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Walking and Sitting Difficulties After Rectal Cancer Surgery

ConditionsRectal Cancer PatientsRectal Cancer SurgeryRectal Cancer, RadiotherapyRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted leaderled training program

    Procedure/Surgery

    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

    Procedure/Surgery

    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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Training intervention armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

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".

Time frame
12 months

Secondary outcomes

1

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

Patient reported sitting and walking difficulties by validated question in questionnaire at 6 and 24 months with items from "no difficulties" to "severe difficulties"

Time frame
6 and 24 months
2

Objective tests

Balance test as time in seconds standing on one leg, measured by a research nurse

Time frame
baseline, 6, 12 and 24 months
3

Pain

Pain, as reported by patient using validated instrument, Body Pain Inventory - Short Form (BPI-SF) included in questionnaire. Scored 0 (no pain) -10 (worst) on up to seven items.

Time frame
6, 12 and 24 months
4

Comprehensive Complication Index (CCI)

Postoperative complications classified by CCI. Each complications is graded by Clavien-Dindo system and added into a score from 0 (no complications) to 100 (death).

Time frame
Within 30 and 90 days of abdominoperineal excision surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Göteborg University

Sponsor institution

Göteborg University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: