Back to resultsThe Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Exercise Training
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Colonic Neoplasms focused on measuring Colonic Neoplasms, Aerobic Exercise, Weight Lifting, Body Composition
Eligibility 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
Sites / Locations
- Cross Cancer Institue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Exercise
Usual Care, no intervention
Outcomes
Primary Outcome Measures
Safety (Monitoring for Adverse Events)
Secondary Outcome Measures
Change in Aerobic Capacity
Change in body composition
Feasibility (Adherence to the exercise training program)
Full Information
NCT ID
NCT00813540
First Posted
December 19, 2008
Last Updated
March 10, 2016
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT00813540
Brief Title
The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors
Official Title
The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colonic Neoplasms, Aerobic Exercise, Weight Lifting, Body Composition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise
Arm Title
2
Arm Type
Other
Arm Description
Usual Care, no intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Safety (Monitoring for Adverse Events)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Aerobic Capacity
Time Frame
Baseline and 12 Weeks
Title
Change in body composition
Time Frame
Baseline and 12 Weeks
Title
Feasibility (Adherence to the exercise training program)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Courneya, Ph.D.
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institue
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors
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