Exercise for Adults Diagnosed With Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT03049124
- Lead Sponsor
- University of Ottawa
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise Exercise Participants will be asked to complete a 12-week exercise intervention and all study assessments.
- Primary Outcome Measures
Name Time Method Recruitment Rates Through study completion, an average of 12 weeks The number of eligible participants who enrol in the study out of the number who are referred.
Retention Rates Through study completion, an average of 12 weeks The number of participants completing the intervention and all scheduled assessments.
Adherence Rates Through study completion, an average of 12 weeks The number of exercise sessions completed out of 36.
Number of Participants with Adverse Events Through study completion, an average of 12 weeks The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Ottawa
🇨🇦Ottawa, Ontario, Canada