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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Anterior Resection Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paula Method

12 weeks of the Paula Method of muscle exercises with standard care

Group Type EXPERIMENTAL

Paula Method of muscle exercises

Intervention Type OTHER

12 weekly sessions of Paula Method of exercise

Standard Care

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paula Method of muscle exercises

12 weekly sessions of Paula Method of exercise

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No