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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06045728
Other study ID # P.T.REC/012/004621
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date December 30, 2023

Study information

Verified date September 2023
Source Cairo University
Contact salma I alghitany, PHD
Phone 01229723881
Email fardreams@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.


Description:

overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 30, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 45 Years
Eligibility Inclusion Criteria: - women aged 35-45 years old - class I obesity(30-34.9kg/m2) - women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire - waist circumference more than 88 cm Exclusion Criteria: - history of surgical treatment of urological disease - infection of urinary tract - oncological and neurological urinary tract disease, - refusal to participate in the study

Study Design


Intervention

Other:
Pilates exercises
Pilates is a group of low impact muscle exercises that strengthen abdominal muscles, back, hips and pelvic floor muscles. the exercise consists of 10 min warm up, 40 min exercise and 10 min cooling down. the exercises that will be included: spine twist, double leg stretch, double leg circles, side leg circle, curl up, shoulder bridges and pelvic curl.
Behavioral:
Mediterranean diet
it is a type of diet used for obesity management based on high vegetable intake, olive oil as a source of fat, the consumption of grains, legumes, and nuts with high amounts of pulp, low-medium consumption of fish, low consumption of red meat.

Locations

Country Name City State
Egypt Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital) Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary body mass index it is calculated by dividing weight in kg on height in m square at baseline and after 12 weeks of the intervention
Primary waist circumference it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females at baseline and after 12 weeks of the intervention
Primary overactive bladder questionnaire short form is a questionnaire that is divided into two sections : symptoms and quality of life. In symptoms section, the higher the scores the more the symptoms that bother the patients. higher scores in quality of life section indicates better quality of life. at baseline and after 12 weeks of the intervention
Primary patient perception of intensity of urgency scale a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency at baseline and after 12 weeks of the intervention
Primary HOMA IR The homeostatic model assessment (HOMA IR) is a method used to quantify insulin resistance . derived from the product of the insulin and glucose values divided by a constant. at baseline and after 12 weeks of the intervention
Secondary telehealth usability questionnaire a comprehensive questionnaire that covers all usability factors (i.e., usefulness, ease of use, effectiveness, reliability, and satisfaction). It is used with various types of telehealth systems, including the traditional videoconferencing systems, computer-based systems, and the mobile telehealth systems. after 12 weeks of the intervention
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