Telerehabilitation for Overactive Bladder Syndrome in Obese Women

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06045728
Collaborator
(none)
80
1
2
3.5
23

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates exercises
  • Behavioral: Mediterranean diet
N/A

Detailed 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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
For insulin resistance the investigator will not know which group will be assessed
Primary Purpose:
Treatment
Official Title:
Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group 1 telerehabilitation group

subjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks

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.

Other: group 2 control group

subjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks

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.

Outcome Measures

Primary Outcome Measures

  1. body mass index [at baseline and after 12 weeks of the intervention]

    it is calculated by dividing weight in kg on height in m square

  2. waist circumference [at baseline and after 12 weeks of the intervention]

    it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females

  3. overactive bladder questionnaire short form [at baseline and after 12 weeks of the intervention]

    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.

  4. patient perception of intensity of urgency scale [at baseline and after 12 weeks of the intervention]

    a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency

  5. HOMA IR [at baseline and after 12 weeks of the intervention]

    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.

Secondary Outcome Measures

  1. telehealth usability questionnaire [after 12 weeks of the intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital) Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: salma I alghitany, PHD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Salma Ibrahim Abdelmohsen Alghitany, teacher at Faculty of physical therapy Cairo university, Cairo University
ClinicalTrials.gov Identifier:
NCT06045728
Other Study ID Numbers:
  • P.T.REC/012/004621
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023