COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

Официальное название

THE EFFECTS OF A COMBINED EXERCISE TRAINING AND MASSAGE THERAPY IN CHILDREN WITH FUNCTIONAL CONSTIPATION

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Stretching, Strengthening, and Stabilization Exercises
  Children will complete exercises to improve flexibility, muscle strength, and trunk stability.
• Другое Abdominal Massage (I Love You Technique)
  Gentle abdominal massage will be applied following the colon pathway to support bowel movement.
• Поведенческое Standard Care and Education
  Children and their parents will receive education about bowel function and lifestyle guidance on diet, fluid intake, toileting habits, and physical activity.
• Другое Pelvic Floor Muscle Training
  Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance.
• Другое Breathing Exercises
  Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination.

Первичные конечные точки

• Rectal Diameter (measured by ultrasound) [Срок оценки: Baseline and after eight weeks]
• Constipation Symptoms (Rome IV Diagnostic Criteria) [Срок оценки: Baseline and after eight weeks]

Вторичные конечные точки (5)

• Bowel Function (Bowel Diary + Bristol Stool Scale) [Срок оценки: Baseline and after eight weeks]
• Pelvic Floor Function [Срок оценки: Baseline and after eight weeks]
• Quality of Life (Visual Analog Scale) [Срок оценки: Baseline and after eight weeks]
• Perceived Improvement (9-Point Patient Global Impression of Change Scale) [Срок оценки: After eight weeks]
• Treatment Adherence (Visual Analog Scale) [Срок оценки: After eight weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital - Pediatric Surgery Clinic — Ankara

Идентификаторы

NCT: NCT07336589 · FC-EXMASS-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