Optimizing Physical Function Before Cancer Surgery in Older People at Risk

Study Overview
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Brief Summary
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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
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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: Preoperative physical function in a short-term perspective Postoperative complications and functional decline 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

Official Title
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Optimizing Physical Function Before Surgery: Effects on Complications and Physical Function After Gastrointestinal Cancer Surgery in Older People at Risk- A Randomized Controlled Trial

Conditions
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Colorectal Cancer, Postoperative Complications

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>A high-intensity, home-based, exercise program consisting of inspiratory muscle training (IMT), endurance- and functional strength exercise. The sessions will supervised by a physiotherapist during six occasions and start 2-3 weeks before surgery. IMT will be conducted with an intensity starting from 50 % of maximal capacity, with a self-reported effort of 5-7 on the Borgs CR-10 scale. Endurance and functional strength exercises will be performed at a self-reported effort of 7-8. Interval training, chair stand- and step-up exercises will be key components of the exercise program. Furthermore, the program will include task-specific exercises based on the participants self-expressed needs. On non-supervised days, participants will perform IMT twice a day as well as endurance and strength training, 2-3 days per week with 1-2 days per week of active recovery in the form of moderate intensity walks. This will be monitored with an activity journal and an accelerometer. | Other: Exercise<br>* Preoperative exercise<br>|
| No Intervention: Control group<br>Participants in the control group receive pre- and postoperative care as usual. In addition, they will be encouraged to follow the WHO guidelines of moderate intensity aerobic physical activity for at least 150 min per week. Their activity level will be monitored with an accelerometer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The number of days spent at hospital. Data will be collected from the medical records. Outcome is number of days. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 6 and 12 months post-surgery | 
| Mortality | Mortality data will be collected from medical records. | Baseline (post-surgery), 12, 24, and 36 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Exercise