COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorZeynep Idil Sevimli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stretching, Strengthening, and Stabilization Exercises

    Other intervention

    Children will complete exercises to improve flexibility, muscle strength, and trunk stability.

  • Abdominal Massage (I Love You Technique)

    Other intervention

    Gentle abdominal massage will be applied following the colon pathway to support bowel movement.

  • Standard Care and Education

    Behavioral

    Children and their parents will receive education about bowel function and lifestyle guidance on diet, fluid intake, toileting habits, and physical activity.

  • Pelvic Floor Muscle Training

    Other intervention

    Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance.

  • Breathing Exercises

    Other intervention

    Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Rectal Diameter (measured by ultrasound)

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.

Time frame
Baseline and after eight weeks
2

Constipation Symptoms (Rome IV Diagnostic Criteria)

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.

Time frame
Baseline and after eight weeks

Secondary outcomes

1

Bowel Function (Bowel Diary + Bristol Stool Scale)

Bowel function will be evaluated using a 7-day bowel diary including stool frequency and stool consistency (Bristol Stool Scale, Types 1-7). The diary will be completed for one week at baseline and for one week after the 8-week program.

Time frame
Baseline and after eight weeks
2

Pelvic Floor Function

Pelvic floor muscle function will be evaluated using the Oxford Scale adapted for children. Muscle contraction strength will be graded during a clinical assessment.

Time frame
Baseline and after eight weeks
3

Quality of Life (Visual Analog Scale)

Children's and parents' quality of life will be measured using a Visual Analog Scale ranging from zero to ten, with higher scores indicating greater impact of constipation on daily life.

Time frame
Baseline and after eight weeks
4

Perceived Improvement (9-Point Patient Global Impression of Change Scale)

Perceived improvement will be evaluated using the 9-point Patient Global Impression of Change Scale. Parents will rate their child's overall change in constipation symptoms compared to the start of the study, with higher scores indicating greater improvement.

Time frame
After eight weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zeynep Idil Sevimli

Lead sponsor

Fizyofit Pilates Stüdyosu

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: