The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors

March 10, 2016 updated by: AHS Cancer Control Alberta

The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors: a Randomized Controlled Trial

Recent studies have suggested that individuals diagnosed with colon cancer who are inactive and/or overweight, may have poorer survival outcomes. Exercise training has been shown to improve fitness and body composition in other cancer survivor groups. The investigators hypothesize that an exercise training program will be a safe, feasible, and effective intervention to improve the fitness and body composition of a group of colon cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed Stage II or III colon cancer diagnosis
  • Less than or equal to 1 year since the completion of all adjuvant treatment
  • Negative Physical Activity Readiness Questionnaire (PAR-Q) or completed Physical Activity Readiness Medical Examination (PARmed-X) form
  • 18 years of age or older
  • Ability to understand and provide written informed consent in English
  • Willingness to be randomized
  • Willingness to complete outcome measures at each assessment time point
  • Available for the duration of study intervention period
  • Able to travel to our fitness centre 3/week for the study period

Exclusion Criteria:

  • Any absolute contraindication to to exercise testing or training
  • Evidence of active disease (metastatic, recurrent, or unresectable colon cancer)
  • Any uncontrolled medical condition or psychiatric illness that would prevent completion of the exercise program or interfere with the study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Exercise
Behavioral: Exercise Training
The exercise group will perform supervised stationary cycle ergometer exercise 3 times per week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 110% of the power output obtained at V02peak. Resistance training will be completed twice per week and will include exercises for all major muscle groups. The training will progress from 60% to 80% of 1RM over the course of the intervention.
Other: 2
Usual Care, no intervention
Other: Usual Care
Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (Monitoring for Adverse Events)
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Aerobic Capacity
Time Frame: Baseline and 12 Weeks
Baseline and 12 Weeks
Change in body composition
Time Frame: Baseline and 12 Weeks
Baseline and 12 Weeks
Feasibility (Adherence to the exercise training program)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

  • Principal Investigator: Kerry Courneya, Ph.D., AHS Cancer Control Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G1-23950

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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