Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652178
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Pelvic Floor Muscle Activity Respiratory Functions Respiratory Muscle Strength and Functional Capacity in Children with Lower Urinary Tract Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Pelvic Floor Muscle Activity Respiratory Functions Respiratory Muscle Strength and Functional Capacity in Children with Lower Urinary Tract Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The functional disorders of the lower urinary tract in children involve overactive bladder with thickening of the bladder muscle resulting in a decrease in functional bladder volume and an increase in intra-bladder pressure Lower urinary tract dysfunction in children most commonly develops due to non-neuropathic bladder sphincter dysfunction Pelvic floor disorders is a term used to describe various diseases including mild moderate and severe impairment of the pelvic floor muscles Pelvic floor disorders become a condition that causes some symptoms such as involuntary urinary and faecalgas incontinence urgency and pelvic pain due to increased pressure of the pelvic floor muscles Although the symptoms experienced may be permanent they usually last throughout the day
Electromyography EMG is a well-known non-invasive and practical method for relative pelvic floor muscle activity Standardised endurance tests will be used for core muscle endurance measurements Pulmonary function tests help to determine the severity of functional impairments and the extent to which treatment restores normal function It has been reported that respiratory muscle strength tests can be used to monitor the effect of various diseases on muscle strength especially considering their variations in the normal population The six-minute walk test which is used in the assessment of functional capacity is frequently used in a wide range of different populations including children because it is easy to perform has a low cost and especially shows exercise capacity The six-minute walk test is an important indicator of aerobic endurance which is one of the basic components of physical fitness
The findings of this project will provide to see whether pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity of children with lower urinary tract dysfunction differ from healthy children of the same age The lack of a study on this subject suggests that this study would be an important contribution to the literature In the present study it was aimed to evaluate pelvic floor muscle activity with a superficial EMG device core strength-endurance with core muscle endurance tests respiratory functions with a spirometer pulmonary function test respiratory muscle strength MIPMEP with an intraoral pressure measuring device and functional capacity with a six-minute walk test Determining how lower urinary tract dysfunction affects pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity and the extent to which it affects the daily life of the individual is important Furthermore it is also considered that this project may provide valuable insight into how important it is to follow up the development of children with lower urinary tract dysfunction The hypotheses of this study are as follows
Hypotheses
H1 Children with lower urinary tract dysfunction have poor pelvic floor muscle activity compared to healthy children
H2 Children with lower urinary tract dysfunction have lower respiratory function than healthy children
H3 Children with lower urinary tract dysfunction have lower respiratory muscle strength than healthy children
H4 Children with lower urinary tract dysfunction have lower functional capacity than healthy children
Electromyography EMG is a well-known non-invasive and practical method for relative pelvic floor muscle activity Standardised endurance tests will be used for core muscle endurance measurements Pulmonary function tests help to determine the severity of functional impairments and the extent to which treatment restores normal function It has been reported that respiratory muscle strength tests can be used to monitor the effect of various diseases on muscle strength especially considering their variations in the normal population The six-minute walk test which is used in the assessment of functional capacity is frequently used in a wide range of different populations including children because it is easy to perform has a low cost and especially shows exercise capacity The six-minute walk test is an important indicator of aerobic endurance which is one of the basic components of physical fitness
The findings of this project will provide to see whether pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity of children with lower urinary tract dysfunction differ from healthy children of the same age The lack of a study on this subject suggests that this study would be an important contribution to the literature In the present study it was aimed to evaluate pelvic floor muscle activity with a superficial EMG device core strength-endurance with core muscle endurance tests respiratory functions with a spirometer pulmonary function test respiratory muscle strength MIPMEP with an intraoral pressure measuring device and functional capacity with a six-minute walk test Determining how lower urinary tract dysfunction affects pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity and the extent to which it affects the daily life of the individual is important Furthermore it is also considered that this project may provide valuable insight into how important it is to follow up the development of children with lower urinary tract dysfunction The hypotheses of this study are as follows
Hypotheses
H1 Children with lower urinary tract dysfunction have poor pelvic floor muscle activity compared to healthy children
