Recruiting

Physical Exercise

Sponsor:

Montreal General Hospital

Code:

NCT04270500

Conditions

Colo-rectal Cancer

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation program

Study Details

Brief 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

Study ID

NCT04270500

Start date

Sep 15, 2020

Status verified date

Apr, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult persons scheduled for resection of malignant colorectal lesions will be included

Exclusion Criteria:

  • A compromised health status (American Society of Anesthesiologists \[ASA\] class 4-5) or comorbid medical conditions interfering with the ability to perform an exercise.
  • Patients are unable to understand the information given, insufficient understanding of English or French language to provide informed consent or who are considered unable to perform study-specific procedures.
  • Patients that diagnosis of a sleep disorder other than insomnia (e.g., sleep-disordered breathing) or received psychotherapy specifically for insomnia, as well as a night-shift worker in the past 3 months or the next 18 months will be excluded

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

no intervention: Standard of care (SOC)

Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution.

Interventions

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.

Primary outcome measure

  • Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed [ Time Frame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery. ]
  • Sleep quality by an Actigraphy: "change" is being assessed [ Time Frame: 4 weeks before surgery and 4 weeks after the surgery ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Principal Investigator:

Sender Liberman, MD

More Information

Sponsor

Montreal General Hospital

Last update posted

Apr 7, 2022

Last verified

Apr, 2022

Keywords

  • Colo-rectal Cancer
  • Colo-rectal Surgery
  • Prehabilitation
  • Sleep quality
  • Sleep duration
  • Physical exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal General Hospital on 2022-04-07.