Exercise for Adults Diagnosed With Rectal Cancer

University of Ottawa

Status

Withdrawn

Conditions

Rectal Cancer

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03049124

RectalCaEx-JB-MV-KC

Details and patient eligibility

About

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:

Test the feasibility and safety of a 12-week exercise intervention;
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);
Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are:

Men and women 18 to 85 years of age;
Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;
Able to read/understand English or French;
Ambulatory;
Live <50km of the University of Ottawa;
Approval of healthcare provider to participate in the intervention.

Exclusion criteria are:

Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
The use of supplemental oxygen;
Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
Hip fracture, hip or knee replacement in the past 6 months;
Impairments requiring mobility aids;
Stage V cancer;
Prior cancer diagnosis, excluding non-melanoma skin cancer;
Participating in another exercise trial;
Unwilling/unable to give informed consent.

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.