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Clinical Trials in Sweden / NCT07035600
Starting soon Not applicable

Walking and Sitting Difficulties After Rectal Cancer Surgery

NCT07035600 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2025-06-25

Condition(s) studied

Rectal Cancer PatientsRectal Cancer SurgeryRectal Cancer, RadiotherapyRectal Cancer

Investigational drug(s) / intervention(s)

Targeted leaderled training programControl arm with WHO recommendation on physical activity

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

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

More Sahlgrenska University Hospital trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035600 on ClinicalTrials.gov ↗ ← All trials in Sweden