NCT04985006

Brief Summary

Aerobic exercise has been shown to trigger a variety of body responses which then trigger physiological adaptations. One of the physiological adaptations that occur is an increase in mitochondrial biogenesis. Mitochondria are organelles in cells that play a role in providing energy. An increase in the number of mitochondria will increase the supply of energy for muscle cell contraction, so that muscles do not get tired easily. Mitochondrial biogenesis is known to be regulated by Peroxisome proliferator-activated receptor gamma co-activator-1 alpha (PGC-1α), by inducing transcription of genes encoded by the nucleus and mitochondria. Peroxisome proliferator-activated receptor gamma co-activator-1 alpha is a protein which encoded by the PPARGC1A gene. PPARGC1A gene expression itself can be influenced by microRNA, a short non-coding RNA that can regulate gene expression by suppressing or degrading the target gene. In vitro studies show that PPARGC1A gene is a direct gene target of microRNA (miR)-23a. In human studies, aerobic exercise has been shown to reduce miR-23a levels in human muscles immediately after exercise. Another study found an increase in muscle PGC-1 alpha levels after exercise. In addition to being detectable in muscle, both miR-23a and PGC-1 alpha can be measured in blood plasma. However, whether exercise can reduce miR-23a levels while increasing PGC-1 alpha levels in circulation, still needs further research. Therefore, this study aims to examine whether aerobic exercise will reduce miR-23a levels and PGC-1 alpha levels in plasma. In addition, this study will also compare whether exercise intensity affects the expression of miR-23a and PGC-1 alpha. In this study, measurements will be made on blood plasma to reduce the level of invasiveness. Subjects will be asked to come to the laboratory three times. The first meeting consisted of an examination, while in the second and third meetings the subjects would be asked to run at a moderate or high intensity. Blood sampling will be done before and after 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
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

July 26, 2021

Last Update Submit

September 15, 2021

Conditions

Keywords

microRNAexerciseaerobic exerciseepigeneticmitochondrial biogenesis

Outcome Measures

Primary Outcomes (2)

  • miR-23a level in plasma

    microRNA level will be measured using qpCR. Ce-miR-39 spike in control will be added for normalization. Quantification of the microRNA level will be expressed as 2-\[(CT microRNA)-(CT cel-miR-39)\].

    Before and immediately after exercise

  • PGC 1 alpha level in plasma

    PGC 1 alpha level will be measured using ELISA. The result will be obtained in nanograms.

    Before and immediately after exercise

Study Arms (2)

Moderate intensity aerobic exercise

EXPERIMENTAL

each subject will undergo running in medium intensity.

Behavioral: running at moderate intensity

High intensity aerobic exercise

ACTIVE COMPARATOR

each subject will undergo running in high intensity.

Behavioral: running at high intensity

Interventions

intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 50-59% Heart rate reserve (HRR) for 30 minutes from the time the target intensity is reached.

Moderate intensity aerobic exercise

intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 70-75% HRR for 30 minutes from the time the target intensity is reached.

High intensity aerobic exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • BMI \<30
  • systolic blood pressure \<140 mmHg
  • diastolic blood pressure \<90 mmHg
  • have no chronic disease
  • have no complaints related to the musculoskeletal, respiratory and cardiovascular systems
  • willing to to come to the laboratory
  • willing to sign the informed consent form

You may not qualify if:

  • suffer from chronic disease
  • have complaints related to the musculoskeletal, respiratory, and cardiovascular systems
  • have a history of smoking, both active and passive in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiology. Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rahmaningsih M Sabirin, MD, M.Sc

    Department of Physiology. Faculty of Medicine, Public Health and Nursing. Universitas Gadjah Mada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome measurement (microRNA measurement using qPCR and PGC 1 alpha measurement using ELISA) will be done by professional laboratory assistant who is blind about the intervention given to the participant.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All the participant will be asked to run in moderate and high intensity in random order. The interval between the first exercise and the next is 48 hours to 14 days.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, Doctoral students

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 2, 2021

Study Start

October 1, 2020

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations