COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

NCT07336589 | Not Yet Recruiting

• 1 other identifier: FC-EXMASS-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Constipation (FC)

Keywords

Children; Exercise Therapy; Abdominal Massage; Pelvic Floor; Non-pharmacological Treatment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and after eight weeks

• 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.

  Baseline and after eight weeks

Secondary Outcomes (5)

• Bowel Function (Bowel Diary + Bristol Stool Scale)

  Baseline and after eight weeks

• Pelvic Floor Function

  Baseline and after eight weeks

• Quality of Life (Visual Analog Scale)

  Baseline and after eight weeks

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

  After eight weeks

• Treatment Adherence (Visual Analog Scale)

  After eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations.

Behavioral: Standard Care and Education

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program.

Other: Stretching, Strengthening, and Stabilization Exercises; Other: Abdominal Massage (I Love You Technique); Behavioral: Standard Care and Education; Other: Pelvic Floor Muscle Training; Other: Breathing Exercises

Interventions

Stretching, Strengthening, and Stabilization Exercises OTHER

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

Intervention Group

Abdominal Massage (I Love You Technique) OTHER

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

Intervention Group

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.

Control Group; Intervention Group

Pelvic Floor Muscle Training OTHER

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

Intervention Group

Breathing Exercises OTHER

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

Intervention Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeynep Idil Sevimli: lead

Study Sites (1)

Ankara Bilkent City Hospital - Pediatric Surgery Clinic

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Standard of Care; Educational Status; Breathing Exercises

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Socioeconomic Factors; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Zeynep I sevimli, PT, MSc

  Fizyofit Pilates Stüdyosu / Ankara Bilkent City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep I sevimli, PT, MSc

CONTACT

+905063720373; idilsevimli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, MSc (Sponsor-Investigator)

Model Details: Participants will be randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)