RecruitingNot ApplicableNCT05682157

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

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


Sponsor

Hadassah Medical Organization

Enrollment

62 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specific exercise program called the Paula Method can help patients who experience bowel problems after rectal cancer surgery — a condition known as Low Anterior Resection Syndrome (LARS), which can cause urgency, frequency, and difficulty controlling bowel movements. **You may be eligible if...** - You are 18 or older - You had rectal cancer surgery (with bowel reconnection or after closure of a temporary stoma) 6–18 months ago - You have significant bowel symptoms (a LARS score of 21 or higher) - You can read and write in Hebrew or English - If you received chemotherapy, at least one month has passed since your last treatment **You may NOT be eligible if...** - You had bowel control problems before your surgery - You are unable to exercise due to physical or cognitive limitations - You are already doing pelvic floor muscle exercises - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPaula Method of muscle exercises

12 weekly sessions of Paula Method of exercise


Locations(2)

Hadassah Medical Organization

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

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NCT05682157


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