Exercise and Neurocognition in Adults Relative to ApoE Genotype

NCT05101174 | Unknown

• 1 other identifier: PACNL_IIP and Neurocog_ERP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Exercise Training; Neurocognitive Function; Aging

Keywords

physical fitness; meditation; social interaction; Apolipoprotein E; aging; event-related potential

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• ApoE genotype

  5 minutes at baseline

• Blood neurotrophic marker: Changes in brain-derived neurotrophic factor (BDNF) levels

  5 minutes each at baseline and at month 6

• Physical fitness measurements: Changes in aerobic fitness

  30 minutes each at baseline and at month 6

• Physical fitness measurements: Changes in muscular fitness

  15 minutes each at baseline and at month 6

• Physical fitness measurements: Changes in flexibility

  15 minutes each at baseline and at month 6

Study Arms (2)

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.

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.

Behavioral: Control Group

Interventions

Integrated Intervention Group (IIG) BEHAVIORAL

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.

Integrated Intervention Group (IIG)

Control Group BEHAVIORAL

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).

Control Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Normal University: lead

Study Sites (2)

Yu-Kai Chang

Taipei, 106, Taiwan

NOT YET RECRUITING

Yu-Kai Normal Chang

Taipei, 162, Taiwan

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yu-Kai Chang, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Kai Chang, PhD

CONTACT

+886277493220; yukaichangnew@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: November 1, 2021
• Study Start: April 11, 2022
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)