Clinical trial NCT04270500: The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period
Official title: The Impact of Physical Exercise on Sleep Quality and Duration in Colorectal Cancer Patients During Prehabilitation Period: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colo-rectal Cancer
Surgery
Keywords: Colo-rectal Cancer
Colo-rectal Surgery
Prehabilitation
Sleep quality
Sleep duration
Physical exercise
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled pilot trial of patients with colorectal cancer scheduled for major abdominal surgery. The prehabilitation intervention group will be compared with the usual care for an average of 4 weeks before planned surgery. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior.

The intervention will last for 4 weeks pre- and 8 weeks post-surgery, for a total of 12 weeks. Site visits will occur weekly before surgery and every 4 weeks after surgery. In that period, weekly phone calls will reinforce compliance and provide tips to help patients adhere to the treatment protocol. A dedicated and specially trained research team lead by a physician, a kinesiologist, a nutritionist and a psychologist will perform the measurements and collect the demographic and surgical details of all the patients, recording daily detailed information of clinical outcomes up to 8 weeks after surgery.
Primary purpose: PREVENTION

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?

Detailed description: Participants will be referred by colorectal surgery of the MUHC-Montreal General Hospital; 100 participants will be studied. Inclusion: adult patients aged 18 years and older, of either sex undergoing colorectal cancer surgery. 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: Randomized controlled trial of two parallel arms: prehabilitation program and standard of care (SOC). Informed consent forms will be signed and dated before the conduct of any study-specific procedures. After baseline assessment, participants will be random, by a computer program, allocated to either an intervention or a control group. Duration and follow-up. The intervention will last for 4 weeks pre- and 8 weeks post-surgery, for a total of 12 weeks. Site visits will occur weekly before surgery and every 4 weeks after surgery. In that period, weekly phone calls will reinforce compliance and provide tips to help patients adhere to the treatment protocol. A dedicated and specially trained research team lead by a physician, a kinesiologist, a nutritionist and a psychologist will perform the measurements and collect the demographic and surgical details of all the patients, recording daily detailed information of clinical outcomes up to 8 weeks after surgery.

Interventions: Common to both groups: as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior. The following outcomes will be assessed for all participants, at the baseline and will be repeated after 4 weeks, before and after the surgery: sleep behaviors included sleep quality and duration, assessed subjectively and objectively. Self-reported and objective outcome measurements will be assessed from all participants such as the 6-minute walk distance (6MWD), daily activity counts, exercise tolerance (CPET) and handgrip strength, Insomnia Severity Index (ISI), Chronotype, health-related quality of life assessed by using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS) used to assess emotional distress.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Sleep quality by an Actigraphy: "change" is being assessed
timeFrame: 4 weeks before surgery and 4 weeks after the surgery
Secondary outcomes:
measure: Community Health Activities Model Program for Seniors (CHAMPS) questionnaire: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Daily activity counts measured by an Actigraphy: "change" is being assessed
timeFrame: 4 weeks before surgery and 4 weeks after the surgery
measure: Functional capacity using the six-minute walk test (6MWT): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Hospital Anxiety and Depression Scale (HADS): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other outcomes:
measure: Insomnia Severity Index (ISI): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Chronotype: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Health-related quality of life will be assessed using the Medical Outcomes Study 36-Item: "change" is being assessed Short-Form Health Survey (SF-36)
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: The World Health Organization Disability Assessment Schedule (WHODAS 2.0): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Patient-Generated Subjective Global Assessment (PG-SGA): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: The oxygen peak during cardiopulmonary exercise testing (CPET): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Anaerobic threshold (AT) measured during cardiopulmonary exercise testing (CPET): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Pulmonary ventilation measured during cardiopulmonary exercise testing (CPET): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: CO2 production: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: O2 consumption: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Respiratory coefficient measured during cardiopulmonary exercise testing (CPET): "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Muscle strength Handgrip strength will be measured with the Jamar hydraulicdynamometer, in kg: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Height: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
measure: Weight: "change" is being assessed
timeFrame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sender Liberman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
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