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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Conditions
- Physical Fitness
- 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 group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The 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.
VO2max Measurement
Aerobic capacity is also known as maximal oxygen uptake or maximum oxygen consumption (VO2max)
Measured: 5 weeks
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.
- First posted29 Apr 2020
- Study start8 May 2019
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH
- Responsible party
- Principal investigator, Ismail Ahmad, Hasanuddin University
- Investigators
- Mochammad Hatta, Profesor, Principal investigator, Department of Biomolecular Medicine, Hasanuddin University Makassar
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 31268997Zhao 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endurance Exercise on nrf2 mRNA Expression Gene and Physical Fitness (VO2max) of Indonesian Hajj Health Officers
- ClinicalTrials.gov ID
- NCT04366479
- Acronym / sponsor ID
- HasanuddinU
- Conditions
- Physical Fitness
- Keywords
- Endurance Exercise, Nuclear Respiratory Factor, Physical Fitness (VO2max)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Collaborators
- Indonesia-MoH
- Study start
- 8 May 2019 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This type of quasi-experimental research (quasy experiment) with pre-test and post-test research design with only control design.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Multistage Fitness TestThe 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. |
Who may qualify
- Ages
- 30 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Had a history of coronary heart disease,asthma
- Not approved by the doctor to participate in the study due to a medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multistage Fitness TestParticipants 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. | Behavioural | intervention group |
Primary outcome
VO2max Measurement
Time frame: 5 weeks
Aerobic capacity is also known as maximal oxygen uptake or maximum oxygen consumption (VO2max)
Measurement of mRNA NRF2 Gene Expression
Time frame: 5 weeks
RT-PCR analyzes human RNA in the nrf2 RNA sample as the target gene and GAPDH is selected as the housekeeping gene
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Results publicationVivian 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
- Results publication: PubMed 31268997Lockie 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.
- Results publication: PubMed 26622665Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mochammad Hatta, Profesor principal investigator
Department of Biomolecular Medicine, Hasanuddin University Makassar
1 site in 1 country: see every site and its status.
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.