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Účinky stabilizace páteře na pánevní dno u žen s roztroušenou sklerózou

25. září 2026 aktualizováno: Gözde TEKİN, Abant Izzet Baysal University

Zkoumání účinků cvičení pro stabilizaci páteře zaměřené na pánevní dno na stabilitu jádra, příznaky moči a svalové funkce pánevního dna u žen s roztroušenou sklerózou a příznaky dolních močových cest

The purpose of this study was to investigate the effects of spinal stabilization exercises focusing on the pelvic floor on core stability, urinary symptoms and pelvic floor muscle function in women with Multiple Sclerosis and lower urinary tract symptoms. Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor. Outcome measures will be assessed pre- and post-intervention using validated instruments.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

In multiple sclerosis (MS), disruption of the neural pathways responsible for bladder control leads to the development of lower urinary tract symptoms (LUTS). These symptoms, observed in approximately 32-96% of individuals with MS, have a significant negative impact on quality of life. Conservative management of LUTS includes lifestyle modifications, bladder training, and pelvic floor muscle training (PFMT). Although the effectiveness of PFMT has been demonstrated, there is no standardized protocol regarding exercise type or duration, indicating a gap in the literature concerning the identification of the most effective approach. Moreover, existing studies emphasize that the effective contraction of pelvic floor muscles requires the simultaneous activation of deep core muscles, particularly the transversus abdominis. This suggests that pelvic floor rehabilitation without the involvement of abdominal muscles may be insufficient. Spinal stabilization exercises target deep core muscles to enhance neuromuscular control, strength, and endurance. Recently, "spinal stabilization exercises focusing on the pelvic floor" have emerged as a promising strategy in the management of urinary incontinence. However, research on trunk control in individuals with MS remains limited and primarily focuses on neurological symptoms, with minimal attention given to LUTS and pelvic floor function.

This study is designed as a prospective, randomized controlled trial to evaluate the effects of spinal stabilization exercises focusing on the pelvic floor, delivered in addition to PFMT, on core stability, urinary symptoms, and pelvic floor muscle function in women with MS and LUTS. Eligible participants who consent to join the study will be randomly allocated into two groups using block randomization. The control group will receive PFMT alone, while the experimental group will receive PFMT combined with spinal stabilization exercises focusing on the pelvic floor . Both interventions will be delivered three times per week for eight weeks. Primary and secondary outcomes will be assessed using validated objective and subjective tools at baseline and post-intervention.

Typ studie

Intervenční

Zápis (Aktuální)

49

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Bolu
      • Merkez, Bolu, Turecko (Türkiye), 14030
        • Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Female participants aged between 18 and 65 years
  • Being diagnosed with Multiple Sclerosis by a specialist neurologist and having lower urinary system symptoms [Overactive Bladder-V8 scale score ≥ 9 and having at least two of the lower urinary system symptoms (urinary incontinence, nocturia, daytime urination frequency >8, storage symptoms such as sudden feeling of tightness, intermittent urination, slow urine flow and emptying symptoms such as incomplete emptying)
  • Being in the mild or moderate stage of the disease (Expanded Disability Status Scale (EDSS) score ˂ 6
  • No relapse experienced within the past month
  • Scoring 24 or above on the Mini-Mental State Examination (MMSE)
  • Being literate
  • Willingness to voluntarily participate in the study
  • Ability to perform voluntary pelvic floor muscle contractions
  • No changes in medical treatment within the past three months
  • Ability to understand and cooperate with the assessments and interventions involved in the study

Exclusion Criteria:

  • Diagnosis of one or more neurological disorders other than Multiple Sclerosis
  • Body mass index (BMI) ≥ 30
  • Diagnosis of overflow urinary incontinence
  • History of antimuscarinic medication use
  • Presence of advanced pelvic organ prolapse (stage ≥ 2)
  • Active urinary tract infection
  • History of cesarean section or vaginal delivery within the past 6 months
  • Diagnosis of any other neurological condition that may cause urinary incontinence
  • History of urological or gynecological surgery
  • History of malignancy
  • Currently pregnant or not sexually active (coitus negative)
  • Participation in exercise training or physical therapy for lower urinary tract symptoms within the past 6 months

