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

NCT ID: NCT00813540

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Exercise

Group Type: EXPERIMENTAL

Exercise Training

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual Care

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Usual Care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry Courneya, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

AHS Cancer Control Alberta

Locations

Cross Cancer Institue

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

G1-23950

Identifier Type: -

Identifier Source: org_study_id