NCT01476631

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

November 9, 2011

Last Update Submit

August 2, 2013

Conditions

Adenomatous Polyps

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

Arm A: 30 minutes walking

EXPERIMENTAL

First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.

Behavioral: Walking

Arm B: 60 minutes walking

EXPERIMENTAL

First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.

Behavioral: Walking

Interventions

WalkingBEHAVIORAL

* 7 days prior to baseline participants must wear a blinded pedometer * At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale.

Arm A: 30 minutes walkingArm B: 60 minutes walking

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 22808053DERIVED

Related Links

MeSH Terms

Conditions

Adenomatous Polyps

Interventions

Walking

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Kathleen Y. Wolin, ScD, FACSM

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 22, 2011

Study Start

November 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

US(1)