COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION (FC-EXMASS)

January 2, 2026 updated by: Zeynep Idil Sevimli

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye)
        • Ankara Bilkent City Hospital - Pediatric Surgery Clinic
        • Contact:
        • Sub-Investigator:
          • Zeynep I sevimli, PT, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Participants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations.
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.
Experimental: Intervention Group
Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rectal Diameter (measured by ultrasound)
Time Frame: 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.
Baseline and after eight weeks
Constipation Symptoms (Rome IV Diagnostic Criteria)
Time Frame: 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.
Baseline and after eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Function (Bowel Diary + Bristol Stool Scale)
Time Frame: Baseline and after eight weeks
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.
Baseline and after eight weeks
Pelvic Floor Function
Time Frame: Baseline and after eight weeks
Pelvic floor muscle function will be evaluated using the Oxford Scale adapted for children. Muscle contraction strength will be graded during a clinical assessment.
Baseline and after eight weeks
Quality of Life (Visual Analog Scale)
Time Frame: Baseline and after eight weeks
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.
Baseline and after eight weeks
Perceived Improvement (9-Point Patient Global Impression of Change Scale)
Time Frame: After eight weeks
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.
After eight weeks
Treatment Adherence (Visual Analog Scale)
Time Frame: After eight weeks
Adherence to treatment recommendations will be evaluated using a Visual Analog Scale completed by parents, with higher scores indicating better adherence.
After eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Idil Sevimli

Investigators

  • Principal Investigator: Zeynep I sevimli, PT, MSc, Fizyofit Pilates Stüdyosu / Ankara Bilkent City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC-EXMASS-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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