Functional Constipation (FC)FC-EXMASSNCT07336589
COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION
A study testing Stretching, Strengthening, and Stabilization Exercises, Abdominal Massage (I Love You Technique) and Pelvic Floor Muscle Training in people with Functional Constipation (FC), run by Zeynep Idil Sevimli at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Stretching, Strengthening, and Stabilization Exercises, Abdominal Massage (I Love You Technique) and Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital - Pediatric Surgery Clinic
Ankara, Ankara
Zeynep I sevimli, PT, MSc, 05063720373, idilsevimli@gmail.com
Zeynep I sevimli, PT, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Constipation (FC)
- Being tested
- Stretching, Strengthening, and Stabilization Exercises, Abdominal Massage (I Love You Technique), Standard Care and Education, Pelvic Floor Muscle Training, Breathing Exercises
- Keywords
- Children, Exercise Therapy, Abdominal Massage, Pelvic Floor, Non-pharmacological Treatment, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching, Strengthening, and Stabilization ExercisesOther
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 EducationBehavioural
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 TrainingOther
Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance.
Breathing ExercisesOther
Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after eight weeks
Secondary outcomes (5)
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.
Measured: Baseline and after eight weeks
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.
Measured: Baseline and after eight weeks
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.
Measured: Baseline and after eight weeks
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.
Measured: After eight weeks
Treatment Adherence (Visual Analog Scale)
Adherence to treatment recommendations will be evaluated using a Visual Analog Scale completed by parents, with higher scores indicating better adherence.
Measured: After eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Idil Sevimli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Idil Sevimli, Fizyofit Pilates Stüdyosu
- Investigators
- Zeynep I sevimli, PT, MSc, Principal investigator, Fizyofit Pilates Stüdyosu / Ankara Bilkent City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336589
- Sponsor's protocol ID
- FC-EXMASS-2025
- Acronym
- FC-EXMASS
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF A COMBINED EXERCISE TRAINING AND MASSAGE THERAPY IN CHILDREN WITH FUNCTIONAL CONSTIPATION
- ClinicalTrials.gov ID
- NCT07336589
- Acronym / sponsor ID
- FC-EXMASS / FC-EXMASS-2025
- Conditions
- Functional Constipation (FC)
- Keywords
- Children, Exercise Therapy, Abdominal Massage, Pelvic Floor, Non-pharmacological Treatment, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zeynep Idil SevimliUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Care and EducationParticipants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations. |
| Intervention Group | Experimental | 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 ExercisesParticipants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching, Strengthening, and Stabilization ExercisesChildren will complete exercises to improve flexibility, muscle strength, and trunk stability. | Other | Intervention Group |
| Abdominal Massage (I Love You Technique)Gentle abdominal massage will be applied following the colon pathway to support bowel movement. | Other | Intervention Group |
| Standard Care and EducationChildren and their parents will receive education about bowel function and lifestyle guidance on diet, fluid intake, toileting habits, and physical activity. | Behavioural | Control Group, Intervention Group |
| Pelvic Floor Muscle TrainingChildren will practice fast and slow pelvic floor contractions to improve muscle strength and endurance. | Other | Intervention Group |
| Breathing ExercisesChildren will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination. | Other | Intervention Group |
Primary outcome
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.
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.
5 secondary outcomes
Bowel Function (Bowel Diary + Bristol Stool Scale)
Time frame: Baseline and after eight weeks
Pelvic Floor Function
Time frame: Baseline and after eight weeks
Quality of Life (Visual Analog Scale)
Time frame: Baseline and after eight weeks
Perceived Improvement (9-Point Patient Global Impression of Change Scale)
Time frame: After eight weeks
Treatment Adherence (Visual Analog Scale)
Time frame: After eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep I sevimli, PT, MSc principal investigator
Fizyofit Pilates Stüdyosu / Ankara Bilkent City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching, Strengthening, and Stabilization Exercises, Abdominal Massage (I Love You Technique) and Pelvic Floor Muscle Training in people with Functional Constipation (FC), run by Zeynep Idil Sevimli at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep I sevimli, PT, MSc (+905063720373, idilsevimli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal Diameter (measured by ultrasound) (time frame: Baseline and after eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.