THE EFFECTS OF A COMBINED EXERCISE TRAINING AND MASSAGE THERAPY IN CHILDREN WITH FUNCTIONAL CONSTIPATION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rectal Diameter (measured by ultrasound)
研究概览
简要总结
The goal of this clinical trial is to learn if a combined exercise and abdominal massage program improves bowel function and daily well-being in children with functional constipation. Researchers will compare this program with standard care by measuring bowel symptoms, rectal size, pelvic floor strength, trunk endurance, and quality of life.
详细描述
This clinical trial includes children with functional constipation. Participants will be randomly assigned to either a combined exercise and abdominal massage program or to standard care and education.
Children in the program group will take part in guided exercise sessions and receive abdominal massage, while the standard care group will receive routine follow-up and advice on bowel habits.
Researchers will measure bowel symptoms, bowel movement patterns, rectal diameter, pelvic floor muscle function, trunk muscle endurance, and quality of life before and after the program.
The results may help improve safe, non-drug treatment options for children with constipation.
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)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-18 years
- •Diagnosed with functional constipation according to Rome IV criteria
- •Voluntary participation with written informed consent obtained from parents or legal guardians
排除标准
- •Refusal to participate
- •Presence of congenital conditions (e.g., Down syndrome, Hirschsprung disease)
- •Endocrine or metabolic disorders (e.g., hypothyroidism, diabetes mellitus, diabetes insipidus)
- •Neurological or psychiatric disorders (e.g., spina bifida, cerebral palsy, autism spectrum disorders)
- •History of abdominal surgery within the last year
- •Presence of herniation or open wounds in the abdominal massage area
研究组 & 干预措施
Control Group
Participants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations.
干预措施: Standard Care and Education (Behavioral)
Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
干预措施: Stretching, Strengthening, and Stabilization Exercises (Other)
Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
干预措施: Abdominal Massage (I Love You Technique) (Other)
Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
干预措施: Standard Care and Education (Behavioral)
Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
干预措施: Pelvic Floor Muscle Training (Other)
Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
干预措施: Breathing Exercises (Other)
结局指标
主要结局
Rectal Diameter (measured by ultrasound)
时间窗: Baseline and after eight weeks
Rectal diameter will be measured using abdominal ultrasonography to assess rectal distension related to functional constipation. Measurements will be performed before the intervention and at the end of the eight-week program. Changes in rectal diameter will be used to evaluate the effectiveness of the combined exercise and abdominal massage program.
Constipation Symptoms (Rome IV Diagnostic Criteria)
时间窗: Baseline and after eight weeks
Constipation symptoms will be assessed using the Rome IV diagnostic criteria for functional constipation, including bowel movement frequency, fecal incontinence, painful or difficult defecation, stool withholding behavior, and presence of large stools.
次要结局
- Bowel Function (Bowel Diary + Bristol Stool Scale)(Baseline and after eight weeks)
- Pelvic Floor Function(Baseline and after eight weeks)
- Quality of Life (Visual Analog Scale)(Baseline and after eight weeks)
- Perceived Improvement (9-Point Patient Global Impression of Change Scale)(After eight weeks)
- Treatment Adherence (Visual Analog Scale)(After eight weeks)
研究者
Zeynep Idil Sevimli
Physiotherapist, MSc (Sponsor-Investigator)
Fizyofit Pilates Stüdyosu