Optimizing Physical Function Before Cancer Surgery in Older People at Risk

NCT04878185 | Unknown

• 1 other identifier: EPN2015/1179-31
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Postoperative Complications

Keywords

Preoperative Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Length of hospital stay

  Baseline (day of hospital admission), day of hospital discharge (average: 5 days)

• Quality of life as assessed by the EORTC QLQ-C30

  Baseline, 6 and 12 months post-surgery

• Quality of life as assessed by the EORTC QLQ-ELD14

  Baseline, 6 and 12 months post-surgery

• Destination of discharge from the hospital

  Day of hospital discharge (average: 5 days)

• Patient-reported symptoms

  2-3 days post-surgery, day of hospital discharge (average: 5 days), and 6 months post-surgery

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Exercise OTHER

Preoperative exercise

Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (4)

Karolinska University Hospital Huddinge

Huddinge, Karolinska Institutet, 14183, Sweden

Location

Karolinska University Hospital Solna

Stockholm, 171 76, Sweden

Location

Ersta hospital

Stockholm, Sweden

Location

Stockholm South General Hospital

Stockholm, Sweden

Location

Related Publications (7)

• 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.

  PMID: 19516148 BACKGROUND

• 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.

  PMID: 12011598 BACKGROUND

• 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.

  PMID: 30201418 BACKGROUND

• 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.

  PMID: 19204579 BACKGROUND

• 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.

  PMID: 26436600 BACKGROUND

• Danielsson J, Engstrom Sid J, Andersson M, Nygren-Bonnier M, Egenvall M, Hagstromer M, Vossen LE, Dohrn IM, Rydwik E. Optimizing Physical Fitness Before Colorectal Cancer Surgery (CANOPTIPHYS): The Effect of Preoperative Exercise on Pre- and Postoperative Physical Fitness in Older people - A Randomized Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251346417. doi: 10.1177/21501319251346417. Epub 2025 Jun 17.

  PMID: 40525350 DERIVED

• Andersson M, Egenvall M, Danielsson J, Thorell A, Sturesson C, Soop M, Nygren-Bonnier M, Rydwik E. CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in older people at risk-a multicentre, randomised, parallel-group study. Trials. 2023 Jan 19;24(1):41. doi: 10.1186/s13063-022-07026-w.

  PMID: 36658653 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisabeth Rydwik, Assoc prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: May 7, 2021
• Study Start: May 10, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion 2024
• 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.

Locations

SE (4)