Feasibility and Efficacy of Interval Walking in Patients With Colorectal Cancer

Summary

Background: The level physical exercise is strongly associated with colorectal cancer risk in the general population, and recent data shows that physical activity after a colorectal cancer diagnosis is inversely associated with mortality risk, indication the physical exercise can protect against disease progression. However, few studies have successfully performed exercise interventions in patients with colorectal cancer, and the potential mechanisms responsible for the tumor suppressing effects of exercise remain poorly explored.

Purpose: To investigate interval-walking, delivered by the InterWalk smart phone application as exercise-modality in patients with colorectal cancer. Specifically it is the aim to explore if InterWalk is safe and feasible as well as effective to improve cardio-metabolic health profile.

Subjects: Colorectal cancer patients, stage I-III, who are at least one month post-surgery and have concluded any adjuvant chemotherapy treatment, are eligible for inclusion. Exclusion criteria are: age \<18; any major surgical procedure planned within 6 months after inclusion; pregnancy; ongoing treatment for any known malignancy; performance status \> 1; unable to read and understand Danish

Methods: 40 colorectal cancer patients are included and randomized to I) InterWalk or II) waiting list control for 24 weeks. Patients are evaluated at baseline, week 12 and week 24 by assessment measures to determine cardio-metabolic health profile and other relevant study outcomes, including: cardiopulmonary exercise test (VO2peak); anthropometrics; blood pressure; resting heart rate; body composition; health related quality of life questionnaires; plasma concentration levels of cholesterol, triglycerides, insulin, glucose and inflammatory cytokines; insulin sensitivity; and cognitive function.

Conditions

• Colorectal Cancer

Interventions

BEHAVIORAL

InterWalk

Patient allocated to the InterWalk-group will be introduced to the InterWalk app, including instructions on how to down load and use the application. and prescribed to perform Interval Walking for 150 min per week

BEHAVIORAL

Waiting list control

Patients allocated to the waiting-list control group will be prescribed standard guidelines for the patient group, but will be asked not to download and use the InterWalk app (which is freely available) for the first 12 weeks of the study period. After the first 12 weeks (the control period), patients in this group will receive the same instructions for download and use of the InterWalk app in the following 12 weeks

Sponsors & Collaborators

• Hvidovre University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Jesper F Christensen, PhD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2017-09-22

Completion

2017-09-22

Countries

• Denmark

Study Locations