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Trial record 9 of 603 for:    "Colonic Neoplasms"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00813540
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : March 11, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Behavioral: Exercise Training Other: Usual Care Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors: a Randomized Controlled Trial
Study Start Date : March 2009
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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.
Usual Care, no intervention
Other: Usual Care
Usual Care

Outcome Measures

Primary Outcome Measures :
  1. Safety (Monitoring for Adverse Events) [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Change in Aerobic Capacity [ Time Frame: Baseline and 12 Weeks ]
  2. Change in body composition [ Time Frame: Baseline and 12 Weeks ]
  3. Feasibility (Adherence to the exercise training program) [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00813540

Canada, Alberta
Cross Cancer Institue
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Principal Investigator: Kerry Courneya, Ph.D. AHS Cancer Control Alberta
More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00813540     History of Changes
Other Study ID Numbers: G1-23950
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: April 2012

Keywords provided by AHS Cancer Control Alberta:
Colonic Neoplasms
Aerobic Exercise
Weight Lifting
Body Composition

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases