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Yoga and Pilates Based Respiratory Training Effect for Individuals With Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga-Based Respiration Training
Pilates-Based Respiration Training
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, yoga, pilates, respiratory training

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Having the diagnosis of stress or mixed urinary incontinence. Being volunteer to participate in the study. Being scheduled for surgical waitlist or outpatient treatment program. Having no obstacles for the planned assessments. Exclusion Criteria: Having received treatment for urinary incontinence in the last 3 months. Using medication specifically for urinary incontinence. Using medication for vaginal or urinary tract infections. Pregnancy. Being within the first 3 years postpartum. Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment. History of surgery that may impede the exercise planned within the scope of the study.

Sites / Locations

  • Basaksehir Cam ve Sakura City HospitalRecruiting
  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yoga-based Respiration Group

Pilates-based Respiration Group

Arm Description

This group will be given yoga-based breathing exercises

This group will be given pilates-based breathing exercises

Outcomes

Primary Outcome Measures

International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is used to measure the severity of incontinence. This form includes questions about the frequency and amount of urinary incontinence, its effect on daily life and the causes of urinary incontinence, and an evaluation is made for the last 4 weeks. It is calculated by summing the scores of the 3 dimensions in the test, and a result in the range of 0-21 points is obtained.
24-Hour Pad Test
24-hour pad test The 24-Hour Pad Test is an objective evaluation method used to determine the severity of urinary incontinence. Patients are asked to start the test with an empty bladder. It is requested that the used pad should be changed every 4-6 hours and kept in a locked bag until it is taken to the hospital. Patients use the same type of pad throughout the test and are asked to bring an unused pad of the same type when coming to the hospital. The amount of urinary incontinence is calculated by subtracting the weight of the clean pad from the weight of the pads accumulated within 24 hours. It is classified as 4-20 g mild, 21-74 g moderate, >75 g severe urinary incontinence.
PFM Function- MyoPlusPro EMG Device
Pelvic floor muscle function will be evaluated with electromyographic measurement (EMG). Before the test, participants will be asked to empty their bladders and will be taught to contract and relax the isolated pelvic floor muscle. Surface active electrodes will be placed to the right and left of the perineal body, and they will be asked to make 5 maximal contractions and 5 relaxations, and the obtained values will be recorded in μV.
Incontinence Quality of Life Questionnaire (I-QOL)
Incontinence Quality of Life Questionnaire (I-QOL) includes questions that examine limitation of behavior, psychosocial influence and social isolation. Questions are scored between 1 and 5, and high scores indicate good quality of life.
Incontinence Impact Questionnaire Short Form (IIQ-7)
The Incontinence Impact Questionnaire (IIQ-7) is used to measure the impact of urinary incontinence on individuals' daily and social lives and participation. The survey contains 7 questions, each question is scored between 1 and 4. High scores indicate negative impact.

Secondary Outcome Measures

Core Muscle Endurance Assessment
The endurance of the core muscles will be evaluated with the McGill Core Endurance Test Battery. The test has 4 stages; Trunk Flexor Endurance Test Lateral Flexor Endurance Test Trunk Extensor Endurance Test
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
Maximum inspiratory pressure (MIB) and maximum expiratory pressure (MEP) measurements will be made to assess respiratory function. During the MIB measurement, the participant is asked to make a maximal expiration and maximally inhale at the end of the expiration, and during the MEP measurement, to make a maximal inspiration and then a maximal expiration. Each measurement is repeated 3 times and the best value is recorded.

