Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Bladder-Related Pain Severity
研究概览
简要总结
The goal of this clinical trial is to learn if aerobic exercise training and connective tissue massage, in addition to patient education, can help treat women with bladder pain syndrome. The main questions it aims to answer are:
Does aerobic exercise training and connective tissue massage reduce bladder-related pain severity?
Does this intervention improve urinary symptoms, pain sensitivity, central sensitization-related symptoms, psychological symptoms, and quality of life?
Researchers will compare patient education plus aerobic exercise training and connective tissue massage with patient education alone to see if the combined physiotherapy program is more effective.
Participants will:
Receive patient education about bladder pain syndrome
Be randomly assigned to one of two groups
Receive either patient education alone or patient education together with aerobic exercise training and connective tissue massage for 8 weeks
Complete assessments at the beginning of the study and after 8 weeks
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
Outcome assessments will be performed by an assessor who is blinded to group allocation. Due to the nature of the physiotherapy interventions, participants and the care provider delivering the intervention cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female individuals aged 18 years or older
- •Diagnosis of bladder pain syndrome
- •Bladder-related pain, discomfort, and/or burning symptoms lasting for at least 6 months
- •Bladder-related symptom severity, including pain, discomfort, and/or burning, of at least 3 cm on the Visual Analog Scale during the last week
- •Receiving stable medical treatment
- •Being medically suitable for moderate-intensity aerobic exercise according to the Physical Activity Readiness Questionnaire
- •Volunteering to participate in the study and signing the informed consent form
- •For individuals aged 65 years or older, a Mini-Mental State Examination score of 24 or higher
排除标准
- •Presence of acute urinary tract or urogynecological infection
- •Pregnancy and/or breastfeeding
- •Diagnosis of pelvic, urological, and/or gynecological malignancy or history of pelvic radiotherapy
- •Pelvic or abdominal surgery within the last 6 months
- •Presence of congenital urinary system anomalies
- •History of neurological disease or diagnosis of neurogenic bladder
- •Open wound or active skin infection in the area where manual therapy will be applied
研究组 & 干预措施
Patient Education + Multimodal Physiotherapy
Participants in this group will receive patient education together with an 8-week multimodal physiotherapy program including aerobic exercise training and connective tissue massage. The interventions will be delivered according to the planned protocol. Each session will last approximately 70 to 75 minutes.
干预措施: Patient Education (Behavioral)
Patient Education + Multimodal Physiotherapy
Participants in this group will receive patient education together with an 8-week multimodal physiotherapy program including aerobic exercise training and connective tissue massage. The interventions will be delivered according to the planned protocol. Each session will last approximately 70 to 75 minutes.
干预措施: Aerobic Exercise Training (Behavioral)
Patient Education + Multimodal Physiotherapy
Participants in this group will receive patient education together with an 8-week multimodal physiotherapy program including aerobic exercise training and connective tissue massage. The interventions will be delivered according to the planned protocol. Each session will last approximately 70 to 75 minutes.
干预措施: Connective Tissue Massage (Other)
Patient Education
Participants in this group will receive patient education alone. During the study period, participants will be followed at regular two-week intervals. During these follow-ups, symptom status will be checked and brief reminders about lifestyle and symptom management recommendations provided during patient education will be given.
干预措施: Patient Education (Behavioral)
结局指标
主要结局
Change in Bladder-Related Pain Severity
时间窗: Baseline and 8 weeks
Bladder-related pain severity will be assessed using a 10-cm Visual Analog Scale. Participants will be asked to mark the point that best represents the most severe bladder-related pain or pain-like discomfort, such as burning, pressure, or discomfort, experienced during the last three days. Scores range from 0 to 10, with higher scores indicating greater pain severity.
次要结局
- Change in Bladder Pain Syndrome-Related Symptom Severity(Baseline and 8 weeks)
- Change in Bladder Pain Syndrome-Related Problem Severity(Baseline and 8 weeks)
- Change in Pressure Pain Threshold(Baseline and 8 weeks)
- Change in Conditioned Pain Modulation(Baseline and 8 weeks)
- Change in Central Sensitization-Related Symptoms(Baseline and 8 weeks)
- Change in Anxiety and Depression Symptoms(Baseline and 8 weeks)
- Change in Functional Exercise Capacity(Baseline and 8 weeks)
- Change in Health-Related Quality of Life(Baseline and 8 weeks)
- Subjective Perception of Change in Bladder-Related Pain Symptoms(At 8 weeks)
- Adherence to Exercise and Intervention(During the 8-week intervention period)
- Adherence to Lifestyle Recommendations(At 8 weeks)
研究者
SERAP ÖZGÜL
Prof. Dr.
Hacettepe University