DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise

NCT02032628 | Completed DMC

• 2 other identifiers: PQA-51R01CA179963-01
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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. 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

DNA Methylation

Keywords

epigenetics; cancer; exercise; intensity; duration

Outcome Measures

Primary Outcomes (1)

• DNA METHYLATION

  4 months post-exercise initiation and 6 months after the end of the exercise intervention

Study Arms (4)

High Intensity/Longer Duration

EXPERIMENTAL

Exercise at higher intensity (\~75% of VO2max) for 40 minute bouts 4 times per week

Behavioral: Exercise

High Intensity/Lower Duration

EXPERIMENTAL

Exercise at high intensity (\~75% of VO2max) for 20 minute bouts 4 times per week

Behavioral: Exercise

Lower Intensity/Higher Duration

EXPERIMENTAL

Exercise at lower intensity (\~55% of VO2max) for 40 minute bouts 4 times per week

Behavioral: Exercise

Low Intensity/Low Duration

EXPERIMENTAL

Exercise at lower intensity (\~55% of VO2max) for 20 minute bouts 4 times per week

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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.

Also known as: GEM

High Intensity/Longer Duration; High Intensity/Lower Duration; Low Intensity/Low Duration; Lower Intensity/Higher Duration

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Image Lab/ University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 33633498 DERIVED

• Stevens 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Angela Bryan, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Wendy kohrt, PhD

  UColoradoDenver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)