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Physical FitnessNCT04366479

Endurance Exercise on nrf2 mRNA Expression Gene and VO2max

A study testing Multistage Fitness Test in people with Physical Fitness, run by Hasanuddin University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Indonesian Hajj Health Officers have the responsibility and very important role in providing health services for Indonesian pilgrims during embarkation and debarkation. One of the main indicators of success is they have excellent physical fitness. Read more about this study

Who is it for?
Ages 30 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Physical Fitness
What is being tested?
Multistage Fitness Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndonesia
Study dates
8 May 2019to 8 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants from the Nurse profession aged 30 - 39 years
  • Pass the selection of candidates for Indonesian Hajj Health Officers
  • Understand the physical training program instructions in the rockport method
  • Willing to participate in activities and all research provisions

Who cannot join

  • Had a history of coronary heart disease,asthma
  • Not approved by the doctor to participate in the study due to a medical condition

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Makassar Center for Health Training

    Makassar, South Sulawesi, 90245

Other trials in Indonesia

About this study

Official title: Effect of Endurance Exercise on nrf2 mRNA Expression Gene and Physical Fitness (VO2max) of Indonesian Hajj Health Officers

Indonesian Hajj Health Officers have the responsibility and very important role in providing health services for Indonesian pilgrims during embarkation and debarkation. One of the main indicators of success is they have excellent physical fitness. This study aims to determine the effectiveness of an intervention program by comparing the results of (intervention) intervention groups, namely the effect of physical exercise interventions (endurance exercise) measured before and after the intervention. This research is an intervention study, and I understand that the process of taking blood can occur with fear, pain due to being pricked by a needle, can faint or be infected. However, previous blood pressure tests, sterile collection techniques and performed by experts, are very unlikely to cause side effects.

Read the detailed description

The investigators invite all Indonesian Hajj Health Officers candidates to participate in research on physical fitness (VO2max) which is an important part of providing Hajj health services in Saudi Arabia while they are on duty. I was involved in the RT-PCR examination and physical fitness test (VO2max) that was carried out before the intervention program and was briefed on the examination protocol before being tested. The consent form was given to me first to be handled. I was informed about the intervention process and the purpose of the research, as well as the confidentiality of the data, collected. And it was also stated that I would be allowed to withdraw from the research at any time without pressure and coercion from any party. The procedure investigators will do is take samples from prospective Indonesian Hajj Health Officers undergoing a series of anamneses and physical examinations by doctors, in the form of personal data, physical activities, general physical examinations including TB, BB, HR, RR, then performed the physical activity eligibility forms. Next, a 1 ml blood sample is taken into a purple test tube containing EDTA to prevent lysis. The blood sample is taken to the HUM-RC Makassar Biomolecular Biology laboratory and stored in a frozen cupboard, after which an initial physical fitness measurement (VO2max) test is carried out using the Multi Fitness Test (MFT) or Bleep Test to PRE TEST at the Health Training Center (Health Training Center) BBPK) Makassar, followed by running exercises intervention as far as 1600 meters 3 times a week duration of 20-30 each training session with a frequency of exercise 16 times 5 weeks according to a predetermined schedule, then conducted a physical fitness test (VO2max) using the same method when PRE TEST to POST TEST I, followed by 1 ml blood sampling at Sudiang Embarkation Hajj Makassar, then 1 week later physical fitness test (VO2max) to POST TEST II without blood sampling is taken again.

Participants (n = 30), measured physical fitness level (VO2max) using the Multistage Fitness Test (MFT) Bleep Test (level and feedback) method before being given intervention (pre-exercise), after that given a running intervention 1600 meters duration 20 -30 minutes each training session 3 times a week with a frequency of exercise16 times for 5 weeks, then physical fitness measurements (VO2max) → (post-exercise 1), then intermittent 1-week duration of physical fitness measurements (VO2max) again without intervention and blood sampling (post-exercise 2).

Participants only joined in one group will be given intervention for 5 weeks in the form of running 1600 meters duration of 20-30 minutes 3 times a week. It is important for the participants as well as for us to know which training methods are given. this information will be documented in our file, but the investigators will not see these files until after the research is complete. this is the best way the investigators have for testing without being influenced by what the investigators think or expect might happen.

The doctor in charge of research will always look after the participants very carefully during the study. If the investigators are worried about what is done, the investigators will find out how the level of physical fitness that participants get and make changes. If there is something the participant is worried about or is disturbing the Participant about the research, please talk to me or one of the other researchers.

In this study, the investigators did not use a placebo term, but the investigators still explained to participants in the world of research that the term placebo is known as clinical trials or interventions given to participants that are not genuine but fake. For good research, participants mustn't know whether the participants have been properly measured according to the criteria or not. This is one of the best ways the investigators have to find out what level of physical fitness the investigators are testing. No side effects might occur because the previous sample was very rigorously selected through analysis, physical examination and physical activity feasibility testing. If Participants find that Our interventions are very uncomfortable for participants, the investigators can use other exercise options more comfortably according to the available exercise choices.

