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

Sponsor:	Alberta Health Services
Information provided by (Responsible Party):	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00813540

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 II Phase III

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:

MedlinePlus related topics: Cancer Exercise and Physical Fitness

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:	February 2012
Estimated Primary Completion Date:	February 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

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:	September 20, 2011
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 February 09, 2012