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Pelvic floor muscle exercises

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

Experimentální: Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises

Spinal stabilization exercises focusing on the pelvic floor will be administered under physiotherapist supervision three times per week for eight weeks. Each session will consist of 5 minutes of warm-up, 30 minutes of pelvic floor-focused spinal stabilization exercises, and 5 minutes of cool-down. Stabilization and posture training will be provided at the outset, including instruction on identifying the neutral position of the spine to ensure proper posture. Correct pelvic floor muscle contraction and abdominal bracing techniques will be demonstrated. The exercise program will comprise three phases: static (weeks 1-2), dynamic (weeks 3-5), and functional (weeks 6-8). Throughout all exercises, participants will maintain a neutral spine position and abdominal bracing, with contractions held for 5-10 seconds and repeated 10 times. Additionally, participants will be instructed to continue pelvic floor exercises as a home program on non-supervised days.

This program consists of 3 phases: 30 minutes of spinal stabilization exercises focusing on the pelvic floor, 5 minutes of warm-up and 5 minutes of cool-down exercises.The exercises will consist of 3 phases: static, dynamic and functional phases. Individuals will perform static phase exercises for the first 2 weeks, then dynamic phase exercises in the 3rd and 5th weeks and finally functional phase exercise in the 6th and 8th weeks. Individuals will be asked to maintain neutral spine position and abdominal bracing during pelvic floor muscle contraction during all exercises. Individuals will maintain the contraction for 5-10 seconds for 10 repetitions in each position in all phases.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evaluation of Urinary Symptoms
Časové okno: 8 week

Urinary symptoms will be assessed with the International Incontinence Questionnaire Short Form. The International Incontinence Questionnaire Short Form consists of a total of six questions. The total score is obtained by summing the scores of questions 3, 4 and 5. Scores that can be obtained from the scale vary between 0-21; a low score indicates that urinary incontinence affects quality of life a little, while a high score indicates that it affects it a lot.

8 week
Evaluation of Bladder Functions
Časové okno: 8 week

A bladder diary will be used to assess bladder function for lower urinary tract symptoms. Patients will be asked to complete a 24-hour bladder diary on three non-consecutive days. Average day-night voiding frequency, voiding volume and number of urinary incontinence will be calculated by averaging the three daily urinary diaries.

8 week

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evaluation of the degree of urinary symptoms
Časové okno: 8 week

Overactive Bladder-Version8 will be used to assess the degree of lower urinary system symptoms due to overactive bladder. The score to be obtained from the scale ranges from "0" the best to "40" the worst. If the total score on the scale is more than 8, the subjects are considered to have possible lower urinary tract symptoms.

8 week
Evaluation of Pelvic Floor Muscle Function
Časové okno: 8 week

Pelvic floor muscle function will be evaluated with the 632 Myomed biofeedback device. The pressure probe and device will be disinfected in each individual before the application and the probe will be used with a condom to ensure the hygiene of the individual. During the assessment, the pressure probe will be inserted intravaginally while the individual is supine, knees bent and slightly apart. Assessment results will be recorded in hectopascal.

8 week
Evaluation of pelvic floor muscle strength
Časové okno: 8 week

Vaginal palpation method will be used to measure pelvic floor muscle strength. The assessment will be performed in supine position, with hips and knees flexed and soles of the feet in contact with the bed. After taking the necessary hygiene measures, the physiotherapist will place the index and middle finger intravaginally. The individual will then be asked to pinch the physiotherapist's fingers and pull upwards for pelvic floor muscle contraction. The outcome value will be scored with the Modified Oxford grading system.

