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

NCT04270500 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-07

No results posted yet for this study

Summary

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?

Conditions

  • Colo-rectal Cancer
  • Surgery

Interventions

BEHAVIORAL

Prehabilitation program

The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.

Sponsors & Collaborators

  • Montreal General Hospital

    lead OTHER

Principal Investigators

  • Sender Liberman, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Franco Carli, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270500 on ClinicalTrials.gov