Exercise and Neurocognition in Adults Relative to ApoE Genotype

Aging Clinical Trial

Official title:

Effects of an Integrated Intervention Program on Neurocognition in Late-Middle-Aged and Older Adults Relative to ApoE Genotypes: An ERP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101174
• Other study ID #: PACNL_IIP and Neurocog_ERP
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: National Taiwan Normal University
• Contact: Yu-Kai Chang, PhD
• Phone: +886277493220
• Email: yukaichangnew[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Aging
• Exercise Training
• Neurocognitive Function

Intervention

Behavioral:
• 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.
• Control Group
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).

Locations

Country	Name	City	State
Taiwan	Yu-Kai Chang	Taipei
Taiwan	Yu-Kai Normal Chang	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes each at the baseline and at month 6
Primary	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.	60 minutes each at baseline and at month 6
Secondary	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.	5 minutes at baseline
Secondary	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.	5 minutes each at baseline and at month 6
Secondary	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.	30 minutes each at baseline and at month 6
Secondary	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.	15 minutes each at baseline and at month 6
Secondary	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.	15 minutes each at baseline and at month 6
Secondary	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.	5 minutes each at baseline and at month 6
Secondary	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.	5 min each at the Baseline-Assessment and at the Post-Assessment
Secondary	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.	5 minutes each at baseline and at month 6
Secondary	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.	10 minutes each at baseline and at month 6