NCT03049124

Exercise for Adults Diagnosed With Rectal Cancer

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Ottawa · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered. The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible. The specific objectives are to: 1. Test the feasibility and safety of a 12-week exercise intervention; 2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes); 3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than \< 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than \< 60% of heart rate reserve) component.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-12-04
• Completion: 2019-12-04
• First posted: 2017-02-09
• Last updated: 2020-03-10

Locations

1 site across 1 country: Canada