 5 minutes each at baseline and at month 6
Psychosocial measures: Changes in health-related quality of life
Health-related quality of life via the 24-items (1-5 Likert scale) WHOQOL-OLD-Taiwan is used to measure the quality of life in older persons. The higher scores indicate better quality of life. Changes in health-related quality of life from baseline to end of intervention (i.e., month 6) will be examined.
Measured: 10 minutes each at baseline and at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start11 Apr 2022
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
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, PhD, Principal investigator, Department of Physical Education and Sport Sciences, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101174
- Sponsor's protocol ID
- PACNL_IIP and Neurocog_ERP
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Integrated Intervention Program on Neurocognition in Late-Middle-Aged and Older Adults Relative to ApoE Genotypes: An ERP Study
- ClinicalTrials.gov ID
- NCT05101174
- Acronym / sponsor ID
- PACNL_IIP and Neurocog_ERP
- Conditions
- Exercise Training, Neurocognitive Function, Aging
- Keywords
- physical fitness, meditation, social interaction, Apolipoprotein E, aging, event-related potential
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Nov 2021 (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.
The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.
Detailed description
The current randomized clinical trial is designed to examine (1) whether a 6-month integrated intervention program (IIP) consisting of multiple exercise modalities, meditation, and social interaction could benefit neurocognitive function (e.g., inhibition) in middle-aged and older adults; (2) whether components of ERP will be influenced by the integrated intervention program; and (3) whether apolipoprotein E (ApoE) genotypes (ApoE e3/e4, ApoE e4/e4, ApoE e2/e2, ApoE e2/e3, ApoE e2/e4, and ApoE e3/e3), physical fitness, and brain-derived neurotrophic factor (BDNF) will influence the effects of an integrated intervention program on neurocognitive function and components of ERPs.
The study will randomly assign 100 eligible participants to either the IIP group or the control group in a 1:1 ratio. The IIP group will engage in 150 min of exercise per week, which consists of one 90-min on-site session and multiple online sessions, for 6 months. The control group will be invited to attend one 60-minutes online educational course per week for 6 months.
The neurocognitive function, the components of ERP, ApoE genotype, physical fitness, and BDNF will be assessed at the baseline (Baseline-Assessment) and the end of the 6-month intervention (Post-Assessment).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention Group (IIG) | Experimental | Behavioral: Integrated Intervention Group (IIG)The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised program and multiple online sessions, for 6 months. Intervention: aerobic exercise, resistance exercise, coordinative exercise, flexibility, social interaction, and meditation. |
| Control Group | Other | Behavioral: Control GroupThe control group is invited to attend one 60-min online educational course per week for 6 months. Intervention: 60-min online educational program. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Normal or corrected-to-normal vision
- Able to speak and read Chinese
- Scores of Mini-Mental Status Examination >= 25
- Physical Activity Readiness Questionnaire score < 0
- Able to conduct the exercise with moderate intensity
Key exclusion criteria (9 listed)
- Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
- Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
- Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
- Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease or other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
- History of alcohol or drug abuse
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 |
|---|---|---|
| Integrated Intervention Group (IIG)The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised session and multiple online sessions for 6 months. Each session consists of (1) warm-up, (2) resistance exercise and flexibility exercise, (3) resistance exercise and coordinative exercise from the "Eastern exercise" perspective, (4) social interaction exercise, and (5) cool-down and meditation. | Behavioural | Integrated Intervention Group (IIG) |
| Control GroupThe Control Group is informed to maintain their lifestyles and invited to attend one 60-min online educational course per week. The participants are required to provide their physical activity behavior once every month for 6 months (6 times). | Behavioural | Control Group |
Primary outcome
Inhibition: Changes in Stroop test performance
Time frame: 30 minutes each at the baseline and at month 6
The computerized Stroop test is administrated to assess participants' inhibitory function, and the changes in Stroop test performance from baseline to end of the intervention (i.e., month 6) will be examined.
Changes in neuroelectrical activities
Time frame: 60 minutes each at baseline and at month 6
The neuroelectrical activities during the computerized cognitive tasks is recorded and analyzed using the Neuroscan system. Changes in the neuroelectrical activities from baseline to end of the intervention (i.e., month 6) will be examined.
9 secondary outcomes
ApoE genotype
Time frame: 5 minutes at baseline
Blood neurotrophic marker: Changes in brain-derived neurotrophic factor (BDNF) levels
Time frame: 5 minutes each at baseline and at month 6
Physical fitness measurements: Changes in aerobic fitness
Time frame: 30 minutes each at baseline and at month 6
Physical fitness measurements: Changes in muscular fitness
Time frame: 15 minutes each at baseline and at month 6
Physical fitness measurements: Changes in flexibility
Time frame: 15 minutes each at baseline and at month 6
Psychosocial measures: Changes in mindfulness
Time frame: 5 minutes each at baseline and at month 6
Psychosocial measures: Changes in depression
Time frame: 5 min each at the Baseline-Assessment and at the Post-Assessment
Psychosocial measures: Changes in sleeping quality
Time frame: 5 minutes each at baseline and at month 6
Psychosocial measures: Changes in health-related quality of life
Time frame: 10 minutes each at baseline and at month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
Department of Physical Education and Sport Sciences, National Taiwan Normal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Intervention Group (IIG) in people with Exercise Training and Neurocognitive Function, run by National Taiwan Normal University at 2 sites 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Kai Chang, PhD (+886277493220, yukaichangnew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition: Changes in Stroop test performance (time frame: 30 minutes each at the baseline and at month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023.