Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial

Low Anterior Resection Syndrome Clinical Trial

Official title:

Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682157
• Other study ID #: RCT-PAULA-LARS-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2024
• Source: Hadassah Medical Organization
• Contact: Noam Shussman, MD
• Phone: +972 2 6779758
• Email: noams[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients 6-18 months post restorative surgery (either resection with a primary functional anastomosis or after the closure of a temporary ileostomy following curative surgery for rectal cancer) and, if applicable, at least one month post last adjuvant chemotherapy treatment
• LARS score of 21 or greater
• age 18 or older
• able to read and write in Hebrew or English
• able and willing to comply with the study requirements.

Exclusion Criteria:

• Chronic anal incontinence prior to surgery
• inability to perform exercises due to cognitive or physical limitations
• actively engaged in pelvic floor muscle exercises
• pregnancy.

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Intervention

Other:
• Paula Method of muscle exercises
12 weekly sessions of Paula Method of exercise

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LARS score	Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).	12 weeks