NCT04270500

The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period

Status unknown NA Last updated 7 April 2022

What this trial tests

NA trial testing Prehabilitation program in Colo-rectal Cancer in 100 participants. Status unknown.

Timeline

15 September 2020

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	Montreal General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	15 September 2020
Primary completion	30 September 2022
Estimated completion	31 December 2022
Sites	1 location across Canada

Drugs / interventions tested

• Prehabilitation program

Conditions studied

• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• Surgery — all drugs for Surgery →

Sponsor

Montreal General Hospital

Who can join

18 and older, any sex, with Colo-rectal Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT.

Secondary objective: to determine whether the levels of anxiety and depression affect these relationships.

Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression.

The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice.

Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.