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Not yet recruiting NCT07336589

COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

No phase Interventional Functional Constipation (FC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stretching, Strengthening, and Stabilization Exercises, Abdominal Massage (I Love You Technique), Standard Care and Education, Pelvic Floor Muscle Training.
Who it may be relevant to
Registry conditions: Functional Constipation (FC). Basic parameters: 5 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Stretching, Strengthening, and Stabilization Exercises
    Children will complete exercises to improve flexibility, muscle strength, and trunk stability.
  • Other Abdominal Massage (I Love You Technique)
    Gentle abdominal massage will be applied following the colon pathway to support bowel movement.
  • Behavioral 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.
  • Other Pelvic Floor Muscle Training
    Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance.
  • Other Breathing Exercises
    Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination.

Primary outcome measures

  • Rectal Diameter (measured by ultrasound) [Time frame: Baseline and after eight weeks]
  • Constipation Symptoms (Rome IV Diagnostic Criteria) [Time frame: Baseline and after eight weeks]
Secondary outcome measures (5)
  • Bowel Function (Bowel Diary + Bristol Stool Scale) [Time frame: Baseline and after eight weeks]
  • Pelvic Floor Function [Time frame: Baseline and after eight weeks]
  • Quality of Life (Visual Analog Scale) [Time frame: Baseline and after eight weeks]
  • Perceived Improvement (9-Point Patient Global Impression of Change Scale) [Time frame: After eight weeks]
  • Treatment Adherence (Visual Analog Scale) [Time frame: After eight weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital - Pediatric Surgery Clinic — Ankara

Identifiers

NCT: NCT07336589 · FC-EXMASS-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