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Optimizing Physical Function Before Cancer Surgery in Older People at Risk (CanOptiPhys)

Primary Purpose

Colorectal Cancer, Postoperative Complications

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Preoperative Exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital Huddinge
  • Karolinska University Hospital Solna
  • Ersta hospital
  • Stockholm South General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Length of hospital stay
The number of days spent at hospital. Data will be collected from the medical records. Outcome is number of 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.
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.
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).
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.
Delirium
Confusion Assessment Method consists of 9 item, if you fulfill one of the items 1-4, you are diagnosed with confusion.
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.
Change in maximal inspiratory muscle strength
Micro respiratory pressure meter is measured using the MicroRPM.
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.
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.
Mortality
Mortality data will be collected from medical records.

Full Information

First Posted
April 6, 2021
Last Updated
October 18, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04878185
Brief Title
Optimizing Physical Function Before Cancer Surgery in Older People at Risk
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Postoperative Complications
Keywords
Preoperative Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Preoperative exercise
Primary Outcome Measure Information:
Title
Number of participants with Postoperative Complications 30 days post-surgery
Description
The Clavien-Dindo classification system will be used to describe the occurence of post-operative complications.
Time Frame
30 days post-surgery
Title
Change in maximal walking distance
Description
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)
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
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)
Title
Quality of life as assessed by the EORTC QLQ-C30
Description
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
Title
Quality of life as assessed by the EORTC QLQ-ELD14
Description
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.
Time Frame
Baseline, 6 and 12 months post-surgery
Title
Destination of discharge from the hospital
Description
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)
Title
Patient-reported symptoms
Description
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
Title
Delirium
Description
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
Title
Change in lower extremity strength
Description
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)
Title
Change in maximal inspiratory muscle strength
Description
Micro respiratory pressure meter is measured using the MicroRPM.
Time Frame
Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Title
Level of independence in daily living
Description
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
Title
Physical activity level
Description
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
Title
Mortality
Description
Mortality data will be collected from medical records.
Time Frame
Baseline (post-surgery), 12, 24, and 36 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Rydwik, Assoc prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital Huddinge
City
Huddinge
State/Province
Karolinska Institutet
ZIP/Postal Code
14183
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Ersta hospital
City
Stockholm
Country
Sweden
Facility Name
Stockholm South General Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is not publicly available, but available upon request.
IPD Sharing Time Frame
After study completion 2024
IPD Sharing Access Criteria
Requests for access to the data can be put to our Research Data Office (rdo@ki.se) at Karolinska Institutet, and will be handled according to the relevant legislation. This will require a data processing agreement or similar with the recipient of the data.
Citations:
PubMed Identifier
19516148
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.
Results Reference
background
PubMed Identifier
12011598
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.
Results Reference
background
PubMed Identifier
30201418
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.
Results Reference
background
PubMed Identifier
19204579
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.
Results Reference
background
PubMed Identifier
26436600
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.
Results Reference
background

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Optimizing Physical Function Before Cancer Surgery in Older People at Risk

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