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

Surgery Clinical Trial

Official title:

The Impact of Physical Exercise on Sleep Quality and Duration in Colorectal Cancer Patients During Prehabilitation Period: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270500
• Other study ID #: PA-Sleep
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Montreal General Hospital
• Contact: Sarah Atoui, MSc
• Phone: 514-934-1934
• Email: sarah.atoui[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Albrecht TA, Taylor AG. Physical activity in patients with advanced-stage cancer: a systematic review of the literature. Clin J Oncol Nurs. 2012 Jun 1;16(3):293-300. doi: 10.1188/12.CJON.293-300. Review. — View Citation

Brunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1 — View Citation

Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102. — View Citation

Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3. — View Citation

Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial. J Pain Sympt — View Citation

Cho MH, Dodd MJ, Cooper BA, Miaskowski C. Comparisons of exercise dose and symptom severity between exercisers and nonexercisers in women during and after cancer treatment. J Pain Symptom Manage. 2012 May;43(5):842-54. doi: 10.1016/j.jpainsymman.2011.05.0 — View Citation

Coles T, Bennett AV, Tan X, Battaglini CL, Sanoff HK, Basch E, Jensen RE, Reeve BB. Relationship between sleep and exercise as colorectal cancer survivors transition off treatment. Support Care Cancer. 2018 Aug;26(8):2663-2673. doi: 10.1007/s00520-018-411 — View Citation

Davies NJ, Batehup L, Thomas R. The role of diet and physical activity in breast, colorectal, and prostate cancer survivorship: a review of the literature. Br J Cancer. 2011 Nov 8;105 Suppl 1:S52-73. doi: 10.1038/bjc.2011.423. Review. — View Citation

Lin KY, Shun SC, Lai YH, Liang JT, Tsauo JY. Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. Cancer Nurs. 2014 Mar-Apr;37(2):E21-9. doi: 10.1097/NCC.0b013e3182791097. — View Citation

Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045. — View Citation

Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. Epub 2006 Jul 5. — View Citation

Rabin C, Pinto B, Dunsiger S, Nash J, Trask P. Exercise and relaxation intervention for breast cancer survivors: feasibility, acceptability and effects. Psychooncology. 2009 Mar;18(3):258-66. doi: 10.1002/pon.1341. — View Citation

Romain B, Rohmer O, Schimchowitsch S, Hübner M, Delhorme JB, Brigand C, Rohr S, Guenot D. Influence of preoperative life satisfaction on recovery and outcomes after colorectal cancer surgery - a prospective pilot study. Health Qual Life Outcomes. 2018 Jan — View Citation