H2 Children with lower urinary tract dysfunction have lower respiratory function than healthy children
H3 Children with lower urinary tract dysfunction have lower respiratory muscle strength than healthy children
H4 Children with lower urinary tract dysfunction have lower functional capacity than healthy children
Detailed Description:
Normal bladder function is essential for physical and psychosocial development in all children The bladder has two main functions storage and emptying Bladder compliance is an important parameter for normal storage For normal emptying urinary continence until emptying and adequate emptying of stored urine under voluntary control are required This task is achieved by coordination of the detrusor muscle of the bladder with the bladder neck or internal sphincter and voluntary external sphincter Complete emptying of the bladder is achieved by adequate contraction Incompatibility between the detrusor muscle and sphincter muscles may cause permanent damage by disrupting bladder functions Lower urinary system dysfunction is categorized in three main groups as dysfunctional voiding overactive bladder and underactive bladder In addition laughing incontinence Hinman syndrome and vaginal reflux incontinence which are rarely encountered are also considered as lower urinary tract dysfunction Lower urinary tract dysfunction in children is often due to non-neuropathic bladder sphincter dysfunction Uninhibitable detrusor contractions overactive bladder and dysfunction of the pelvic floor muscles dysfunctional voiding are causes of lower urinary tract dysfunction Lower urinary tract dysfunction is also defined as involuntary daytime urinary incontinence in children aged five years and older due to non-organic functional causes Adequate bladder sphincter control and sphincter-detrusor compliance reach full maturity only around the age of four years Normal daytime control of bladder function matures between 2-3 years of age whereas nocturnal control is normally achieved between 3-7 years of age It is known that symptoms of lower urinary tract dysfunction peak between 5-7 years of age It has been shown in the literature that the frequency of lower urinary tract dysfunction is higher in patients with a family history Especially if the mother or sibling has lower urinary tract dysfunction the risk increases even more Clinically lower urinary tract dysfunction may present with various lower urinary tract symptoms such as urgency urinary incontinence frequent urination dribbling and feeling of incomplete urinary emptying without an underlying uropathy or neuropathy Studies have reported that the prevalence of lower urinary tract dysfunction is between 6-46 Children with lower urinary tract dysfunction constitute 40 of the patients admitted to pediatric urology specialists It is 5 times more common in girls than boys
The pelvic floor muscles are divided into three layers consisting of deep middle and superficial perineal muscles that extend from the symphysis pubis along the anterior lateral walls of the ilium towards the coccyx The superficial layer includes bulbospongiosus ischocavernosus transversus perinei superfisialis and sphincter ani externus muscles the middle layer includes sphincter urethra external anal sphincter and transversus perinei profundus muscles In the deep layer there are levator ani and coccygeus muscles The pelvic floor muscles are responsible for voiding defecation sexual function and support of the pelvic organs In addition to these tasks they also contribute to maintaining trunk stability When the pelvic floor muscles contract the perineum moves ventrally and cranially closing the openings of the anus vagina and urethra These contractions are important in preventing involuntary leakage of urine and feces A correct pelvic floor muscle contraction has been shown to increase urethral pressure Pelvic floor dysfunction is an umbrella term characterized by different and complex symptoms
Respiratory muscles and force ventilatory muscles are divided into two classes primary and accessory muscles The diaphragm is the main primary muscle and is active in normal breathing The costae and diaphragm work together to produce three-dimensional changes in chest volume During rest only the inspiratory muscles are active During exercise the expiratory muscles also become active The diaphragm contracts and flattens during normal respiration to allow inspiration it then relaxes and returns to its resting shape during expiration Vigorous expiration below the resting level also requires contraction of the abdominal muscles The diaphragm intercostal muscles TA multifidus and pelvic floor muscles are core stabilization muscles involved in postural function as well as being used for respiration Daily physical activities require postural control and specific movement components Many muscles in the core are important for postural smoothness and postural control during activities
The diaphragm descends with inspiration to increase the pressure within the abdominal cavity thus increasing the relaxation of the diaphragm improving lung function and stabilizing the trunk The pelvic floor muscle is activated by the increase in intra-abdominal pressure due to the action of the diaphragm so that the TA muscle is easily activated by abdominal contraction during respiration It shows that activation of the pelvic floor muscle and TA muscle facilitates stabilization of the thoracic cage and lumbar region and leads to improved respiratory function These results suggest that it is important to ensure lumbar spine stabilization by increasing intra-abdominal pressure while focusing on diaphragmatic breathing and activation of core structures to transfer force from the center of the body to the lower extremities It has been suggested that abdominal contraction during respiration activates the TA external oblique internal oblique and multifidus muscles more easily Muscle tone of the diaphragm and TA muscle is particularly important to stabilize the lumbar region
