Paula Method of Exercises in Patients With LARS Syndrome

October 9, 2022 updated by: Hadassah Medical Organization

Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study

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 feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over age 18
  • LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection
  • Able to read, understand and communicate in Hebrew

Exclusion Criteria:

  • Pregnancy
  • Actively undergoing Chemotherapy or Radiation
  • Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome)
  • Concurrent performance of other exercise methods
  • Unable or unwilling to perform the Paula exercises

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paula Method
Other: Paula Method
12 weeks of Paula Method of Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in LARS (Low Anterior Resection Syndrome) Score
Time Frame: 12 weeks

Decrease of in the LARS Score from baseline measurement to the end of the study measurement.

The scale is based on a score of 0-42 . A score of 0-20 indicates the absence of LARS, 21-29- Minor LARS, and 30-42- Major LARS.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 28, 2021

Primary Completion (ACTUAL)

July 4, 2022

Study Completion (ACTUAL)

July 4, 2022

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (ACTUAL)

August 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAULA-LARS-HMO-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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