DNA MethylationGEMNCT02032628
DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise
A study testing Exercise in people with DNA Methylation, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women. Specific aim 2. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- DNA Methylation
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age 30-45
- Sedentary (i.e., < 40 minutes per week of moderate physical activity in the past 6-months; this criterion will be relaxed to <60 minutes per week if it limits enrollment)
- Menstruating regularly (not amenorrheic or dysmenorrheic)
- Non-smokers
- Willing to accept random assignment to condition
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- Willing to provide blood and saliva samples for epigenetic analysis
- Willing to and physically capable of safely engaging in moderate exercise activity (i.e., no injuries, physical impairments, or pre-existing contraindications) as assessed by a study physician
- Able to successfully complete a VO2max test without evidence of cardiac or other abnormalities
- Planning to remain in the Denver metro area for the next 10 months
Who cannot join
- Have a BMI > 35kg/m2
- Are diabetic or on a restricted diet
- Have uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg (to be assessed during physical exam, not on phone screen). (Participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care physician with initiation or adjustment of anti-hypertensive medications)
- Have a cardiovascular or respiratory disease including subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the maximal exercise test (VO2max). (Participants who do not meet these criteria at first screening will be re-evaluated; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist)
- Have a history of breast neoplasia
- Are currently receiving treatment for any type of cancer
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- Are on psychotropic medications
- Are currently under treatment for any psychiatric disorder
- Are currently under treatment for alcohol or drug abuse
- Are currently pregnant or attempting to become pregnant in the next 6-months
Trial locations and contacts
1 site in 1 country.
United States1 site
Image Lab/ University of Colorado Denver
Aurora, Colorado, 80045
About this study
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.
Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.
Read the detailed description
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.
- Hypothesis 1: The investigators predict that there will be an interaction between intensity and duration characterized by a dose-dependent response to total exercise volume, such that women will experience the greatest improvements in methylation at high intensity/high duration (16.4 kcal/kg/week) and the least improvements in methylation at low intensity/low duration (5.6 kcal/kg/week).
- Hypothesis 2: The investigators predict that there will be a main effect of exercise duration, such that women exercising for 40 minutes/session, 4 sessions per week will show more improvement in DNA methylation compared with women exercising for 20 minutes/session, 4 sessions per week.
- Hypothesis 3: The investigators predict that there will be a main effect of exercise intensity, such that women exercising at 75% of VO2max will show more improvement in DNA methylation compared with women exercising at 55% of VO2max.
Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.
- Hypothesis 4: At six months following the end of supervised exercise, the investigators will assess the influence of the different levels of initial training and the passage of time on DNA methylation, covarying whether or not participants continued to exercise. It is predicted that the highest volume group will show the greatest persistence of positive changes in DNA methylation. Alternatively, it is possible that all four groups will return to baseline methylation levels of methylation, and there will be no difference in methylation at 6 months following the end of supervised exercise.
- Conditions
- DNA Methylation
- Being tested
- Exercise
- Keywords
- epigenetics, cancer, exercise, intensity, duration
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called GEM
The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity/Longer Duration | Experimental | Exercise at higher intensity (~75% of VO2max) for 40 minute bouts 4 times per week Receives: Behavioral: Exercise |
| High Intensity/Lower Duration | Experimental | Exercise at high intensity (~75% of VO2max) for 20 minute bouts 4 times per week Receives: Behavioral: Exercise |
| Lower Intensity/Higher Duration | Experimental | Exercise at lower intensity (~55% of VO2max) for 40 minute bouts 4 times per week Receives: Behavioral: Exercise |
| Low Intensity/Low Duration | Experimental | Exercise at lower intensity (~55% of VO2max) for 20 minute bouts 4 times per week Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA METHYLATION
Measured: 4 months post-exercise initiation and 6 months after the end of the exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DNA MethylationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
- Investigators
- Angela Bryan, PhD, Principal investigator, University of Colorado, BoulderWendy kohrt, PhD, Principal investigator, UColoradoDenver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032628
- Sponsor's protocol ID
- PQA-5
- Other IDs
- 1R01CA179963-01
- Acronym
- GEM
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2013
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillman AS, Stevens CJ, Bryan AD. Women's exercise identity increases after a 16-week exercise RCT and is linked to behavior maintenance at follow-up. Psychol Sport Exerc. 2021 May;54:101888. doi: 10.1016/j.psychsport.2021.101888. Epub 2021 Jan 12.
PubMed 33633498Stevens CJ, Gillman AS, Giordano GR, Bryan AD. Modeling longitudinal variation in affective response to exercise across a 16-week randomized control trial (RCT). Health Psychol. 2021 Dec;40(12):928-939. doi: 10.1037/hea0001023. Epub 2020 Sep 24.