The diaphragm TA and pelvic floor muscles are important for motor control postural support and respiration Their dysfunction results in back pain and an increased risk of injury The respiratory function of these muscles needs to be integrated with many other functions such as swallowing speech valsalva maneuvers spinal stabilization and trunk and limb movement In situations of increased respiratory demand such as stress illness or physical exercise the ability of the respiratory muscles to perform their postural tasks is reduced
Spirometric measurement is the most widely used test of pulmonary function It is a measurement of the maximum airflow to fill the lungs with sudden expiration after deep inspiration It can provide information about the size of the airways usually large airways and the presence of obstructions in the airflow The measurements obtained from spirometry are FVC forced vital capacity The total volume of air that can be inhaled during a maximal forced expiration FEV1 Forced expiratory volume in seconds is the volume expired in the first second of maximal expiration FEV1FVC The ratio of volume expired in one second to FVC PEF Peak expiratory flow represents the maximum expiratory flow rate achieved FEF25-75 The mean expired flow in the middle half of the FVC
Respiratory muscle strength measurement methods are used to measure the strength of inspiratory and expiratory respiratory muscles The most common areas of use are diagnosis determination of severity and follow-up of respiratory muscle weakness The easiest and most commonly used method to measure respiratory muscle strength is maximal inspiratory and expiratory intra-oral pressure measurements measured during airway opening with voluntary contraction against the closed airway Maximal inspiratory intra-oral pressure MIP indicates inspiratory muscle force After maximal expiration in the sitting position the nose is closed with a nose clip and the person is asked to perform maximal inspiration for at least 15 s against the closed lid The measurement is repeated 3 times and the highest value is taken Maximal expiratory intraoral pressure MEP indicates expiratory muscle strength After maximum inspiration in the sitting position the person whose nose is closed with a nose clip is asked to perform maximum expiration for at least 15 s against the closed valve The measurement is repeated 3 times and the highest value is taken
The six-minute walk test which is used in the assessment of functional capacity is frequently used in a wide range of populations including children because it is easy to perform low cost and especially because it also shows exercise capacity The six-minute walk test is an important indicator of aerobic endurance one of the main components of physical fitness
The results the investigators will obtain with the project will allow to see how individuals with lower urinary tract dysfunction in children have an effect on pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity compared to healthy individuals of the same age Based on the lack of research on this subject and the lack of research on this subject in the literature the study will make an important contribution to the literature The investigators also think that this project can provide information on how important it is to follow the development of children with lower urinary tract dysfunction The project is considered to fill an important gap in the literature in this regard The aim with the project is to evaluate pelvic floor muscle activity respiratory function respiratory muscle strength and functional capacity in children with lower urinary tract dysfunction In the study it is aimed to measure pelvic floor muscle activity with a superficial EMG device core strength-endurance with core muscle endurance tests respiratory function with a spirometer pulmonary function test respiratory muscle strength MIPMEP with an intraoral pressure measuring device and functional capacity with a six-minute walk test
The pelvic floor muscles are divided into three layers consisting of deep middle and superficial perineal muscles that extend from the symphysis pubis along the anterior lateral walls of the ilium towards the coccyx The superficial layer includes bulbospongiosus ischocavernosus transversus perinei superfisialis and sphincter ani externus muscles the middle layer includes sphincter urethra external anal sphincter and transversus perinei profundus muscles In the deep layer there are levator ani and coccygeus muscles The pelvic floor muscles are responsible for voiding defecation sexual function and support of the pelvic organs In addition to these tasks they also contribute to maintaining trunk stability When the pelvic floor muscles contract the perineum moves ventrally and cranially closing the openings of the anus vagina and urethra These contractions are important in preventing involuntary leakage of urine and feces A correct pelvic floor muscle contraction has been shown to increase urethral pressure Pelvic floor dysfunction is an umbrella term characterized by different and complex symptoms
