Clinical trial · Interventional
Walking and Sitting Difficulties After Rectal Cancer Surgery
WASA - Walking and Sitting Difficulties After APE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer Patients | — | UNRESOLVED | — |
| Rectal Cancer, Radiotherapy | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
| Rectal Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control arm with WHO recommendation on physical activity | Procedure | — | UNRESOLVED |
| Targeted leaderled training program | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Training intervention arm
- description
- Targeted supervised training program of specific training of levator, abdominal, quadriceps (all portions), and gluteal muscles as well as endurance training.
- interventionNames
- Procedure: Targeted leaderled training program
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- 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.
- interventionNames
- Procedure: Control arm with WHO recommendation on physical activity
Primary outcomes (1)
- measure
- 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)?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDMahmoudian 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
- BACKGROUNDOnerup 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
- BACKGROUNDOnerup 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
- BACKGROUNDhttps://iris.who.int/bitstream/handle/10665/44399/9789241599979_eng.pdf?seque nce=1 2019 Nov;45(11):2045-2051.
- BACKGROUNDBjorklund 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
- BACKGROUNDAsplund 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