The Effect of Incontinence Program Applied to Obese Elderly on Quality of Life, Coping and Loneliness

NCT ID: NCT05892575

Last Updated: 2023-06-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this: It was planned in a single-blind randomized controlled pre-test-post-test experimental research design. The aim of this study is to determine the effect of urinary incontinence management program on quality of life, coping with incontinence and loneliness in obese elderly.

The main questions it aims to answer are:

Does the Urinary Incontinence Management Program prepared for the obese elderly affect the quality of life, coping with incontinence and loneliness levels of the elderly in the experimental and control groups? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the level of coping with incontinence of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there a decrease in the loneliness levels of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life, coping with incontinence and loneliness levels of the elderly in the experimental group after the intervention compared to the pre-intervention?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Worldwide, there is a transition from a young population structure to an aging population structure, and life expectancy at birth is increasing. As the global growth of the elderly population will continue, we are moving towards an aging world.

According to the World Health Organization, it is estimated that the population aged 60 and over will reach 2 billion by 2050. With increasing age, changes occur in every system in the body. One of these systems is the urinary system.

UI suggests that it may be an early marker of the onset of frailty. In the elderly; UI is expressed as the 4th most disturbing disease after angina, difficulty in ambulation and psychiatric disorders. Among the UI subtypes, stress urinary incontinence and urge urinary incontinence are the most common and urge urinary incontinence is seen especially in the elderly.

UI occurs as a result of deterioration in pelvic floor structure functions.Obesity is the best known and potentially the most modifiable risk factor for the development of UI, leading to pelvic floor deficiencies. There is a strong and positive relationship between obesity and urinary incontinence.

Compared with patients of normal weight, obese patients are approximately twice as likely to present with urinary incontinence.

Individuals may experience physical and psychosocial limitations due to UI, and their quality of life may be adversely affected. As a result of this situation, anxiety, depression, deterioration in sexual life, decrease in physical activity, loss of self-confidence and social isolation problems can be seen. All these conditions are in themselves associated with poor quality of life.

Urinary incontinence is rarely reported, especially in older adults, as it is believed to be a natural consequence of aging and that there is no clear management approach or cure. Therefore, individuals with UI do not seek help from family members or healthcare providers for urinary incontinence symptoms for various reasons. However, despite experiencing urinary incontinence, people may not seek treatment for reasons such as ignorance, ignorance, not being able to find time to go to the doctor, thinking about urinary incontinence as normal, or rejecting or hiding incontinence. Individuals with urinary incontinence do not seek help and try to cope with this problem on their own.

UI that negatively affects psychological and social well-being and quality of life; Decreased self-confidence of the individual brings along problems such as living alone and escaping from society. Individuals sometimes reduce or avoid social contacts and activities to control UI. This leads to increased social isolation and feelings of loneliness.

It is stated that conservative treatment methods can be used in the first-line treatment of urinary incontinence. In the guidelines of the European Association of Urology, it is emphasized that conservative treatment methods of urinary incontinence should be used as the first choice in the treatment of patients. Conservative treatment methods include lifestyle changes (weight loss, smoking cessation, diet regulation, regulation of fluid consumption), behavioral treatments, and pelvic floor muscle training. Among these methods, pelvic floor muscle exercises come to the fore. In the treatment of urinary incontinence of the frail elderly, pelvic floor exercises are included in the first-line treatment.

Incontinence is also related to nutrition. Nutrition can affect lower urinary system functions. In order to prevent or reduce UI, the European Urology Association 2020 guideline states that different lifestyle practices, such as reducing caffeinated beverages, regulating fluid intake, and quitting smoking, together with weight loss, have an effect on UI symptoms.

Some exercises can reduce urinary incontinence symptoms. Characterized by a gentle/gentle, slow and coordinated sequence of movements, Tai-Chi exercise is a suitable form of exercise for older adults as it involves minimal strain on the joints and cardiovascular system. Tai chi exercise is an easy-to-learn and ubiquitous exercise recommended for both men and women in conditions related to the pelvic area and for improving health in the elderly. In one study, Tai Chi improved the quality of life of elderly women with overactive bladder syndrome, emergency urinary incontinence. In another study, it was found that men with lower urinary tract symptoms performed tai chi and a significant result was obtained compared to men without lower urinary tract symptoms.

Health-promoting measures for older adults with UI are necessary to maintain their well-being and prolong healthy life expectancy. It will be important to create a training component/plan for this. Considering learning principles in planned adult education activities can contribute to the formation of an effective learning environment for adults. Knowles brought a different and systematic perspective to the subject of adult learning. In this context, training components can be prepared according to Knowles' adult learning principles.

It is recommended to use some models and theories, especially behavior modification theories, for those with incontinence problems to acquire healthy lifestyle behaviors. Health Belief Model (SIM) is one of the best models that can be used to develop knowledge, attitudes, beliefs about urinary incontinence and to create behavior towards kegel exercise, which is one of the effective methods in preventing urinary incontinence.

Studies for the prevention of urinary incontinence are limited in the literature, and interventional studies based on a theoretical background have not been found. In this study, the Incontinence Management Program based on Knowles' Adult Learning Principles and Health Belief Model will be used.

According to Knowles' Adult Learning Principles, which gives a different and systematic perspective to adult learning, no national or international study on obese elderly people has been found in the literature. At the same time, although SIM is used for more than one disease and various studies have been conducted, no study has been found to strengthen the motivation to change behavior in order to ensure continuity for obese elderly people. In addition, no study has been found in the literature in which the effectiveness of an education in which lifestyle behaviors based on Knowles' Adult Learning Principles and Health Belief Model, Kegel exercises and Tai Chi exercises are applied in the management of UI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Primary Incontinence, Urge Incontinence Stress Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental:educt

Training on improving the quality of life, coping with incontinence and kegel exercises will be given to obese elderly people over 65 years of age with urinary incontinence in the experimental group.

Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.

Group Type EXPERIMENTAL

improving quality of life, coping with urinary incontinence and kegel exercise training

Intervention Type BEHAVIORAL

Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.

active comparator, control group

The elderly in the control group will not be interfered with.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

improving quality of life, coping with urinary incontinence and kegel exercise training

Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Standardized Mini Mental Test (SMMT) total score of 24 and above,
* 30 ≥ BMI ≥ 34.9 (obesity class 1) obese,
* 65 years and older,
* Those experiencing stress or urge urinary incontinence,
* Able to use smart mobile phone, use Whatsapp application,
* Those who do not have a health problem that prevents them from doing Kegel exercises.

* Those with a history of incontinence surgery,
* Those who are morbidly obese,
* Having neurological and psychiatric disease,
* with pelvic organ prolapse,
* Having a disease affecting the genital and urinary system,
* those who cannot be communication.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Şeyma SOYANIT ERASLAN

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

İlknur Aydın Avci, professor

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sinop Family Health Center No. 1

Sinop, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Şeyma Soyanıt Eraslan, research ast

Role: CONTACT

+90 0542 778 4771

İlknur Aydın Avci, professor

Role: CONTACT

+90 05052031286

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

şeyma soyanıt eraslan

Role: primary

05427784771

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5962309/

The impact of pelvic floor muscle training on the quality of life of women with urinary incontinence: a systematic literature review

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OndokuzMay

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Physical Fitness in Elderly
NCT04250870 COMPLETED NA