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

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00813540
First received: December 19, 2008
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Colonic Neoplasms
 Behavioral: Exercise Training
Other: Usual Care
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Safety (Monitoring for Adverse Events) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Aerobic Capacity [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • Feasibility (Adherence to the exercise training program) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: March 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
2
Usual Care, no intervention
 Other: Usual Care
Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813540

Contacts
Contact: Christopher Sellar, M.Sc. (780) 492-2829 csellar@ualberta.ca

Locations
Canada, Alberta
Cross Cancer Institue Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Christopher Sellar, M.Sc.     (780) 492-2829     csellar@ualberta.ca    
Sub-Investigator: Heather J Au, M.D            
Sub-Investigator: Gordon Bell, Ph.D            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Kerry Courneya, Ph.D. Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00813540     History of Changes
Other Study ID Numbers: G1-23950
Study First Received: December 19, 2008
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Colonic Neoplasms
Aerobic Exercise
Weight Lifting
Body Composition

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

ClinicalTrials.gov processed this record on May 23, 2013