ConstipationExerciseNCT06941103
Spinal Stabilization Exercise Training in Women With Chronic Constipation
A study testing Spinal stabilization exercise training and recommendation and Recommendation in people with Constipation, run by Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery, and spinal stability in women with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Spinal stabilization exercise training and recommendation and Recommendation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 25 Nov 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic functional constipation according to Rome 4 diagnostic criteria
- Those between the ages of 18-65
- Women who volunteer to participate in the study will be included.
Who cannot join
- Those who are pregnant or breastfeeding
- Neurological diseases (Parkinson, Multiple Sclerosis, hemiplegia, etc.)
- Undercontrolled systemic/metabolic diseases (hypothyroidism, diabetes mellitus, hypokalemia, hypercalcemia, hypomagnesemia, etc.)
- Malignant diseases
- Accompanying colon or gastrointestinal problems (gastrointestinal bleeding, acute inflammation, etc.)
- Secondary constipation presence of alarm symptoms (new onset constipation, rectal bleeding, involuntary weight loss, nausea, vomiting, fever, anemia or a family history of gastrointestinal malignancy)
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- Those who received treatment (exercise, surgery, etc.) for the abdominolumbopelvic region in the last year
- Having a history of colostomy or colectomy
- Those with orthopedic limitations that would affect spinal stabilization exercise training
- Those who do not participate in the treatment program regularly.
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
Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi
Ankara
About this study
Official title: Effects of Spinal Stabilization Exercise Training in Women With Chronic Constipation
This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery, and spinal stability in women with chronic constipation.
Read the detailed description
This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery and spinal stability in women with chronic constipation. Individuals' physical, demographic, lifestyle, medical characteristics and medications used will be questioned and recorded. Physical activity level will be questioned with the "International Physical Activity Questionnaire-Short Form (IPAQ-SF)". In addition, constipation severity will be evaluated before and after treatment with the "Constipation Severity Scale (CSS)", functional markers of the intestine "Stool Diary and Bristol Stool Scale", the effect of constipation on the quality of life "The Patient Assessment of Constipation Quality of Life (PAC-QOL)", spinal stability "Sahrmann Test" and trunk muscle endurance "McGill Core Endurance Tests". In addition, perception of recovery will be evaluated after treatment with the "Patient Global Impression of Improvement Scale" and compliance with the recommendation will be evaluated with the "Visual Analog Scale (VAS)". The control group will be given only suggestions, while the exercise group will be given suggestions and spinal stabilization exercise training. Within the scope of the recommendation, you will first be informed about the definition of constipation, risk factors, treatment methods, and recommendations on physical activity, nutrition (fiber and fluid intake) and defecation position will be given to reduce constipation complaints. A brochure will be prepared to be distributed to individuals regarding these issues. Spinal stabilization exercise training will be applied 3 days a week for 8 weeks under the supervision of a specialist physiotherapist. Exercises consist of a 5-10 minute warm-up period, 40 minutes spinal stabilization exercise training a 5-10 minute cool-down period.
- Conditions
- Constipation
- Being tested
- Spinal stabilization exercise training and recommendation, Recommendation
- Keywords
- spinal stabilization exercise, quality of life, spinal stability
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal stabilization exercise training and recommendationOther
Spinal stabilization exercise training will be applied 3 days a week for 8 weeks under the supervision of a specialist physiotherapist. Exercises consist of a 5-10 minute warm-up period, 40 minutes SSET and a 5-10 minute cool-down period.
Within the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues.
RecommendationOther
Within the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Spinal stabilization exercise training and recommendation Receives: Other: Spinal stabilization exercise training and recommendation; Other: Recommendation |
| Control group | Other | Recommendation Receives: Other: Recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Severity Scale (CSI)
Scale Varma et al. it was developed by to determine individuals' defecation frequency, intensity and difficulty experienced during defecation. Kaya et al. Turkish validity and reliability were conducted by . The scale consists of 16 questions and three sub-areas. These areas are 1. Fecal Obstruction, 2. Large Intestinal Laziness and 3. Pain. The lowest total score that can be obtained from the scale is 0 and the highest is 73. A high score indicates that the symptoms are serious.
