Paula Method of Exercises in Patients With LARS Syndrome

NCT ID: NCT05016583

Last Updated: 2022-10-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2022-07-04

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

Detailed Description

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Conditions

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Low Anterior Resection Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paula Method

Group Type EXPERIMENTAL

Paula Method

Intervention Type OTHER

12 weeks of Paula Method of Exercises

Interventions

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Paula Method

12 weeks of Paula Method of Exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Nocera F, Angehrn F, von Flue M, Steinemann DC. Optimising functional outcomes in rectal cancer surgery. Langenbecks Arch Surg. 2021 Mar;406(2):233-250. doi: 10.1007/s00423-020-01937-5. Epub 2020 Jul 26.

Reference Type BACKGROUND
PMID: 32712705 (View on PubMed)

Nguyen TH, Chokshi RV. Low Anterior Resection Syndrome. Curr Gastroenterol Rep. 2020 Aug 4;22(10):48. doi: 10.1007/s11894-020-00785-z.

Reference Type BACKGROUND
PMID: 32749603 (View on PubMed)

Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29.

Reference Type BACKGROUND
PMID: 33249611 (View on PubMed)

Other Identifiers

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PAULA-LARS-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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