Investigation of 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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluation of Urinary Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to group allocation to minimize bias during post-intervention evaluations.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Pelvic floor muscle exercises (Behavioral)
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.
干预措施: Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises (Behavioral)
结局指标
主要结局
Evaluation of Urinary Symptoms
时间窗: 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.
Evaluation of Bladder Functions
时间窗: 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.
次要结局
- Evaluation of the degree of urinary symptoms(8 week)
- Evaluation of Pelvic Floor Muscle Function(8 week)
- Evaluation of pelvic floor muscle strength(8 week)
- Evaluation of the endurance of the lateral core muscles(8 week)
- Evaluation of the endurance of the anterior core muscles(8 week)
- Evaluation of endurance of the posterior core muscles(8 week)
- Evaluation of Deep Lumbar Muscular Strength(8 week)
- Evaluation of Quality of Life(8 week)
- Evaluation of Subjective Perception of Recovery(8 week)
- Evaluation of Perceived Health Problem(8 week)
- Evaluation of Compliance with Training(8 week)
研究者
Gözde TEKİN
Phd
Abant Izzet Baysal University