Full Information

First Posted
September 19, 2023
Last Updated
September 28, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT06054724
Brief Title
Yoga and Pilates Based Respiratory Training Effect for Individuals With Urinary Incontinence
Official Title
Comparison of Yoga-Based and Pilates-Based Respiratory Training Effect for Individuals With Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence.
Detailed Description
In the literature, it has been stated that the pelvic floor alone does not play a singular role in maintaining continence, but rather forms a functional unit with the diaphragm, abdominal, and spinal muscles. Since the inability of any of these structures to perform their function properly negatively affects the function of the others, normalization and optimal functioning of the pelvic floor-thoracic diaphragm relationship are crucial in individuals with urinary incontinence. This study aims to investigate the effectiveness of yoga and Pilates approaches, considering breath as a fundamental building block, through respiration-based training programs in women with urinary incontinence. The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Yoga-based Respiration Group (Group 1) and the Pilates-based Respiration Group (Group 2), using a computer-assisted randomization program. After the groups are assigned, the initial three sessions for both groups will be conducted face-to-face under the guidance of a physiotherapist to ensure the correct execution of the exercises. The exercise program for both groups will consist of approximately 20-minute sessions, with two sessions per day, five days a week, for a total of six weeks. On the days when face-to-face sessions are held, one session will be conducted in-person, while the other session will be performed at home. During the 3rd and 5th weeks, the exercises will be progressively intensified for both groups to ensure progression, and patients will be called for face-to-face sessions. At the end of the six weeks, patients will undergo face-to-face evaluations once again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, yoga, pilates, respiratory training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga-based Respiration Group
Arm Type
Experimental
Arm Description
This group will be given yoga-based breathing exercises
Arm Title
Pilates-based Respiration Group
Arm Type
Experimental
Arm Description
This group will be given pilates-based breathing exercises
Intervention Type
Other
Intervention Name(s)
Yoga-Based Respiration Training
Intervention Description
The selected asanas, believed to be beneficial for urinary incontinence, will be practiced with a focus on breath. After the assessment session, participants will engage in three days of face-to-face yoga sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.
Intervention Type
Other
Intervention Name(s)
Pilates-Based Respiration Training
Intervention Description
Before starting the 6-week practice protocol, participants will be taught the transversus abdominis muscle activation and centering, pilates-specific lateral costal breathing and other key elements of pilates. Pilates exercises chosen as beneficial for urinary incontinence will be performed with a focus on breath. After the assessment session, participants will engage in three days of face-to-face pilates sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Description
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is used to measure the severity of incontinence. This form includes questions about the frequency and amount of urinary incontinence, its effect on daily life and the causes of urinary incontinence, and an evaluation is made for the last 4 weeks. It is calculated by summing the scores of the 3 dimensions in the test, and a result in the range of 0-21 points is obtained.
Time Frame
baseline and post-intervention (7th week)
Title
24-Hour Pad Test
Description
24-hour pad test The 24-Hour Pad Test is an objective evaluation method used to determine the severity of urinary incontinence. Patients are asked to start the test with an empty bladder. It is requested that the used pad should be changed every 4-6 hours and kept in a locked bag until it is taken to the hospital. Patients use the same type of pad throughout the test and are asked to bring an unused pad of the same type when coming to the hospital. The amount of urinary incontinence is calculated by subtracting the weight of the clean pad from the weight of the pads accumulated within 24 hours. It is classified as 4-20 g mild, 21-74 g moderate, >75 g severe urinary incontinence.
Time Frame
baseline and post-intervention (7th week)
Title
PFM Function- MyoPlusPro EMG Device
Description
Pelvic floor muscle function will be evaluated with electromyographic measurement (EMG). Before the test, participants will be asked to empty their bladders and will be taught to contract and relax the isolated pelvic floor muscle. Surface active electrodes will be placed to the right and left of the perineal body, and they will be asked to make 5 maximal contractions and 5 relaxations, and the obtained values will be recorded in μV.
Time Frame
baseline and post-intervention (7th week)
Title
Incontinence Quality of Life Questionnaire (I-QOL)
Description
Incontinence Quality of Life Questionnaire (I-QOL) includes questions that examine limitation of behavior, psychosocial influence and social isolation. Questions are scored between 1 and 5, and high scores indicate good quality of life.
Time Frame
baseline and post-intervention (7th week)
Title
Incontinence Impact Questionnaire Short Form (IIQ-7)
Description
The Incontinence Impact Questionnaire (IIQ-7) is used to measure the impact of urinary incontinence on individuals' daily and social lives and participation. The survey contains 7 questions, each question is scored between 1 and 4. High scores indicate negative impact.
Time Frame
baseline and post-intervention (7th week)
Secondary Outcome Measure Information:
Title
Core Muscle Endurance Assessment
Description
The endurance of the core muscles will be evaluated with the McGill Core Endurance Test Battery. The test has 4 stages; Trunk Flexor Endurance Test Lateral Flexor Endurance Test Trunk Extensor Endurance Test
Time Frame
baseline and post-intervention (7th week)
Title
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
Description
Maximum inspiratory pressure (MIB) and maximum expiratory pressure (MEP) measurements will be made to assess respiratory function. During the MIB measurement, the participant is asked to make a maximal expiration and maximally inhale at the end of the expiration, and during the MEP measurement, to make a maximal inspiration and then a maximal expiration. Each measurement is repeated 3 times and the best value is recorded.
Time Frame
baseline and post-intervention (7th week)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having the diagnosis of stress or mixed urinary incontinence. Being volunteer to participate in the study. Being scheduled for surgical waitlist or outpatient treatment program. Having no obstacles for the planned assessments. Exclusion Criteria: Having received treatment for urinary incontinence in the last 3 months. Using medication specifically for urinary incontinence. Using medication for vaginal or urinary tract infections. Pregnancy. Being within the first 3 years postpartum. Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment. History of surgery that may impede the exercise planned within the scope of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevval Z Girit
Phone
05342009080
Email
giritzeynep@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevval Z Girit
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ipek Yeldan, Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Basaksehir Cam ve Sakura City Hospital
City
Istanbul
State/Province
Basaksehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunus Colakoglu, Dr
Phone
05079295687
Email
dr.yunusc@gmail.com
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Buyukcekmece
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ipek Yeldan, Prof.
Phone
05426513818
Email
ipek.yeldan@iuc.edu.tr
First Name & Middle Initial & Last Name & Degree
Sevval Z Girit
Phone
05342009080
Email
giritzeynep@gmail.com

12. IPD Sharing Statement

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Yoga and Pilates Based Respiratory Training Effect for Individuals With Urinary Incontinence

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