360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

December 21, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

Comparison of the Effectiveness of Kegel Exercises and 360-degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

The aim of this study is to investigate the effect of transferring the healthy intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the patient to the pelvic cavity on incontinence problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

66 people with a score of 3 or higher on the Incontinence Severity Index will be included in the study. All participants will complete the King Health Questionnaire and Incontinence Quality of Life Questionnaires. The control group will consist of 33 people and will apply only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires will be asked to be filled again. The variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Study Type

Interventional

Enrollment (Actual)

66

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

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey
        • Üsküdar Unıversıty

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Getting a score of 3 and above in the incontinence severity index.
  • Be in the age range of 12-65 years.
  • No neurological problems.

Exclusion Criteria:

• Having a history of surgery or childbirth in the last 3 months.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: kegel group
Participants will only practice kegel exercises.
Other: kegel exercises
Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.
Experimental: diaphragm group
In addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.
Other: kegel exercises
Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.
Other: 360 degree expanded diaphragmatic breathing training
360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incontinence severity index (ISI)
Time Frame: 10 weeks
It was developed in epidemiological and clinical studies to identify women with urinary incontinence of varying severity. The questionnaire score is obtained by multiplying the value given to the frequency of urinary incontinence by the value given to the amount of urinary incontinence. The result obtained; classified as mild, moderate, severe, very severe.
10 weeks
Understanding King's Health Questionnaire (KHQ)
Time Frame: 10 weeks
The King's Health questionnaire is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. It includes 7 sub-headings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). For other areas, scores range from 0 (best) to -100 (worst).
10 weeks
Incontinence Quality of Life Questionnaire (I-QOL)
Time Frame: 10 weeks
In the Incontinence Quality of Life Scale (I-QOL), which consists of 22 items, all items are evaluated on a five-category Likert-type scale (1= a lot, 2= a lot, 3= moderately, 4= a little, 5= not at all). The scores of the questionnaire and its subscales are obtained by adding the scores of each item and dividing this total by the number of items. For easier explanation of the scores, the calculated total score is converted to a scale value from 0 (lowest quality of life) to 100 (highest quality of life). High scores indicate better quality of life than low scores.
10 weeks

Collaborators and Investigators

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

Sponsor

Uskudar University

Investigators

  • Study Chair: Elif AKAR, Uskudar University

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)

September 1, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar64

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

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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