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NCT Number: NCT07336589

COMBINED EXERCISE AND MASSAGE PROGRAM 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.

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Key information

Conditions

Functional Constipation (FC)

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital - Pediatric Surgery Clinic

Ankara, Turkey (Türkiye)

Location contact

Zeynep I sevimli, PT, MSc

CONTACT

[email protected]

05063720373

Zeynep I sevimli, PT, MSc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stretching, Strengthening, and Stabilization Exercises

Other

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

Abdominal Massage (I Love You Technique)

Other

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

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

Breathing exercises

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep I sevimli, PT, MSc

CONTACT

[email protected]

+905063720373

Sponsors and collaborators

Lead sponsor

Zeynep Idil Sevimli

Other

Registry information

Official study title

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

Acronym: FC-EXMASS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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