HealthyNCT02241850
Genetic Polymorphisms Affecting Effect of High Intensity Training
A study testing High intensity training in people with Healthy, run by Kyunghee University Medical Center.
Trial summary
The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High intensity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 30 to 60, healthy male subjects (at screening)
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Who cannot join
- Volunteer who has past or present history of any diseases following below; liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
- Subject who already participated in other trials in 30 days
- Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
- Subject who smokes an average of 20 cigarettes/day or drink > 5 cups of coffee
About this study
Official title: Assessment of Genetic Polymorphisms Affecting Effect of High Intensity Training in Korean Healthy Volunteers
The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.
- Conditions
- Healthy
- Being tested
- High intensity training
- Keywords
- High Intensity Training, Genetic Polymorphisms, Genome Wide association study, Single Nucleotide Polymorphism genotype, Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity trainingOther
9 weeks of supervised high intensity training
| Study group | Role | What they receive |
|---|---|---|
| High intensity training | Other | 9 weeks of supervised training Receives: Other: High intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal oxygen uptake
Measured: Baseline and after 6, 9 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Sung-Vin Yim, Kyunghee University Medical Center
- Investigators
- Sung-Vin Yim, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241850
- Sponsor's protocol ID
- DW-HIT01
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoo J, Kim BH, Kim SH, Kim Y, Yim SV. Genetic polymorphisms to predict gains in maximal O2 uptake and knee peak torque after a high intensity training program in humans. Eur J Appl Physiol. 2016 May;116(5):947-57. doi: 10.1007/s00421-016-3353-7. Epub 2016 Mar 21.
PubMed 27001664
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Genetic Polymorphisms Affecting Effect of High Intensity Training in Korean Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02241850
- Acronym / sponsor ID
- DW-HIT01
- Conditions
- Healthy
- Keywords
- High Intensity Training, Genetic Polymorphisms, Genome Wide association study, Single Nucleotide Polymorphism genotype, Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High intensity training | Other | Other: High intensity training9 weeks of supervised training |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 30 to 60, healthy male subjects (at screening)
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Key exclusion criteria (4 listed)
- Volunteer who has past or present history of any diseases following below; liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
- Subject who already participated in other trials in 30 days
- Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
- Subject who smokes an average of 20 cigarettes/day or drink > 5 cups of coffee
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 |
|---|---|---|
| High intensity training9 weeks of supervised high intensity training | Other | High intensity training |
Primary outcome
Change of maximal oxygen uptake
Time frame: Baseline and after 6, 9 weeks of training
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 16 Sep 2014.
- Derived from this study: PubMed 27001664Yoo J, Kim BH, Kim SH, Kim Y, Yim SV. Genetic polymorphisms to predict gains in maximal O2 uptake and knee peak torque after a high intensity training program in humans. Eur J Appl Physiol. 2016 May;116(5):947-57. doi: 10.1007/s00421-016-3353-7. Epub 2016 Mar 21.
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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.
Sung-Vin Yim, MD, PhD principal investigator
Kyung Hee University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing High intensity training in people with Healthy, run by Kyunghee University Medical Center.
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 2 inclusion and 4 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 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of maximal oxygen uptake (time frame: Baseline and after 6, 9 weeks of training). 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 NCT02241850, which also lists 1 linked publication.
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 16 Sep 2014.