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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Other: Paula Method of muscle exercises

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noam Shussman, MD; Phone Number: +972 2 6779758; Email: noams@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Organization
    • Contact: Hadas Lemberg, PhD; Phone Number: 00 972 2 6777572; Email: lhadas@hadassah.org.il
  • Petach Tikva, Israel
    • Not yet recruiting
    • Rabin Medical Center
    • Contact: Ian White, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paula Method; 12 weeks of the Paula Method of muscle exercises with standard care	Other: Paula Method of muscle exercises; 12 weekly sessions of Paula Method of exercise
No Intervention: Standard Care; standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Noam Shussman, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rectal Cancer; Anal incontinence; Paula Method; Sphincter sparing rectal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: RCT-PAULA-LARS-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No