PubMed 32969699
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise
- ClinicalTrials.gov ID
- NCT02032628
- Acronym / sponsor ID
- GEM / PQA-5
- Conditions
- DNA Methylation
- Keywords
- epigenetics, cancer, exercise, intensity, duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 10 Jan 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.
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.
Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.
Detailed description
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.
- Hypothesis 1: The investigators predict that there will be an interaction between intensity and duration characterized by a dose-dependent response to total exercise volume, such that women will experience the greatest improvements in methylation at high intensity/high duration (16.4 kcal/kg/week) and the least improvements in methylation at low intensity/low duration (5.6 kcal/kg/week).
- Hypothesis 2: The investigators predict that there will be a main effect of exercise duration, such that women exercising for 40 minutes/session, 4 sessions per week will show more improvement in DNA methylation compared with women exercising for 20 minutes/session, 4 sessions per week.
- Hypothesis 3: The investigators predict that there will be a main effect of exercise intensity, such that women exercising at 75% of VO2max will show more improvement in DNA methylation compared with women exercising at 55% of VO2max.
Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.
- Hypothesis 4: At six months following the end of supervised exercise, the investigators will assess the influence of the different levels of initial training and the passage of time on DNA methylation, covarying whether or not participants continued to exercise. It is predicted that the highest volume group will show the greatest persistence of positive changes in DNA methylation. Alternatively, it is possible that all four groups will return to baseline methylation levels of methylation, and there will be no difference in methylation at 6 months following the end of supervised exercise.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Intensity/Longer Duration | Experimental | Behavioral: ExerciseExercise at higher intensity (~75% of VO2max) for 40 minute bouts 4 times per week |
| High Intensity/Lower Duration | Experimental | Behavioral: ExerciseExercise at high intensity (~75% of VO2max) for 20 minute bouts 4 times per week |
| Lower Intensity/Higher Duration | Experimental | Behavioral: ExerciseExercise at lower intensity (~55% of VO2max) for 40 minute bouts 4 times per week |
| Low Intensity/Low Duration | Experimental | Behavioral: ExerciseExercise at lower intensity (~55% of VO2max) for 20 minute bouts 4 times per week |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female
- Age 30-45
- Sedentary (i.e., < 40 minutes per week of moderate physical activity in the past 6-months; this criterion will be relaxed to <60 minutes per week if it limits enrollment)
- Menstruating regularly (not amenorrheic or dysmenorrheic)
- Non-smokers
Key exclusion criteria (10 listed)
- Have a BMI > 35kg/m2
- Are diabetic or on a restricted diet
- Have uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg (to be assessed during physical exam, not on phone screen). (Participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care physician with initiation or adjustment of anti-hypertensive medications)
- Have a cardiovascular or respiratory disease including subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the maximal exercise test (VO2max). (Participants who do not meet these criteria at first screening will be re-evaluated; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist)
- Have a history of breast neoplasia
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 |
|---|---|---|
| ExerciseAlso: GEMThe investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter. | Behavioural | High Intensity/Longer Duration, High Intensity/Lower Duration, Low Intensity/Low Duration, Lower Intensity/Higher Duration |
Primary outcome
DNA METHYLATION
Time frame: 4 months post-exercise initiation and 6 months after the end of the exercise intervention
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 1 Aug 2023.
- Derived from this study: PubMed 33633498Gillman AS, Stevens CJ, Bryan AD. Women's exercise identity increases after a 16-week exercise RCT and is linked to behavior maintenance at follow-up. Psychol Sport Exerc. 2021 May;54:101888. doi: 10.1016/j.psychsport.2021.101888. Epub 2021 Jan 12.
- Derived from this study: PubMed 32969699Stevens CJ, Gillman AS, Giordano GR, Bryan AD. Modeling longitudinal variation in affective response to exercise across a 16-week randomized control trial (RCT). Health Psychol. 2021 Dec;40(12):928-939. doi: 10.1037/hea0001023. Epub 2020 Sep 24.
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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.
Angela Bryan, PhD principal investigator
University of Colorado, Boulder
Wendy kohrt, PhD principal investigator
UColoradoDenver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with DNA Methylation, run by University of Colorado, Boulder at 1 site in United States.
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 10 inclusion and 10 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 1 Aug 2023. 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 United States. 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?
DNA METHYLATION (time frame: 4 months post-exercise initiation and 6 months after the end of the exercise intervention). 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 NCT02032628, which also lists 2 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 1 Aug 2023.