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OpenTrials
Completed

NCT Number: NCT00813540

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cross Cancer Institue

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Other

Usual Care

Primary outcomes

  1. Safety (Monitoring for Adverse Events)

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in Aerobic Capacity

    Time frame: Baseline and 12 Weeks

  2. Change in body composition

    Time frame: Baseline and 12 Weeks

  3. Feasibility (Adherence to the exercise training program)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2008
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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