Clinical trial NCT04878185: Optimizing Physical Function Before Cancer Surgery in Older People at Risk
Official title: Optimizing Physical Function Before Surgery: Effects on Complications and Physical Function After Gastrointestinal Cancer Surgery in Older People at Risk- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Postoperative Complications
Keywords: Preoperative Exercise
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. The hypothesis is that older patients with low preoperative physical capacity will benefit from preoperative exercise in terms of lower risk for postoperative complications and improved recovery after surgery.

Detailed description: Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to attenuate postoperative decline and possibly decrease the risk of postoperative complications.

A previous observational study showed that better preoperative physical performance in measures of walking distance, leg strength, inspiratory muscle strength and maximal gait speed reduced the risk of severe postoperative complications for older patients undergoing abdominal cancer surgery. Furthermore, gait speed has been suggested to add information to current preoperative risk screening, where a cut of value of a maximal gait speed below 2 meters/second indicates a higher risk for postoperative complications.

This planned trial will be conducted in cooperation with the Karolinska University Hospital, Ersta Hospital, The Stockholm South General Hospital and several primary care units in Stockholm. To target older patients at risk, patients aged 65 and older with a maximal gait speed under 2 meters/second will be included. Participants will be randomized to either intervention- or control group and trained physiotherapists or nurses from the hospitals, will conduct the assessments. All baseline measures will be collected before randomization.

The implementation of standardized cancer care pathways in Sweden has led to reduced time between diagnosis to curative treatment. For colorectal surgery, the time from decision to treatment is set to two weeks. Therefore, an exercise program aimed to enhance physical function prior to surgery require a high intensity and high frequency approach. The exercise program will be home-based and consist of inspiratory muscle training, endurance- and strength exercise under the supervision of trained physiotherapists from primary care units. To assess feasibility of the planned intervention, a pilot study was conducted. The results showed high compliance and acceptability among the participants which provides a starting point for this larger study designed to explore the effects of preoperative exercise on:

1. Preoperative physical function in a short-term perspective
2. Postoperative complications and functional decline
3. Length of in-hospital stay, mortality, health-related quality of life, physical activity level and independency in activities in daily living in a long-term perspective

Eligibility criteria: Inclusion Criteria:

* Scheduled surgery due to colorectal cancer or liver metastases from colorectal cancer
* Age ≥65
* A maximal walking speed below 2 meters per second
* Understands and speaks the Swedish language

Exclusion Criteria:

* Planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or flap surgery
* Health conditions that prevent participation in assessment or exercise. Such conditions include, but are not limited to, unstable heart disease, severe systematic illness or orthopaedic conditions that may prohibit exercise.
* The need for surgery within 2 weeks
* Permanent wheelchair user
* Residence outside of Stockholm County

Primary outcomes:
measure: Number of participants with Postoperative Complications 30 days post-surgery
timeFrame: 30 days post-surgery
measure: Change in maximal walking distance
timeFrame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Baseline (day of hospital admission), day of hospital discharge (average: 5 days)
measure: Quality of life as assessed by the EORTC QLQ-C30
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Quality of life as assessed by the EORTC QLQ-ELD14
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Destination of discharge from the hospital
timeFrame: Day of hospital discharge (average: 5 days)
measure: Patient-reported symptoms
timeFrame: 2-3 days post-surgery, day of hospital discharge (average: 5 days), and 6 months post-surgery
measure: Delirium
timeFrame: 2-3 days post-surgery
measure: Change in lower extremity strength
timeFrame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
measure: Change in maximal inspiratory muscle strength
timeFrame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
measure: Level of independence in daily living
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Physical activity level
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Mortality
timeFrame: Baseline (post-surgery), 12, 24, and 36 months post-surgery
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital Huddinge
state: Karolinska Institutet
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Ersta hospital
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
Study officials:
affiliation: Karolinska Institutet
name: Elisabeth Rydwik, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
citation: Topp R, Ditmyer M, King K, Doherty K, Hornyak J 3rd. The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues. 2002 May;13(2):263-76. doi: 10.1097/00044067-200205000-00011.
citation: Karlsson E, Egenvall M, Farahnak P, Bergenmar M, Nygren-Bonnier M, Franzen E, Rydwik E. Better preoperative physical performance reduces the odds of complication severity and discharge to care facility after abdominal cancer resection in people over the age of 70 - A prospective cohort study. Eur J Surg Oncol. 2018 Nov;44(11):1760-1767. doi: 10.1016/j.ejso.2018.08.011. Epub 2018 Aug 29.
citation: American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
citation: Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.