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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00813540
Other study ID # G1-23950
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 19, 2008
Last updated March 10, 2016
Start date March 2009
Est. completion date May 2012

Study information

Verified date April 2012
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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:
Usual Care
Usual Care

Locations

Country Name City State
Canada Cross Cancer Institue Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety (Monitoring for Adverse Events) 12 Weeks Yes
Secondary Change in Aerobic Capacity Baseline and 12 Weeks No
Secondary Change in body composition Baseline and 12 Weeks No
Secondary Feasibility (Adherence to the exercise training program) 12 weeks Yes
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