NCT06621160

Brief Summary

The aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

September 25, 2024

Last Update Submit

September 30, 2024

Conditions

Keywords

Chronic ConstipationPostureAnthropometric MeasurementPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 year

Study Arms (2)

Control group

The control group consists of healthy women.

Other: Observation

CC Group

The CC group consists of women with chronic constipation.

Other: Observation

Interventions

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.

CC GroupControl group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women with and without chronic constipation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant İzzet Baysal University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 1, 2024

Study Start

March 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations