Yoga and Pilates Based Respiratory Training Effect for Individuals with Urinary Incontinence
Comparison of Yoga-Based and Pilates-Based Respiratory Training Effect for Individuals with Urinary Incontinence
1 other identifier
interventional
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2023
CompletedFirst Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedOctober 10, 2024
May 1, 2024
11 months
September 19, 2023
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
baseline and post-intervention (7th week)
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.
baseline and post-intervention (7th week)
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.
baseline and post-intervention (7th week)
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.
baseline and post-intervention (7th week)
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.
baseline and post-intervention (7th week)
Secondary Outcomes (2)
Core Muscle Endurance Assessment
baseline and post-intervention (7th week)
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
baseline and post-intervention (7th week)
Study Arms (2)
Yoga-based Respiration Group
EXPERIMENTALThis group will be given yoga-based breathing exercises
Pilates-based Respiration Group
EXPERIMENTALThis group will be given pilates-based breathing exercises
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Having the diagnosis of stress or mixed urinary incontinence.
- Being volunteer to participate in the study.
- Having planned routine treatment program and being compliant with treatment
- Having no obstacles for the planned assessments.
- People who capable of written, verbal and visual communication
You may not qualify if:
- Having received treatment for urinary incontinence in the last 3 months.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Basaksehir Cam ve Sakura City Hospital
Istanbul, Basaksehir, Turkey (Türkiye)
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sevval Z Girit
Istanbul University - Cerrahpasa
- STUDY CHAIR
Ipek Yeldan, Prof.
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
September 19, 2023
First Posted
September 26, 2023
Study Start
August 7, 2023
Primary Completion
June 30, 2024
Study Completion
July 30, 2024
Last Updated
October 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share