Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT03106857
Eligibility Criteria:
Inclusion Criteria:
Patients whose BMI exceeded 30 kg/m2 were included.
In addition, they fulfilled the ROM criteria of constipation, as follows:
1. Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis:
1. straining during at least 25% of defecations,
2. lumpy or hard stools in at least 25% of defecations,
3. sensation of incomplete evacuation for at least 25% of defecations,
4. sensation of anorectal obstruction/blockage for at least 25% of defecations,
5. requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and
6. fewer than 3 defecations per week;
2. Loose stools rarely occurred without the use of laxatives;
3. Insufficient criteria for irritable bowel syndrome; and
4. Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Exclusion Criteria:
* Patients with metabolic, endocrine, and neurologic constipation;
* current or past smokers;
* those with any orthopedic limitation; and
* those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study.
Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03106857
Study Brief:
Protocol Section:
NCT03106857