Measured: two weeks
Secondary outcomes (5)
Spinal Stability Assessment
Spinal stability will be evaluated with the Sahrmann test and McGill trunk muscle endurance tests.
In the Sahrmann test, the Stabilizer Pressure Biofeedback Unit (Chattanooga, TN, USA) will be placed under the individuals' lumbar region and adjusted to 40mmHg. Individuals will be taught the abdominal bracing maneuver to ensure isolated contraction of the transversus abdominis muscle and spinal stability. Individuals will be asked to maintain abdominal bracing and perform different lower extremity movements at all levels of the test. The test consists of 5 levels and the difficulty level increases from level 1 to level 5. When the stabilizer value deviates more than 10 mmHg at each level, the test will be terminated, assuming that the person cannot complete that level.In McGill trunk muscle endurance tests, individuals will be subjected to trunk flexion, extension, right and left lateral flexion endurance tests.
Measured: two weeks
Patient Assessment Constipation-Quality of Life Scale (PAC-QOL)
Marquis et al. it was developed by (Marquis et al., 2005) in 2005, and its Turkish validity and reliability were tested by Dedeli et al. It was revealed by. The scale consists of 28 items and has 4 subdomains: "physical discomfort", "psychosocial discomfort", "worry/anxiety" and "satisfaction". The lowest score that can be obtained from the scale is 28 and the highest score is 140. Higher scores from the scale mean that the quality of life is more negatively affected.
Measured: two weeks
Bowel diary
Individuals will be asked to complete a bowel diary one week before starting treatment and for 7 days after the study is completed. In these diaries, they will be asked to mark each day they defecate, how long they spend in the toilet for each defecation, the feeling of incomplete defecation, the use of medication to defecate, changes in nutrition and fluid consumption, and pain during defecation . They will also be asked to record stool type according to the Bristol Stool Scale in their bowel diary. This scale was developed by Lewis and Heaton and human feces are classified into 7 groups. Since the shape of the stool changes depending on the time it stays in the colon, it is a rapid and reliable indicator of colonic transit time. Stool type will be determined according to the data obtained from the scale.
Measured: two weeks
Patient Global Impression of Improvement Scale
Individuals' perception of improvement in constipation complaints at the end of treatment will be questioned with the "Patient Global Impression of Improvement Scale" as follows. "How would you describe your current condition in terms of constipation compared to your condition at the beginning of treatment?" The available answers to this question are "Much better (1)", "Better (2)", "Somewhat better (3)", "No change (4)", "Somewhat worse (5)", "Worse (6)" and "Much worse (7)". Individuals will be asked to mark the answer that best describes their condition among the available answers.
Measured: two weeks
Visual Analog Scale (VAS)
After the treatment, the physical activity, nutrition (fiber and fluid intake) recommendations and compliance with the recommendations given regarding defecation position will be evaluated with the "Visual Analog Scale (VAS)". Individuals will be asked to mark the point that best describes them on a horizontal line with a real length of 10 cm. The distance of the marked point to the "0" point will be measured with a ruler and recorded in cm. On this scale, the "0" point will be defined as "I did not comply at all (%0)" and the "10" point will be defined as "I showed complete compliance (%100)".
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start25 May 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Two groups with a control group (recommendation) and exercise group (recommendation+Spinal stabilization exercise training)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Beste BÜLBÜL, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941103
- Sponsor's protocol ID
- Spinal Stabilization Exercise
- Acronym
- Exercise
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 23 Apr 2025
- 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spinal Stabilization Exercise Training in Women With Chronic Constipation
- ClinicalTrials.gov ID
- NCT06941103
- Acronym / sponsor ID
- Exercise / Spinal Stabilization Exercise
- Conditions
- Constipation
- Keywords
- spinal stabilization exercise, quality of life, spinal stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon MerkeziUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 23 Apr 2025 (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.
This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery, and spinal stability in women with chronic constipation.
Detailed description
This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery and spinal stability in women with chronic constipation. Individuals' physical, demographic, lifestyle, medical characteristics and medications used will be questioned and recorded. Physical activity level will be questioned with the "International Physical Activity Questionnaire-Short Form (IPAQ-SF)". In addition, constipation severity will be evaluated before and after treatment with the "Constipation Severity Scale (CSS)", functional markers of the intestine "Stool Diary and Bristol Stool Scale", the effect of constipation on the quality of life "The Patient Assessment of Constipation Quality of Life (PAC-QOL)", spinal stability "Sahrmann Test" and trunk muscle endurance "McGill Core Endurance Tests". In addition, perception of recovery will be evaluated after treatment with the "Patient Global Impression of Improvement Scale" and compliance with the recommendation will be evaluated with the "Visual Analog Scale (VAS)". The control group will be given only suggestions, while the exercise group will be given suggestions and spinal stabilization exercise training. Within the scope of the recommendation, you will first be informed about the definition of constipation, risk factors, treatment methods, and recommendations on physical activity, nutrition (fiber and fluid intake) and defecation position will be given to reduce constipation complaints. A brochure will be prepared to be distributed to individuals regarding these issues. Spinal stabilization exercise training will be applied 3 days a week for 8 weeks under the supervision of a specialist physiotherapist. Exercises consist of a 5-10 minute warm-up period, 40 minutes spinal stabilization exercise training a 5-10 minute cool-down period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a control group (recommendation) and exercise group (recommendation+Spinal stabilization exercise training)
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Spinal stabilization exercise training and recommendation, Other: RecommendationSpinal stabilization exercise training and recommendation |
| Control group | Other | Other: RecommendationRecommendation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with chronic functional constipation according to Rome 4 diagnostic criteria
- Those between the ages of 18-65
- Women who volunteer to participate in the study will be included.
Key exclusion criteria (10 listed)
- Those who are pregnant or breastfeeding
- Neurological diseases (Parkinson, Multiple Sclerosis, hemiplegia, etc.)
- Undercontrolled systemic/metabolic diseases (hypothyroidism, diabetes mellitus, hypokalemia, hypercalcemia, hypomagnesemia, etc.)
- Malignant diseases
- Accompanying colon or gastrointestinal problems (gastrointestinal bleeding, acute inflammation, etc.)
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 |
|---|---|---|
| Spinal stabilization exercise training and recommendationSpinal stabilization exercise training will be applied 3 days a week for 8 weeks under the supervision of a specialist physiotherapist. Exercises consist of a 5-10 minute warm-up period, 40 minutes SSET and a 5-10 minute cool-down period. Within the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues. | Other | Exercise group |
| RecommendationWithin the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues. | Other | Control group, Exercise group |
Primary outcome
Constipation Severity Scale (CSI)
Time frame: two weeks
Scale Varma et al. it was developed by to determine individuals' defecation frequency, intensity and difficulty experienced during defecation. Kaya et al. Turkish validity and reliability were conducted by . The scale consists of 16 questions and three sub-areas. These areas are 1. Fecal Obstruction, 2. Large Intestinal Laziness and 3. Pain. The lowest total score that can be obtained from the scale is 0 and the highest is 73. A high score indicates that the symptoms are serious.
5 secondary outcomes
Spinal Stability Assessment
Time frame: two weeks
Patient Assessment Constipation-Quality of Life Scale (PAC-QOL)
Time frame: two weeks
Bowel diary
Time frame: two weeks
Patient Global Impression of Improvement Scale
Time frame: two weeks
Visual Analog Scale (VAS)
Time frame: two 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 23 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal stabilization exercise training and recommendation and Recommendation in people with Constipation, run by Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi 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 10 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 23 Apr 2025. 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 Saliha Beste Bülbül, Master of Science (+90 5075798377, beste06bulbul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Severity Scale (CSI) (time frame: two weeks). 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 23 Apr 2025.