Clinical trial · Interventional
DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise
NCT02032628CI-TRIAL-00068441GEMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DNA Methylation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- High Intensity/Longer Duration
- description
- Exercise at higher intensity (\~75% of VO2max) for 40 minute bouts 4 times per week
- interventionNames
- Behavioral: Exercise
- type
- EXPERIMENTAL
- label
- High Intensity/Lower Duration
- description
- Exercise at high intensity (\~75% of VO2max) for 20 minute bouts 4 times per week
- interventionNames
- Behavioral: Exercise
- type
- EXPERIMENTAL
- label
- Lower Intensity/Higher Duration
- description
- Exercise at lower intensity (\~55% of VO2max) for 40 minute bouts 4 times per week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (2)
- DERIVEDGillman 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. PMID 33633498
- DERIVEDStevens 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. PMID 32969699