Functional Constipation (FC)
Conditions
Keywords
Children, Exercise Therapy, Abdominal Massage, Pelvic Floor, Non-pharmacological Treatment, Randomized Controlled Trial
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.
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
OTHERStretching, Strengthening, and Stabilization Exercises
Children will complete exercises to improve flexibility, muscle strength, and trunk stability.
OTHERAbdominal Massage (I Love You Technique)
Gentle abdominal massage will be applied following the colon pathway to support bowel movement.
BEHAVIORALStandard 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.
OTHERPelvic Floor Muscle Training
Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance.
OTHERBreathing Exercises
Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination.
Sponsors
Zeynep Idil Sevimli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectal Diameter (measured by ultrasound) | 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. |
| Constipation Symptoms (Rome IV Diagnostic Criteria) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Visual Analog Scale) | 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. |
| Bowel Function (Bowel Diary + Bristol Stool Scale) | 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. |
| Treatment Adherence (Visual Analog Scale) | After eight weeks | Adherence to treatment recommendations will be evaluated using a Visual Analog Scale completed by parents, with higher scores indicating better adherence. |
| Perceived Improvement (9-Point Patient Global Impression of Change Scale) | 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. |
| Pelvic Floor Function | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactZeynep I sevimli, PT, MSc
Outcome results
None listed