The Efficacy of Therapeutic Exercises Delivered by Smartphone Application

NCT ID: NCT05347472

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Smartphone application

Intervention Type OTHER

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.

Control group

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

Group Type PLACEBO_COMPARATOR

Sham Smartphone application

Intervention Type OTHER

ham application that includes information and general advice about UI only

Interventions

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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.

Intervention Type OTHER

Sham Smartphone application

ham application that includes information and general advice about UI only

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Saddam Kanaan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saddam F Kanaan, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

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King Abdullah University Hospital

Irbid, Irbid Governorate, Jordan

Site Status

Countries

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Jordan

Other Identifiers

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20210408

Identifier Type: -

Identifier Source: org_study_id

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