Optimizing Physical Function Before Cancer Surgery in Older People at Risk

Colorectal Cancer Clinical Trial

— CanOptiPhys  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04878185
• Other study ID #: EPN2015/1179-31
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Postoperative Complications

Intervention

Other:
• Exercise
Preoperative exercise

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Huddinge	Huddinge	Karolinska Institutet
Sweden	Ersta hospital	Stockholm
Sweden	Karolinska University Hospital Solna	Stockholm
Sweden	Stockholm South General Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Mortality	Mortality data will be collected from medical records.	Baseline (post-surgery), 12, 24, and 36 months post-surgery