An interventional study of Exercise in Rectal Cancer, sponsored by University of Ottawa. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by University of Ottawa · Not applicable, Interventional, and Supportive care
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:
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
Browse Rectal Neoplasms studies →University of Ottawa is the lead sponsor of 123 studies on the registry; 33 are open to participants now.
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Exclusion criteria are:
Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
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.
Recruitment Rates
The number of eligible participants who enrol in the study out of the number who are referred.
Time frame: Through study completion, an average of 12 weeks
Retention Rates
The number of participants completing the intervention and all scheduled assessments.
Time frame: Through study completion, an average of 12 weeks
Adherence Rates
The number of exercise sessions completed out of 36.
Time frame: Through study completion, an average of 12 weeks
Number of Participants with Adverse Events
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.
Time frame: Through study completion, an average of 12 weeks
Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)
Change in self-reported quality of life from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)
Change in self-reported cognitive function from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)
Change in self-reported fatigue from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Change in self-reported affect from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Resting Heart Rate: Heart Rate Monitor (Polar A300)
Change in resting heart rate from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor)
Change in resting blood pressure from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Body Mass Index: Tanita Scale (TBF-310 GS)
Change in body mass index from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 12)
Socio-Demographic and Medical Information Questionnaire
The socio-demographic and medical information collected will be used to describe the sample.
Time frame: Baseline (week 0)
Plan to share: No
This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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