Feasibility and Efficacy of Interval Walking in Patients With Colorectal Cancer

NCT02403024 | Completed

• 1 other identifier: I-Walk-CRC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Colon cancer; rectal cancer; exercise; physical activity; metabolic health

Outcome Measures

Primary Outcomes (1)

• Change in VO2peak

  On a stationary bicycle, the participants perform 3 minutes warm up on 70 Watt followed by a step-by-step incremental test with workload increasing by 20 Watt every minute until exhaustion with direct measurement of oxygen uptake and carbon dioxide excretion with gas-exchange online-measurement equipment (Cosmed Quark, Rome, Italy).

  Baseline to week 12

Secondary Outcomes (5)

• Change in Body composition

  Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24

• Changes in bloodbiochemistry from fasting blood samples

  Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24

• Changes in patient-reported Quality of Life

  Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24

• Changes in insulin sensityvity by measure of Oral Glucose Tolerance Test (OGTT)

  Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24

• Change in VO2peak (secondary comparisons)

  baseline-to-week24, week 12-to-week 24

Study Arms (2)

InterWalk

EXPERIMENTAL

The intervention program will prescribe that patients performing 150 min of interval training per week.

Behavioral: InterWalk

Waiting list Control

OTHER

Patients allocated to the waiting-list control group will receive usual care control for the first 12 weeks of the study and will receive the same instructions for download and use of the InterWalk app in the final 12 weeks.

Behavioral: Waiting list control

Interventions

InterWalk BEHAVIORAL

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

InterWalk

Waiting list control BEHAVIORAL

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

Waiting list Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a verified stage I-III CRC diagnosis who has
• All surgical and oncological treatments must be terminated

You may not qualify if:

• Pregnancy
• Ongoing treatment for any known current malignancy
• Performance status \> 1
• Inability to read and understand Danish
• Physically active for more than 150 minutes (moderate intensity) per week thus adhering to the current recommendations

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Hvidovre University Hospital: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Christensen JF, Sundberg A, Osterkamp J, Thorsen-Streit S, Nielsen AB, Olsen CK, Djurhuus SS, Simonsen C, Schauer T, Ellingsgaard H, Osterlind K, Krarup PM, Mosgaard C, Vistisen K, Tolver A, Pedersen BK, Hojman P. Interval Walking Improves Glycemic Control and Body Composition After Cancer Treatment: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3701-3712. doi: 10.1210/jc.2019-00590.

  PMID: 31220283 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Officials

• Jesper F Christensen, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 31, 2015
• Study Start: August 1, 2015
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

DK (2)