The Effect of Aerobic Exercise on Lower Urinary System Symptoms in Women With Diabetes Mellitus

NCT ID: NCT06249399

Last Updated: 2024-03-05

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-03-01

Brief Summary

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The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method.

The main questions it aims to answer are:

* Is aerobic exercise effective on bladder functions in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
* Is aerobic exercise effective on urinary tract symptoms in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
* Is aerobic exercise effective on quality of life in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?

Intervention/treatment

* Control group individuals will be given a behavioral treatment program.
* Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.

Detailed Description

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The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method. Bladder sensation (first sensation) and compliance from urodynamic evaluations will be taken as reference as the primary outcome measurement in treatment effectiveness.

* Control group individuals will be given a behavioral treatment program.
* Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.

AE training was provided three days a week, 45 minutes a day, for 12 weeks. The behavioral treatment protocol was completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Conditions

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Lower Urinary Tract Symptoms Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: aerobic exercise group and control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise Group

A behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

Aerobic Exercise training will be provided three days a week, 45 minutes a day, for 12 weeks. Patients will be subjected to submaximal aerobic exercise with rhythmic movements without equipment via video conference accompanied by a physiotherapist.

Behavioral Treatment Program

Intervention Type BEHAVIORAL

Behavioral Treatment Program will be completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Control group

A behavioral treatment program will be applied to the patients.

Group Type ACTIVE_COMPARATOR

Behavioral Treatment Program

Intervention Type BEHAVIORAL

Behavioral Treatment Program will be completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Interventions

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Aerobic Exercise

Aerobic Exercise training will be provided three days a week, 45 minutes a day, for 12 weeks. Patients will be subjected to submaximal aerobic exercise with rhythmic movements without equipment via video conference accompanied by a physiotherapist.

Intervention Type OTHER

Behavioral Treatment Program

Behavioral Treatment Program will be completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women between the ages of 35-55,
* Individuals who volunteer to participate in the study,
* Those diagnosed with Type II diabetes for 5 years or more and those diagnosed with LUTS

Exclusion Criteria

* Stage 2 and more advanced pelvic organ prolapse,
* Urinary tract infection,
* Has had previous surgery for urinary incontinence and pelvic organ prolapse,
* Diagnosis of Cerebro Vascular Event (CVE) and dementia,
* Using A-blockers, antimuscarinics, antidepressants, diuretics and antihistamines,
* Individuals in menopause.
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role collaborator

Hasan Kalyoncu University

OTHER

Sponsor Role collaborator

Gaziantep Islam Science and Technology University

OTHER

Sponsor Role lead

Responsible Party

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Bengisu Tüfekçi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bengisu TÜFEKÇİ

Role: PRINCIPAL_INVESTIGATOR

Hasan Kalyoncu University

Locations

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Hasan Kalyoncu University

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GİBTU-FP-BT-01

Identifier Type: -

Identifier Source: org_study_id

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