Walking and Sitting Difficulties After Rectal Cancer Surgery

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

Interventions

PROCEDURE

Targeted leaderled training program

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

PROCEDURE

Control arm with WHO recommendation on physical activity

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

Sponsors & Collaborators

• Göteborg University

  collaborator OTHER

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2029-10-01

Completion

2031-04-01

Countries

• Sweden

Study Locations