8 week
Evaluation of the endurance of the lateral core muscles
Časové okno: 8 week

The lateral bridge test will be used to assess the endurance of the lateral core muscles. Individuals will be asked to place their forearms and feet on the side of one side in a position to carry their body weight, then they will be asked to maintain this position by lifting their hips from the bed. The test will be terminated when the proper posture is broken or the pelvis falls on the bed, and the time from maintaining the proper position to breaking the position will be recorded in seconds. The test will be performed separately on the right and left side.

8 week
Evaluation of the endurance of the anterior core muscles
Časové okno: 8 week

Flexor endurance test will be used to assess the endurance of the anterior core muscles. Individuals will be placed on the bed with their trunk at 60°, knees and hips at 90° flexion and supported by their feet. In this position, the time in seconds will be recorded until they lose 60° of trunk flexion.

8 week
Evaluation of endurance of the posterior core muscles
Časové okno: 8 week

The extensor endurance test will be used to evaluate the endurance of the posterior core muscles. Individuals will lie in a prone position with pelvis, hips and knees supported on the bed and the upper trunk will be positioned on the edge of the bed in a straight, slightly extended position. Individuals will be stabilized by their feet. The test will be terminated when the trunk falls from the horizontal position to flexion and the time in this position will be recorded in seconds.

8 week
Evaluation of Deep Lumbar Muscular Strength
Časové okno: 8 week

Stabilizer Pressure Biofeedback device will be used to assess deep lumbar muscular strength. Individuals will be asked to lie in a prone position and keep their knees in a straight position, their spine straight and their head in a comfortable position. The cushion of the measuring device will be placed under their abdominal area with the air completely deflated. After the manometer needle is set to 70 mm/Hg, the individuals will be asked to contract the transversus abdominous muscles for 5 seconds as taught. The test will be performed for 10 s and 3 repetitions and the average of the results of the 3 tests will be recorded in mm/Hg.

8 week
Evaluation of Quality of Life
Časové okno: 8 week

King Health Questionnaire will be used to assess quality of life. The questionnaire consists of two parts and includes 32 items. . On the complaint severity scale, the best score is "0" and the worst score is "30". In other subsections of the King Health Questionnaire, the best score is "0" and the worst score is "100".

8 week
Evaluation of Subjective Perception of Recovery
Časové okno: 8 week

The Global Perceived Impact scale will be used to assess the subjective perception of improvement after the training. Participants will be asked to rate on a scale of 1 to 9 the extent to which their complaints have improved compared to before the training. The description of the scores is; '1' 'much improved', '2' 'much improved', '3' 'moderately improved', '4' 'slightly improved', '5' 'unchanged', '6' 'slightly worsened', '7' 'moderately worsened', '8' 'much worsened', '9' 'much worsened'.

8 week
Evaluation of Perceived Health Problem
Časové okno: 8 week

The health problem perceived by individuals will be assessed with the Patient-specific complaints instrument. The numbered classification scale-11 (0-10) will be used for scoring. The individual will be asked to give a score between 0-10 for the severity of the problem caused by lower urinary tract symptoms as perceived by the individual. 0 means "no complaint at all" and 10 means "very severe complaint".

8 week
Evaluation of Compliance with Training
Časové okno: 8 week

The compliance of the individuals with the training will be evaluated using a 10-centimeter visual analog scale. At the end of the study, the individuals in the control and experimental groups will be asked to evaluate the training program given to them by marking the place that best expresses themselves on a 10 cm line between 0 (I did not apply the treatment given at all) and 10 (I applied the treatment given completely). The distance between the marked point and the starting point will be recorded.

8 week

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: gözde tekin, Msc, Abant Izzet Baysal University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. června 2025

Primární dokončení (Aktuální)

23. ledna 2026

Dokončení studie (Aktuální)

23. ledna 2026

Termíny zápisu do studia

První předloženo

25. června 2025

První předloženo, které splnilo kritéria kontroly kvality

10. července 2025

První zveřejněno (Aktuální)

20. července 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • AİBU-FTR-GT-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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