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

NCT00813540 | Completed Phase 2

• 1 other identifier: G1-23950
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Colonic Neoplasms; Aerobic Exercise; Weight Lifting; Body Composition

Outcome Measures

Primary Outcomes (1)

• Safety (Monitoring for Adverse Events)

  12 Weeks

Secondary Outcomes (3)

• Change in Aerobic Capacity

  Baseline and 12 Weeks

• Change in body composition

  Baseline and 12 Weeks

• Feasibility (Adherence to the exercise training program)

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Exercise

Behavioral: Exercise Training

2

OTHER

Usual Care, no intervention

Other: Usual Care

Interventions

Exercise Training 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.

1

Usual Care OTHER

Usual Care

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institue

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerry Courneya, Ph.D.

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 23, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 11, 2016

Record last verified: 2012-04

Locations

CA (1)