NCT05879341

Brief Summary

The goal of this observational study is to study the effect of gene polymorphism on cognitive improvement in response to exercise in healthy participants. The main questions it aims to answer are: To investigate whether FNDC5/Irisin genotype polymorphism affects cognitive function and inter-individual variability in exercise response. To explore whether the FNDC5/Irisin gene polymorphism can act alone or interact with the BDNF gene to cause inter-individual differences in cognitive function responses to exercise gain. Participants will be asked to perform high-intensity interval training( HIIT) on a cycle ergometer. Each high-intensity training period will be 30 seconds followed by a 4-minute rest period. The participants will also perform cognitive tests (Vistorian stroop test and Fitlight trainer test) before and after the exercise.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

April 6, 2023

Last Update Submit

May 25, 2023

Conditions

Keywords

IrisinCognitionPolymorphismHigh intensity interval training

Outcome Measures

Primary Outcomes (8)

  • Change in Serum BDNF levels

    Serum brain derived neurotrophic factor levels

    The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise BDNF levels

  • Change in Serum BDNF levels

    Serum brain derived neurotrophic factor levels

    The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise BDNF levels

  • Change in Serum Irisin Levels

    Serum Irisin levels

    The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise Irisin levels

  • Change in Serum Irisin Levels

    Serum Irisin levels

    The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise Irisin levels

  • Change in Stroop Reaction time

    Reaction time for Victorian version of Stroop test

    Baseline

  • Change in Stroop Reaction time

    Reaction time for Victorian version of Stroop test

    Immediately after the procedure

  • Change in Fitlight reaction time

    Mean Reaction time to Fitlight Trainer complex patterns

    Baseline

  • Change in Fitlight reaction time

    Mean Reaction time to Fitlight Trainer complex patterns

    Immediately after the procedure

Secondary Outcomes (3)

  • Monitor the Heart rate

    During the procedure

  • Change in Fitlight simple reaction time

    Baseline

  • Change in Fitlight simple reaction time

    Immediately after the procedure

Interventions

The participants will perform HIIT at 85% of their heart rate reserve. There will be 8 cycles of high intensity with four minutes of rest intervals in between.

Also known as: HIIT, High intensity interval Exercise

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Taiwanese National who perform less than 120 minutes of aerobic exercise per week.

You may qualify if:

  • Taiwanese National who perform less than 120 minutes of aerobic exercise per week.
  • The subjects will refrain from drinking alcoholic or caffeinated drinks 24 hours prior to the participation in the study

You may not qualify if:

  • Subjects who are diagnosed with
  • Hypertension
  • Arrhythmia
  • Depression
  • Color blindness
  • Musculoskeletal injury within one year
  • Body Mass index higher than 25
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample will be collected from the participants which will be used to extract serum and DNA. Serum will be used to measure Irisin and BDNF levels. DNA will be used for BDNF and Irisin SNP Geno-typing.

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dean-Chuan Wang, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean-Chuan Wang, PhD

CONTACT

Muhammad Asad Chaudhary, MS

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 30, 2023

Study Start

June 10, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations