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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813540
• Other study ID #: G1-23950
• 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

• Colonic Neoplasms

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