The Efficacy of Therapeutic Exercises Delivered by Smartphone Application

Sponsor
Jordan University of Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05347472
Collaborator
(none)
60
1
2
14
4.3

Study Details

Study Description

Brief Summary

Therapeutic exercise has been shown to be effective in Urinary Incontinence management. However, there is a lack of physiotherapy services provided such necessary treatment. Moreover, mobile applications are becoming popular, and there are limited applications designed to help women with Urinary Incontinence. Consequently, no study investigated the effect of a smartphone application with specific exercises program for Urinary Incontinence management. Therefore, the aim of this study is to determine the effect of a Urinary Incontinence exercises delivered by smartphone application on UI outcomes.

Condition or Disease Intervention/Treatment Phase
  • Other: Smartphone application
  • Other: Sham Smartphone application
N/A

Detailed Description

Urinary incontinence (UI) is a common health disorder among women in Jordan and worldwide. UI affects women's quality of life, mental health symptoms, and social participation. However, limited numbers of women with UI seek help for their problems for many reasons, including lack of rehabilitation services, feelings of shame, and unwillingness to discuss their problems. Therapeutic exercise has been shown to be effective in UI management. However, there is a lack of physiotherapy services provided such necessary treatment. Moreover, mobile applications are becoming popular, and there are limited applications designed to help women with UI. Consequently, no study investigated the effect of a smartphone application with specific exercises program for UI management. Therefore, the aim of the study is to develop an evidence-based therapeutic exercise application for UI and investigate its efficacy on UI clinical outcomes. We hypothesize that patients in the intervention group will have a significantly lower score of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) , a lower score of perceived stress scale, lower Depression Anxiety and Stress scale (DASS-21) score, a higher score of Multidimensional Scale of Perceived Social Support (MSPSS), a higher Short Form Health Survey (SF-12) score, and a higher score of Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) in comparison to the control group.

A randomized controlled trial design. Sixty women with urinary incontinence will be included in this study. Participants will be randomized to the intervention group who will receive the mobile application (will include general information about UI and exercises) and the intervention group who will receive the sham application (include information about UI only). Outcome measures will include Arabic ICIQ-UI SF to assess the frequency of urinary incontinence, the Arabic version of MSPSS to assess the social support, the Arabic version of (DASS-21) to assess the mental health symptoms, SF-12 to assess the quality of life, and ICIQ-LUTSqol to assess the quality of life of women with UI.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Efficacy of Therapeutic Exercises Delivered by Smartphone Application for Urinary Incontinence Among Women: a Randomized Controlled Trial
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

In this group, women will receive the smartphone application intervention that will include daily physical therapy exercises program

Other: Smartphone application
the smartphone application intervention will consist daily physical therapy exercises program. The application will include all the videos about the exercises and all information about the repetition, frequency, intensity, and position.

Placebo Comparator: Control group

In this group, women will receive the sham application that includes information and general advice about UI only

Other: Sham Smartphone application
ham application that includes information and general advice about UI only

Outcome Measures

Primary Outcome Measures

  1. International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). [Change from baseline to 4 weeks and 16 weeks]

    The questionnaire assesses the quality of life of women with UI.

  2. Arabic International Consultation on Incontinence Questionnaire-Urinary [Change from baseline to 4 weeks and 16 weeks]

    Provides measurement of severity of UI and its impact on daily life

  3. Arabic version of Multidimensional Scale of Perceived Social [Change from baseline to 4 weeks and 16 weeks]

    Self-report measure of subjectively assessed social support

Secondary Outcome Measures

  1. Short Form Health Survey [Change from baseline to 4 weeks and 16 weeks]

    Measures a person's health-related quality of life

  2. Depression Anxiety Stress Scales [Change from baseline to 4 weeks and 16 weeks]

    Measure the emotional state of depression, anxiety, and stress

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients diagnosed with UI, aged between 18-40, ability to read and own and use smartphone applications
Exclusion Criteria:
  • Women with no medical diagnosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Abdullah University Hospital Irbid Jordan 22110

Sponsors and Collaborators

  • Jordan University of Science and Technology

Investigators

  • Principal Investigator: Saddam F Kanaan, PhD, Jordan University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saddam Kanaan, Associate Professor, Jordan University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05347472
Other Study ID Numbers:
  • 20210408
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Apr 26, 2022