Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT00668161
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Completed a colonoscopy within the past 36 months
* Ages 40-75 years at time of identification
* Sedentary activity pattern
* Gives informed consent, agrees to be randomly assigned
* Able to perform all study requirements, able to follow directions and complete forms
Exclusion Criteria:
* Colorectal cancer at any time; any other invasive cancer within the past 10 years (simple basal or squamous cell carcinoma okay)
* Plans to leave Western Washington during the follow-up period
* Morbidly obese (BMI \> 41), weight loss of \> 10 pounds in the previous 3 months
* Familial polyposis, Gardner's syndrome, or other known familial colorectal cancer syndrome
* Ulcerative colitis or short bowel
* "Excessive"(\> 3 x week) laxative or enema use that might interfere with rectal crypt studies
* Current use of certain medications likely to interfere with success of the intervention, or with outcomes measures (for example, anticoagulants because of risk from colorectal biopsy, diet medications within past 6 months)
* Diabetes mellitus or fasting glucose \> 140
* Hemochromatosis- if diagnosed by physician
* Abnormal screening labs (hematocrit \< 32 or \> 48, white blood cells \< 3.0 or \> 15.0, potassium \< 3.5 or \> 5.3, fasting glucose \> 140, creatinine \> 2.0), or abnormalities on screening physical exam judged by study physicians to contraindicate participation in an exercise program
* Contraindications for entry into a training program 131 including: unstable angina, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension (\>20 mm fall in systolic), moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, third degree heart block, pericarditis, myocarditis, pulmonary/systemic embolism within the past 6 months, thrombophlebitis, ST displacement \> 3 mm at rest, history of cardiac arrest)
* Contraindications for exercise testing 131 including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality
* Meets criteria to stop screening exercise test 131 as decided by overseeing physician
* Volunteering in order to lose weight; alcohol or drug abuse, significant mental or emotional problems such as would interfere with compliance (as assessed by study staff impression)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00668161
Study Brief:
Protocol Section:
NCT00668161