The possibility of danger, risk, or side effects in this study is very small because the selection of samples is done very closely starting with anamnesis and head-to-toe physical examination and continued with a physical activity feasibility test (PAR-Q). If the physical fitness test occurs when there is suffocation, the researcher has prepared 2 medical staff who accompanied the subjects during the physical fitness test and also in this study the investigators prepared 2 clinics namely the Makassar BBPK Health Clinic which was used during the physical fitness pre-test and the Clinic Musytasyfa Health Makassar Haji Sudiang Dormitory that was used at the time of physical fitness post-test.

During the study, the investigators carried out a series of research processes as follows: Pre-exercise

  • In the first stage: Conducting anamneses and physical examinations by doctors, in the form of personal data, physical activity, general physical examination including Height, Weight, Heart Rate, Respiratory Rate, Blood Pressure (BP)
  • In the second stage: Completion of physical activity eligibility forms.
  • In the third step: a 1 ml blood sample is taken into a purple test tube containing EDTA to prevent lysis. The blood samples were taken to the Makassar HUM-RC Biomolecular Biology laboratory and stored in a frozen cupboard.
  • In the fourth step: Measurement of the initial physical fitness test (VO2max) using the Multi Fitness Test (MFT) or Bleep Test to PRE TEST at the Makassar Health Training Center (BBPK) Endurance Exercise
  • In the first stage: Selecting an exercise schedule according to the provisions of the study
  • In the second stage: Exercise choice I: Monday-Wednesday-Friday; Exercise choice II: Tuesday-Thursday-Saturday; Exercise choice III: Wednesday-Friday-Sunday
  • In the third stage: Document endurance exercises in the form of a video exercise Post Exercise I
  • In the first stage: Initial physical fitness test (VO2max) measurement using the Multi Fitness Test (MFT) or Bleep Test to POST TEST I at the Haji Sudiang Makassar Dormitory In the second stage: Recovery 1 hour after the physical fitness test In the third stage: Taking 1 ml of blood sample inserted in a purple test tube containing EDTA to prevent lysis. The blood samples were taken to the Makassar HUM-RC Biomolecular Biology laboratory and stored in a frozen cupboard.

Post Exercise II Measurement of the initial physical fitness test (VO2max) using the Multi Fitness Test (MFT) or Bleep Test to POST TEST II at the Makassar Sports Hall

Being tested
Multistage Fitness Test
Keywords
Endurance Exercise, Nuclear Respiratory Factor, Physical Fitness (VO2max)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multistage Fitness TestBehavioural

    Participants only joined in one group will be given intervention for 5 weeks in the form of running 1600 meters duration of 20-30 minutes 3 times a week. It is important for the participants as well as for us to know which training methods are given. this information will be documented in our file, but we will not see these files until after the research is complete. this is the best way we have for testing without being influenced by what we think or expect might happen.

Study groups in NCT04366479
Study groupRoleWhat they receive
intervention groupExperimentalThe study lasted for 5 weeks (1 month 7 days). During the research process, we monitor closely, especially the training schedule, implementation, and evaluation, directly and indirectly. Directly assisting participants to do endurance training activities, not directly monitoring via telephone or WhatsApp.
Receives: Behavioral: Multistage Fitness Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2max Measurement

    Aerobic capacity is also known as maximal oxygen uptake or maximum oxygen consumption (VO2max)

    Measured: 5 weeks

  2. Measurement of mRNA NRF2 Gene Expression

    RT-PCR analyzes human RNA in the nrf2 RNA sample as the target gene and GAPDH is selected as the housekeeping gene

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start8 May 2019
  3. Primary completion8 Oct 2019
  4. Study completion8 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This type of quasi-experimental research (quasy experiment) with pre-test and post-test research design with only control design.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04366479
Sponsor's protocol ID
HasanuddinU
Status last verified
Apr 2020
First submitted
17 Apr 2020
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vivian H. Heyward. (2016). Aerobic Capacity, Physical Fitness and VO2 Maxium Measurement. Advance Fitness Assessment & Exercise Prescription, 252(805), 2-5. https://www.biopac.com/wp-content/uploads/app252.pdf

  • Lockie RG, Dawes JJ, Moreno MR, Cesario KA, Balfany K, Stierli M, Dulla JM, Orr RM. Relationship Between the 20-m Multistage Fitness Test and 2.4-km Run in Law Enforcement Recruits. J Strength Cond Res. 2021 Oct 1;35(10):2756-2761. doi: 10.1519/JSC.0000000000003217.

    PubMed 31268997
  • Zhao XQ, Zhang YF, Xia YF, Zhou ZM, Cao YQ. Promoter demethylation of nuclear factor-erythroid 2-related factor 2 gene in drug-resistant colon cancer cells. Oncol Lett. 2015 Sep;10(3):1287-1292. doi: 10.3892/ol.2015.3468. Epub 2015 Jul 8.

    PubMed 26622665

Questions about this trial

What is this clinical trial studying?

A study testing Multistage Fitness Test in people with Physical Fitness, run by Hasanuddin University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2max Measurement (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04366479, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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