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.
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
Preoperative exercise
Karolinska University Hospital Huddinge
Huddinge, Karolinska Institutet, Sweden
Karolinska University Hospital Solna
Stockholm, Sweden
Ersta hospital
Stockholm, Sweden
Stockholm South General Hospital
Stockholm, Sweden
Number of participants with Postoperative Complications 30 days post-surgery
The Clavien-Dindo classification system will be used to describe the occurence of post-operative complications.
Time frame: 30 days post-surgery
Change in maximal walking distance
The 6-minute walk test will be used to assess physical endurance. The test requires subjects to walk as far as possible during 6 minutes. Outcome is metres walked.
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Length of hospital stay
The number of days spent at hospital. Data will be collected from the medical records. Outcome is number of days.
Time frame: Baseline (day of hospital admission), day of hospital discharge (average: 5 days)
Quality of life as assessed by the EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (EORTC QLQ-C30) and the supplemental Elderly Cancer Patients Module will be used to assess quality of life. The scale is comprised of nine subscales: one global health status scale, five functioning scales and three symptom scales. The scales range from 0-100 scores. Higher scores for the global health status scale and functioning scales indicate better outcomes. For the symptom scales, higher scores indicate worse outcomes.
Time frame: Baseline, 6 and 12 months post-surgery
Quality of life as assessed by the EORTC QLQ-ELD14
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for the Elderly Cancer Patients Module (EORTC QLQ-ELD14) will be used to assess quality of life. The scale is comprised of five subscales: mobility, family support, worries about the future, maintaining autonomy and purpose, and burden of illness. The scales range from 0-100 scores. For the family support scale and the autonomy and purpose scale, higher scores indicate better outcomes. For the mobility, worries and burden of illness scales, higher scores indicate worse outcomes.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
Time frame: Baseline, 6 and 12 months post-surgery
Destination of discharge from the hospital
Data on destination of discharge will be collected from the medical journal. The information will be categorized into home, rehabilitation facility or further care (in e.g a geriatric clinic or residential care).
Time frame: Day of hospital discharge (average: 5 days)
Patient-reported symptoms
The Postoperative Recovery Profile. The scale consists of physical symptoms, physical function, psychological and social impact and activity. The results are divided in 5 categories from not recovered at all to fully recovered.
Time frame: 2-3 days post-surgery, day of hospital discharge (average: 5 days), and 6 months post-surgery
Delirium
Confusion Assessment Method consists of 9 item, if you fulfill one of the items 1-4, you are diagnosed with confusion.
Time frame: 2-3 days post-surgery
Change in lower extremity strength
The 30-second chair stand test will be used to measure functional lower extremity strength. Outcome is the number of times the patient comes to a full standing position in 30 seconds.
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Change in maximal inspiratory muscle strength
Micro respiratory pressure meter is measured using the MicroRPM.
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Level of independence in daily living
The ADL-staircase is an hierarchical scale with 10 items including both personal and instrumental activities ranging from inpedendent to dependent.
Time frame: Baseline, 6 and 12 months post-surgery
Physical activity level
Physical Activity Scale for the Elderly includes time spent in sitting, exercise, leisure, household/gardening and work/voluntary activities. It scores from 0 to 400, higher score indicate higher activity level.
Time frame: Baseline, 6 and 12 months post-surgery
Mortality
Mortality data will be collected from medical records.
Time frame: Baseline (post-surgery), 12, 24, and 36 months post-surgery