Chronic ConstipationNCT06621160
Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
An observational study of Chronic Constipation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Observation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with and without chronic constipation
Who may be able to join
- Constipation according to Rome IV criteria between the ages of 18-65
- Volunteer
- Literacy
- No constipation according to Rome IV criteria between the ages of 18-65
- Volunteer
- Literacy
Who cannot join
- Cancer, neurological disease, serious or uncontrolled systemic or metabolic disease
- Being pregnant
- Having a mental problem that will prevent cooperation
- Having alarm symptoms over the age of 50
- Having a diagnosis of secondary constipation
- Being BMI\>35
Show all 11Show fewer
- Having megacolon/megarectum and inactive (lazy) bowel syndrome
- Having had colostomy surgery
- Having a history of recent abdominal surgery
- Having an open wound or local tumor in the abdominal region
- Having an abdominal hernia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women.
- Conditions
- Chronic Constipation
- Being tested
- Observation
- Keywords
- Chronic Constipation, Posture, Anthropometric Measurement, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
After the participants\' physical and sociodemographic characteristics were recorded, they were asked to fill out the Constipation Severity Scale and 7- Day Stool Diary to determine their constipation levels. The individuals\' anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements, spinal postures were assessed with the Spinal Mouse, and physical activity levels were assessed with the International Physical Activity Questionnaire-Short Form UFAA-KF and pedometer.
| Study group | Role | What they receive |
|---|---|---|
| Control group | The control group consists of healthy women. Receives: Other: Observation | |
| CC Group | The CC group consists of women with chronic constipation. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Characteristics
The individuals anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements.
Triceps skinfold thickness, subscapula skinfold thickness, suprailiac skinfold thickness, calf skinfold thickness were measured with skinfold caliper; humeral epicondyle diameter, femoral epicondyle diameter were measured with mechanical caliper, biceps circumference, calf circumference were measured with tape measure. Skinfold thickness measurements were performed by the same person. The measurements were taken from the dominant side of the individuals. The measurements were performed on healthy skin and the areas to be measured were marked with a marker. The individuals were asked to relax their muscles while the measurement was performed. The skin in the marked areas was pulled up by pinching between the index finger and thumb, and the skinfold caliper was placed 1 cm below t
Measured: 1 year
Spinal Posture
The individuals spinal postures were assessed with the Spinal Mouse. Individuals were informed about the device used and the duration of the assessment. Before the measurement, the positions in which the assessment would be made and how to do these positions were explained to the individuals. Then, a trial measurement was made once. The individuals\' demographic information was entered into the computer software. Individuals were asked to stand symmetrically with their vertebral columns exposed, to take off their shoes and step onto the mat, and to distribute their weight equally on both feet on a flat surface. Spinal processes starting from C7 to S3 were determined by the physiotherapist and marked with a felt-tip pen. For measurements, the Spinal Mouse device was moved from C7 to the S3 spinous process.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Mar 2022
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Çakır, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621160
- Sponsor's protocol ID
- 16/2022
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
- ClinicalTrials.gov ID
- NCT06621160
- Acronym / sponsor ID
- 16/2022
- Conditions
- Chronic Constipation
- Keywords
- Chronic Constipation, Posture, Anthropometric Measurement, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Oct 2024 (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 aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: ObservationThe control group consists of healthy women. |
| CC Group | – | Other: ObservationThe CC group consists of women with chronic constipation. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with and without chronic constipation
Key inclusion criteria (6 listed)
Key exclusion criteria (11 listed)
- Cancer, neurological disease, serious or uncontrolled systemic or metabolic disease
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 |
|---|---|---|
| ObservationAfter the participants\' physical and sociodemographic characteristics were recorded, they were asked to fill out the Constipation Severity Scale and 7- Day Stool Diary to determine their constipation levels. The individuals\' anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements, spinal postures were assessed with the Spinal Mouse, and physical activity levels were assessed with the International Physical Activity Questionnaire-Short Form UFAA-KF and pedometer. | Other | CC Group, Control group |
Primary outcome
Anthropometric Characteristics
Time frame: 1 year
The individuals anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements. Triceps skinfold thickness, subscapula skinfold thickness, suprailiac skinfold thickness, calf skinfold thickness were measured with skinfold caliper; humeral epicondyle diameter, femoral epicondyle diameter were measured with mechanical caliper, biceps circumference, calf circumference were measured with tape measure. Skinfold thickness measurements were performed by the same person. The measurements were taken from the dominant side of the individuals. The measurements were performed on healthy skin and the areas to be measured were marked with a marker. The individuals were asked to relax their muscles while the measurement was performed. The skin in the marked areas was pulled up by pinching between the index finger and thumb, and the skinfold caliper was placed 1 cm below t
Spinal Posture
Time frame: 1 year
The individuals spinal postures were assessed with the Spinal Mouse. Individuals were informed about the device used and the duration of the assessment. Before the measurement, the positions in which the assessment would be made and how to do these positions were explained to the individuals. Then, a trial measurement was made once. The individuals\' demographic information was entered into the computer software. Individuals were asked to stand symmetrically with their vertebral columns exposed, to take off their shoes and step onto the mat, and to distribute their weight equally on both feet on a flat surface. Spinal processes starting from C7 to S3 were determined by the physiotherapist and marked with a felt-tip pen. For measurements, the Spinal Mouse device was moved from C7 to the S3 spinous process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Constipation, run by Ondokuz Mayıs University 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 1 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Characteristics (time frame: 1 year). 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 1 Oct 2024.