Clinical trial NCT06054724: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
yoga
pilates
respiratory training
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 46
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: baseline and post-intervention (7th week)
measure: 24-Hour Pad Test
timeFrame: baseline and post-intervention (7th week)
measure: PFM Function- MyoPlusPro EMG Device
timeFrame: baseline and post-intervention (7th week)
measure: Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: baseline and post-intervention (7th week)
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: baseline and post-intervention (7th week)
Secondary outcomes:
measure: Core Muscle Endurance Assessment
timeFrame: baseline and post-intervention (7th week)
measure: Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
timeFrame: baseline and post-intervention (7th week)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura City Hospital
state: Basaksehir
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Buyukcekmece
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Sevval Z Girit
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ipek Yeldan, Prof.
role: STUDY_CHAIR
References: