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The Washington University

Status

Terminated

Conditions

Adenomatous Polyps

Treatments

Behavioral: Walking

Study type

Interventional

Funder types

Other

Identifiers

NCT01476631
201105308

Details and patient eligibility

About

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.

Full description

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.

Enrollment

17 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged 50 to 80
  • no personal cancer history
  • found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
  • no contraindications to beginning an exercise program
  • no previous diagnosis of familial polyposis syndromes
  • no previous diagnosis of ulcerative colitis or Crohn's disease;

Exclusion criteria

  • Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Arm A: 30 minutes walking
Experimental group
Description:
First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
Treatment:
Behavioral: Walking
Arm B: 60 minutes walking
Experimental group
Description:
First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
Treatment:
Behavioral: Walking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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