Respiratory muscles and force ventilatory muscles are divided into two classes primary and accessory muscles The diaphragm is the main primary muscle and is active in normal breathing The costae and diaphragm work together to produce three-dimensional changes in chest volume During rest only the inspiratory muscles are active During exercise the expiratory muscles also become active The diaphragm contracts and flattens during normal respiration to allow inspiration it then relaxes and returns to its resting shape during expiration Vigorous expiration below the resting level also requires contraction of the abdominal muscles The diaphragm intercostal muscles TA multifidus and pelvic floor muscles are core stabilization muscles involved in postural function as well as being used for respiration Daily physical activities require postural control and specific movement components Many muscles in the core are important for postural smoothness and postural control during activities
The diaphragm descends with inspiration to increase the pressure within the abdominal cavity thus increasing the relaxation of the diaphragm improving lung function and stabilizing the trunk The pelvic floor muscle is activated by the increase in intra-abdominal pressure due to the action of the diaphragm so that the TA muscle is easily activated by abdominal contraction during respiration It shows that activation of the pelvic floor muscle and TA muscle facilitates stabilization of the thoracic cage and lumbar region and leads to improved respiratory function These results suggest that it is important to ensure lumbar spine stabilization by increasing intra-abdominal pressure while focusing on diaphragmatic breathing and activation of core structures to transfer force from the center of the body to the lower extremities It has been suggested that abdominal contraction during respiration activates the TA external oblique internal oblique and multifidus muscles more easily Muscle tone of the diaphragm and TA muscle is particularly important to stabilize the lumbar region
The diaphragm TA and pelvic floor muscles are important for motor control postural support and respiration Their dysfunction results in back pain and an increased risk of injury The respiratory function of these muscles needs to be integrated with many other functions such as swallowing speech valsalva maneuvers spinal stabilization and trunk and limb movement In situations of increased respiratory demand such as stress illness or physical exercise the ability of the respiratory muscles to perform their postural tasks is reduced
Spirometric measurement is the most widely used test of pulmonary function It is a measurement of the maximum airflow to fill the lungs with sudden expiration after deep inspiration It can provide information about the size of the airways usually large airways and the presence of obstructions in the airflow The measurements obtained from spirometry are FVC forced vital capacity The total volume of air that can be inhaled during a maximal forced expiration FEV1 Forced expiratory volume in seconds is the volume expired in the first second of maximal expiration FEV1FVC The ratio of volume expired in one second to FVC PEF Peak expiratory flow represents the maximum expiratory flow rate achieved FEF25-75 The mean expired flow in the middle half of the FVC
Respiratory muscle strength measurement methods are used to measure the strength of inspiratory and expiratory respiratory muscles The most common areas of use are diagnosis determination of severity and follow-up of respiratory muscle weakness The easiest and most commonly used method to measure respiratory muscle strength is maximal inspiratory and expiratory intra-oral pressure measurements measured during airway opening with voluntary contraction against the closed airway Maximal inspiratory intra-oral pressure MIP indicates inspiratory muscle force After maximal expiration in the sitting position the nose is closed with a nose clip and the person is asked to perform maximal inspiration for at least 15 s against the closed lid The measurement is repeated 3 times and the highest value is taken Maximal expiratory intraoral pressure MEP indicates expiratory muscle strength After maximum inspiration in the sitting position the person whose nose is closed with a nose clip is asked to perform maximum expiration for at least 15 s against the closed valve The measurement is repeated 3 times and the highest value is taken
The six-minute walk test which is used in the assessment of functional capacity is frequently used in a wide range of populations including children because it is easy to perform low cost and especially because it also shows exercise capacity The six-minute walk test is an important indicator of aerobic endurance one of the main components of physical fitness
The results the investigators will obtain with the project will allow to see how individuals with lower urinary tract dysfunction in children have an effect on pelvic floor muscle activity respiratory functions respiratory muscle strength and functional capacity compared to healthy individuals of the same age Based on the lack of research on this subject and the lack of research on this subject in the literature the study will make an important contribution to the literature The investigators also think that this project can provide information on how important it is to follow the development of children with lower urinary tract dysfunction The project is considered to fill an important gap in the literature in this regard The aim with the project is to evaluate pelvic floor muscle activity respiratory function respiratory muscle strength and functional capacity in children with lower urinary tract dysfunction In the study it is aimed to measure pelvic floor muscle activity with a superficial EMG device core strength-endurance with core muscle endurance tests respiratory function with a spirometer pulmonary function test respiratory muscle strength MIPMEP with an intraoral pressure measuring device and functional capacity with a six-minute walk test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None