Step Down Colon Cancer Risk
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|ClinicalTrials.gov Identifier: NCT01476631|
Recruitment Status : Terminated (not enough patients consented during the funding period)
First Posted : November 22, 2011
Last Update Posted : August 5, 2013
Hypothesis 1: Exercise will decrease serum markers in a dose response manner.
Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.
|Condition or disease||Intervention/treatment||Phase|
|Adenomatous Polyps||Behavioral: Walking||Not Applicable|
Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.
Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Arm A: 30 minutes walking
First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
Experimental: Arm B: 60 minutes walking
First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
- Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. [ Time Frame: 3 months ]Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.
- Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months. [ Time Frame: 3 months ]Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476631
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Kathleen Y. Wolin, ScD, FACSM||Washington University School of Medicine|