Young-McCaughan S, Mays MZ, Arzola SM, Yoder LH, Dramiga SA, Leclerc KM, Caton JR, Sheffler RL, Nowlin MU. Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a s — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insomnia Severity Index (ISI): "change" is being assessed	To report the perceived severity of difficulties falling asleep, difficulties maintaining sleep and early morning awakenings, as well as the degree of dissatisfaction with current sleep, the degree to which sleep difficulties interfere with daytime functioning, the degree to which the deterioration of functioning related to the sleep problem is noticeable by others, and the level of distress or worry caused by the sleep difficulties.; The total score is interpreted as follows: the absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Chronotype: "change" is being assessed	One hears about 'morning' and 'evening' types of people with 5 response categories.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	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)	A reliable and valid generic index of perceived health status for cancer patients and used on the previous study for patients undergoing scheduled colorectal surgery. 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	The World Health Organization Disability Assessment Schedule (WHODAS 2.0): "change" is being assessed	12 items used to measures disability due to health conditions including diseases, illnesses, injuries, mental or emotional problems, and problems with alcohol or drugs.; The sum score for global disability therefore ranges from 0 (no disability) to 48 (complete disability).	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Patient-Generated Subjective Global Assessment (PG-SGA): "change" is being assessed	Validated for oncologic patients, it comprises 4 scored domains: recent weight loss, food intake, symptoms, and activities and functions. PG-SGA Short Form is a patient-reported instrument for the assessment of nutrition status in patients with cancer. The PG-SGA Short Form numerical scoring range from 0 (no problems) to 36 (worst problem).	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	The oxygen peak during cardiopulmonary exercise testing (CPET): "change" is being assessed	CPET has a growing role in major abdominal surgery to guide decision-making by clinicians and to evaluate the consequences of neo-adjuvant therapies and prehabilitation programs.; The term 'peak VO2' is used as a synonym for VO2 max throughout this text. Peak VO2 is considered abnormal when below 85% of the predicted value.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Anaerobic threshold (AT) measured during cardiopulmonary exercise testing (CPET): "change" is being assessed	The VO2 value measured in the first ventilatory threshold (VT1) or anaerobic threshold (AT) is determined by the nonlinear increase of pulmonary ventilation (VE) in relation to VO2. The normal mean AT values expected for adults is around 40% to 65% of peak VO2.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Pulmonary ventilation measured during cardiopulmonary exercise testing (CPET): "change" is being assessed	Pulmonary ventilation (VE): Ventilation increases continuously during progressive effort on CPET and undergoes additional increases influenced by the anaerobic metabolism resulting from the accumulation of lactic acid, well defined as the first and second ventilatory thresholds. Periodic (or oscillatory) ventilation is defined as the resting oscillatory pattern that persists in = 60% of the effort with an amplitude of = 15% as compared to mean resting values.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	CO2 production: "change" is being assessed	CO2 production measured during cardiopulmonary exercise testing (CPET)	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	O2 consumption: "change" is being assessed	O2 consumption measured during cardiopulmonary exercise testing (CPET)	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Respiratory coefficient measured during cardiopulmonary exercise testing (CPET): "change" is being assessed	Respiratory coefficient or respiratory exchange ratio (R): expresses the ratio between CO2 production and O2 consumption (VCO2/VO2). It is currently the best non-invasive indicator of maximal or quasi-maximal exercise intensity. Values above 1.0 can reflect intense exercise, but those = 1.10 are those searched on CPET, and have been accepted as a parameter of exhaustion or quasi-exhaustion.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Muscle strength Handgrip strength will be measured with the Jamar hydraulicdynamometer, in kg: "change" is being assessed	Maximal strength will be recorded, according to standardized procedures. Isokinetic leg strength will be measured with a Biodex on the dominant side.; Loss of muscle strength was defined as < 30kg (men) and < 20 kg (women).	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Height: "change" is being assessed	Height with a ruler on the wall measured in cm	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Other	Weight: "change" is being assessed	Bodyweight will be measured by a digital scale by the Seca mBCA machine in kg	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Primary	Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed	This questionnaire was developed to assess the global subjective sleep disturbances of the previous month. The PSQI is a 19-item self-report measure of broad sleep disturbances over the past month and yields 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction), which are added to create a total score. Each score ranging from 0 to 3 and a total score range of 0-21, a score of 0 indicated no sleep problems and 3 indicated serious sleep problems.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Primary	Sleep quality by an Actigraphy: "change" is being assessed	Sleep quality will be objectively measured using the Actiwatch-2. The Actiwatch-2 (Philips, Respironics) is a small, waterproof, non-intrusive actigraphy device that is worn on the wrist of the non-dominant hand. By calculating orientation and movement, actigraphy records sleep-wake activity and provide an objective measure of sleep quality.	4 weeks before surgery and 4 weeks after the surgery
Secondary	Community Health Activities Model Program for Seniors (CHAMPS) questionnaire: "change" is being assessed	The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. The CHAMPS has been validated as a measure of increasing levels of physical activity in older adults.; 1 METs), low-light (ie, > 1 and =2 METs; eg, playing cards), high-light (ie, >2 and <3 METs; eg, light walking), moderate-to-vigorous physical activity (MVPA, =3 METs), and "total activity" (=2 METs)	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Secondary	Daily activity counts measured by an Actigraphy: "change" is being assessed	The Actiwatch-2 (Philips, Respironics) provide an objective measure of the daily activity counts.	4 weeks before surgery and 4 weeks after the surgery
Secondary	Functional capacity using the six-minute walk test (6MWT): "change" is being assessed	The 6MWT evaluates the ability to maintain a moderate level of physical activity reflecting the activities of daily living. Norms available: The six-minute walk distance in healthy adults has been reported to range from 400m to 700m. A lower score (reflecting less distance covered in 6 minutes) indicates worse function.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Secondary	Hospital Anxiety and Depression Scale (HADS): "change" is being assessed	The HADS contains seven items, each scored from 0 to 3 points for anxiety and depression. It provides summary measures on a scale of 0-21, with scores exceeding 8 suggesting the presence of a mood disorder.	At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.