- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621160
Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey
- Abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria for women with chronic constipation:
- Constipation according to Rome IV criteria between the ages of 18-65
- Volunteer
- Literacy
Inclusion criteria for healthy women:
- No constipation according to Rome IV criteria between the ages of 18-65
- Volunteer
- Literacy
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Control group
The control group consists of healthy women.
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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.
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CC Group
The CC group consists of women with chronic constipation.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anthropometric Characteristics
Time Frame: 1 year
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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 |
1 year
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Spinal Posture
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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