Walking and Sitting Difficulties After Rectal Cancer Surgery

NCT07035600 | Not Yet Recruiting

• 1 other identifier: 2024-08611-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic. WASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part. The patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity. The idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.

Conditions

Rectal Cancer Patients; Rectal Cancer Surgery; Rectal Cancer, Radiotherapy; Rectal Cancer

Keywords

Rectal cancer; Rectal cancer complications

Outcome Measures

Primary Outcomes (1)

• Can a specific physical online training program decrease sitting and walking difficulties 12 months after abdominoperineal excision for rectal cancer compared with standard care (self-administered aerobic training according to WHO recommendations only)?

  Patient reported sitting and walking difficulties by validated questions in questionnaire with items from "no difficulties" to "severe difficulties".

  12 months

Secondary Outcomes (26)

• Self-reported problems with sitting and/or walking and physical activity

  6 and 24 months

• Objective tests

  baseline, 6, 12 and 24 months

• Pain

  6, 12 and 24 months

• Comprehensive Complication Index (CCI)

  Within 30 and 90 days of abdominoperineal excision surgery

• Re-admissions

  Within 12 and 24 months of abdominoperineal excision surgery

Study Arms (2)

Training intervention arm

EXPERIMENTAL

Targeted supervised training program of specific training of levator, abdominal, quadriceps (all portions), and gluteal muscles as well as endurance training.

Procedure: Targeted leaderled training program

Control arm

ACTIVE COMPARATOR

Information of training in accordance with WHO recommendations of 30 min aerobic physical activity five times per week (150 min per week) plus strength sessions twice weekly.

Procedure: Control arm with WHO recommendation on physical activity

Interventions

Targeted leaderled training program PROCEDURE

Training program: After inclusion and consent the patients are instructed through an online group training program consisting of specific training of levator, abdominal, quadriceps (all portions), and gluteal muscles as well as endurance training. They are given information about WHO recommendations about physical activity. The patients are asked to sign up for two specific training occasions per week where no group will be larger than 10 patients. Group based exercise sessions consist of 45-minute supervised online zoom exercise sessions. Apart from the supervised sessions patients are encouraged to perform one functional training session, unsupervised, as well as follow the WHO recommendation for aerobic exercise

Training intervention arm

Control arm with WHO recommendation on physical activity PROCEDURE

Training will be in accordance with WHO recommendations of 30 min aerobic physical activity five times per week (150 min per week) plus strength sessions twice weekly. The patients will be individually adviced on how to perform the training at inclusion in the trial. This is considered standard care and will not include any on-line supervision, but will include a coaching/reminder by a phone call from a research nurse/short message service (by choice of the patient) at regular intervals before and after surgery

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rectal cancer to be treated with/without neoadjuvant (chemo)radiation and abdominoperineal excision with or without mesh (APE/ELAPE) Informed consent Able to read and understand Swedish or Danish

You may not qualify if:

• Patients with rectal cancer to be operated by extended abdominoperineal excision (ELAPE) requiring musculocutaneous or muscular flaps to be operated by Hartmann's procedure to be operated by anterior resection (low or high) participation in other randomized trials in conflict with the protocol and endpoints of the WASA trial Not understanding Swedish or Danish Patients reporting habit of physical activity exceeding the WHO-recommendations (150 min + two strength sessions) at baseline.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Department of Surgery, SSORG - Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, 416 85 Gothenburg, Sweden.

Gothenburg, 416 85, Sweden

Location

Related Publications (6)

• Mahmoudian A, Lohmander LS, Dahlberg LE, Kiadaliri A. Digital Self-management, Analgesic Use, and Patient-Reported Outcomes in Knee or Hip Osteoarthritis. Arch Phys Med Rehabil. 2024 Oct;105(10):1821-1828. doi: 10.1016/j.apmr.2024.05.033. Epub 2024 Jun 10.

  PMID: 38866226 BACKGROUND

• Onerup A, Andersson J, Angenete E, Bock D, Borjesson M, Ehrencrona C, Fagevik Olsen M, Larsson PA, de la Croix H, Wedin A, Haglind E. Effect of Short-term Homebased Pre- and Postoperative Exercise on Recovery After Colorectal Cancer Surgery (PHYSSURG-C): A Randomized Clinical Trial. Ann Surg. 2022 Mar 1;275(3):448-455. doi: 10.1097/SLA.0000000000004901.

  PMID: 33843798 BACKGROUND

• Onerup A, Angenete E, Bonfre P, Borjesson M, Haglind E, Wessman C, Nilsson H. Self-assessed preoperative level of habitual physical activity predicted postoperative complications after colorectal cancer surgery: A prospective observational cohort study. Eur J Surg Oncol. 2019 Nov;45(11):2045-2051. doi: 10.1016/j.ejso.2019.06.019. Epub 2019 Jun 12.

  PMID: 31217078 BACKGROUND

• https://iris.who.int/bitstream/handle/10665/44399/9789241599979_eng.pdf?seque nce=1 2019 Nov;45(11):2045-2051.

  BACKGROUND

• Bjorklund Sand L, Larsson C, Gronkvist R, Haglind E, Angenete E. Persistent Sitting and Walking Difficulties After Abdominoperineal Excision and Anterior Resection: Results From the Quality of Life in Rectal Cancer Study. Dis Colon Rectum. 2025 Jun 1;68(6):704-712. doi: 10.1097/DCR.0000000000003710. Epub 2025 Mar 14.

  PMID: 40085057 BACKGROUND

• Asplund D, Prytz M, Bock D, Haglind E, Angenete E. Persistent perineal morbidity is common following abdominoperineal excision for rectal cancer. Int J Colorectal Dis. 2015 Nov;30(11):1563-70. doi: 10.1007/s00384-015-2328-1. Epub 2015 Aug 6.

  PMID: 26245948 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Charlotta E Larsson, MD, PhD

  Department of Surgery, SSORG - Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden and Region Västra Götaland, Sahlgrenska University Hospital Östra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotta E Larsson, MD, PhD

CONTACT

+ 46706067980; charlotta.e.larsson@vgregion.se

Lina Björklund Sand, MD

CONTACT

lina.bjorklund.sand@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Randomized, interventional, controlled mtrial

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)