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DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise (GEM)

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ClinicalTrials.gov Identifier: NCT02032628
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Colorado, Boulder

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date October 12, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
DNA METHYLATION [ Time Frame: 4 months post-exercise initiation and 6 months after the end of the exercise intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02032628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise
Official Title  ICMJE DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE DNA Methylation
Intervention  ICMJE Behavioral: Exercise
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.
Other Name: GEM
Study Arms  ICMJE
  • Experimental: High Intensity/Longer Duration
    Exercise at higher intensity (~75% of VO2max) for 40 minute bouts 4 times per week
    Intervention: Behavioral: Exercise
  • Experimental: High Intensity/Lower Duration
    Exercise at high intensity (~75% of VO2max) for 20 minute bouts 4 times per week
    Intervention: Behavioral: Exercise
  • Experimental: Lower Intensity/Higher Duration
    Exercise at lower intensity (~55% of VO2max) for 40 minute bouts 4 times per week
    Intervention: Behavioral: Exercise
  • Experimental: Low Intensity/Low Duration
    Exercise at lower intensity (~55% of VO2max) for 20 minute bouts 4 times per week
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2016)
276
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
240
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032628
Other Study ID Numbers  ICMJE PQA-5
1R01CA179963-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Boulder
Study Sponsor  ICMJE University of Colorado, Boulder
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Angela Bryan, PhD University of Colorado, Boulder
Principal Investigator: Wendy kohrt, PhD UColoradoDenver
PRS Account University of Colorado, Boulder
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP