NCT05927675

Brief Summary

This study aimed to examine the effect of physical activity (PA) on health through changes in multi-omics biomarkers during 6 months of exercise intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

June 13, 2023

Last Update Submit

June 22, 2023

Conditions

Healthy

Keywords

MicrobiomeMetabolitePhysical activity

Outcome Measures

Primary Outcomes (16)

  • Change in Systolic blood pressure (SBP) between baseline and 3rd month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

    baseline ~ 3 month

  • Change in Systolic blood pressure (SBP) between 3rd month and 6th month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

    3 ~ 6 month

  • Changes in diastolic blood pressure (DBP) between baseline and 3rd month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

    baseline ~ 3 month

  • Changes in diastolic blood pressure (DBP) between 3rd month and 6th month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

    3 ~ 6 month

  • Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month

    The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

    baseline ~ 3 month

  • Changes in hemoglobin A1c (HbA1c) between 3rd month and 6th month

    The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

    3 ~ 6 month

  • Changes in total cholesterol between baseline and 3rd month

    total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    baseline ~ 3 month

  • Changes in total cholesterol between 3rd month and 6th month

    total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    3 ~ 6 month

  • Changes in high-density lipoprotein cholesterol (HDL-C) between baseline and 3rd month

    high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    baseline ~ 3 month

  • Changes in high-density lipoprotein cholesterol (HDL-C) between 3rd month and 6th month

    high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    3 ~ 6 month

  • Changes in low-density lipoprotein cholesterol (LDL-C) betweenbaseline and 3rd month

    low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    baseline ~ 3 month

  • Changes in low-density lipoprotein cholesterol (LDL-C) between 3rd month and 6th month

    low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

    3 ~ 6 month

  • Changes in Microbiome between baseline and 3rd month

    The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

    baseline ~ 3 month

  • Changes in Microbiome between 3rd month and 6th month

    The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

    3 ~ 6 month

  • Changes in Metabolome between baseline and 3rd month

    Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

    baseline ~ 3 month

  • Changes in Metabolome between 3rd month and 6th month

    Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

    3 ~ 6 month

Study Arms (1)

Exercise intervention

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

The exercise intervention program consisted of two distinct periods. During period 1, subjects participated in a moderate to vigorous intensity exercise program for 40 minutes a day, 4 days a week. The exercise program was conducted in Tabata format targeting 70% of the maximum heart rate. Recovery was then induced for 1 minute and 30 seconds, allowing the heart rate to return to resting levels. The exercise routine primarily consisted of full-body exercises, functional training, and power exercises. During period 2, a low-intensity static exercise program was implemented. Similar to period 1, the subjects exercised for 40 minutes a day, 4 days a week. The exercise program included static exercises. The maximum heart rate was maintained below 50%. The detailed exercise program consisted of stretching movements and balance movements.

Exercise intervention

Eligibility Criteria

Age40 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 40 - 59 (middled aged women)
  • Those who have no difficulties in daily living
  • Those who engage in sedentary activities most of the day
  • Willing to commit throughout the study

You may not qualify if:

  • Antibiotics medication in the last month.
  • Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Park J, Kim J, Kang J, Choi J, Kim JE, Min KJ, Choi SW, Cho JY, Lee M, Choi JY. A 6-month exercise intervention clinical trial in women: effects of physical activity on multi-omics biomarkers and health during the first wave of COVID-19 in Korea. BMC Sports Sci Med Rehabil. 2024 Jan 29;16(1):30. doi: 10.1186/s13102-024-00824-6.

    PMID: 38287431DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ji-Yeob Choi

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 3, 2023

Study Start

May 10, 2019

Primary Completion

February 8, 2022

Study Completion

February 8, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)