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not enough patients consented during the funding period
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 30 minutes walking | Experimental | First Step program with 30 minutes of walking and 10,000 steps per day for 3 months. |
|
| Arm B: 60 minutes walking | Experimental | First Step program with 60 minutes of walking and 13,000 steps per day for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. | Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Y. Wolin, ScD, FACSM | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22808053 | Derived | Wolin KY, Fagin C, James AS, Early DS. Promoting physical activity in patients with colon adenomas: a randomized pilot intervention trial. PLoS One. 2012;7(7):e39719. doi: 10.1371/journal.pone.0039719. Epub 2012 Jul 13. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| D015444 | Exercise |
| D009043 | Motor Activity |