Kegel Exercise-focused Interventions in Elderly Women
24 de outubro de 2020 atualizado por: Hilal Gamze Hakbilen, Akdeniz University
The Effect of Kegel Exercise-focused Interventions on Urinary Incontinence in Elderly Women
Purpose: This study was conducted to investigate the effects of Kegel exercises-focused intervention undergone by elderly women diagnosed with urinary incontinence on their incontinence, quality of life and perceived impact level.
Design: The study has a single-blind randomized controlled experimental research design.
Methods: The study was carried out between December 2017 and March 2019 with 60 elderly women registered at the Home Health Unit of a Metropolitan Municipality in Turkey. The women were assigned to the intervention (n=30) and control (n=30) groups. The participants in the intervention group were paid home visits to provide them with individual training and counseling on Kegel exercises. Whether the participants did the exercises was followed up by weekly phone calls. The frequency of urinary incontinence, the amount of urine leaking and the quality of life of the participants and their complaints about incontinence were assessed with the International Consultation on Incontinence Questionnaire Short Form and questions on the assessment of the perceived impact at the onset of the study (0th week), and at home visits paid at the 6th and 12th weeks after the intervention.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Muratpaşa
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Antalya, Muratpaşa, Peru, 07310
- Home Health Unit of Antalya Metropolitan Municipality
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Over the age of 65,
- Being women,
- Diagnosed with UI,
- Being literate,
- Being able to communicate in Turkish,
- Standardized Mini Mental Test result was > 24,
- Agree to participate in research.
Exclusion Criteria:
- Who had received training on incontinence and Kegel exercises in the last 1 year,
- Had symptoms of urinary tract infection were identified,
- Being treated for UI,
- Having health problems affecting the muscle and nervous system,
- Being not able to perform daily life activities,
- Having pelvic organ prolapse,
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
The arm where the Kegel exercise focused intervention is applied
|
After the patients in the intervention group were interviewed on the telephone, the second home visit.
During this visit, the patients were trained on Kegel exercises and they were administered the ICIQ-SF.
Six weeks after the second visit, the third home visit was paid to determine whether the patients did the Kegel exercises and whether they did them accurately, to assess the perceived impact and to re-administer the ICIQ-SF.
After the 2nd and 3rd visit, the patients were called once a week for 6 weeks to monitor if they kept up with doing the Kegel exercises as they were taught.
Six weeks later, the 4th home visit were paid to the patients.
During this visit, whether the patients did the Kegel exercises and whether they did them accurately was determined, the perceived impact was assessed and the ICIQ-SF was re-administered.
|
|
Experimental: Control
The arm where home follow-up and scale evaluations are made
|
After the 1st visit, the patients included in the control group were called by phone and the 2nd home visit was planned.
During the second home visit, the ICIQ-SF was administered to them.
At the 3rd home visit paid 6 weeks after the 2nd visit, the ICIQ-SF was re-administered to the patients and the perceived impact assessment was performed.
During the 4th home visit paid 6 weeks after the 3rd home visit, the ICIQ-SF was re-administered to the patients, assessment of the perceived impact was performed, and finally they were given training on Kegel exercises.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in frequency of urinary incontinence after onset
Prazo: 6. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
6. week
|
|
Change in frequency of urinary incontinence after onset
Prazo: 12. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
12. week
|
|
Change in amount of urinary incontinence after onset
Prazo: 6. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
6. week
|
|
Change in amount of urinary incontinence after onset
Prazo: 12. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
12. week
|
|
Change in effects of urinary incontinence on daily life after onset
Prazo: 6. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
6. week
|
|
Change in effects of urinary incontinence on daily life after onset
Prazo: 12. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
12. week
|
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Change in assessment of the perceived impact after onset
Prazo: 6. week
|
Patient Information Form developed by the researchers based on the pertinent literature consists of 5 parts and 28 questions.
The first part questions the patient's age, height, weight etc.
The second part is on the patient's obstetric characteristics.
The third part questions the patient's health history.
The fourth part questions the patient's incontinence status.
The fifth part is on the assessment of the perceived impact.
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6. week
|
|
Change in assessment of the perceived impact after onset
Prazo: 12. week
|
Patient Information Form developed by the researchers based on the pertinent literature consists of 5 parts and 28 questions.
The first part questions the patient's age, height, weight etc.
The second part is on the patient's obstetric characteristics.
The third part questions the patient's health history.
The fourth part questions the patient's incontinence status.
The fifth part is on the assessment of the perceived impact.
|
12. week
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Evaluation of the participants in terms of performing Kegel Exercises
Prazo: 6. week
|
The Weekly Exercise Follow-up Form was developed by the researchers to assess the frequency of exercises in patients who were given Kegel exercise training.
The Weekly Exercise Follow-up Form has a timetable consisting of 7 days of the week and 3 parts of the day (morning, noon and evening).
The patients mark the timetable by placing an "X" on the blank corresponding to the time when they perform the exercise.
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6. week
|
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Evaluation of the participants in terms of performing Kegel Exercises
Prazo: 12. week
|
The Weekly Exercise Follow-up Form was developed by the researchers to assess the frequency of exercises in patients who were given Kegel exercise training.
The Weekly Exercise Follow-up Form has a timetable consisting of 7 days of the week and 3 parts of the day (morning, noon and evening).
The patients mark the timetable by placing an "X" on the blank corresponding to the time when they perform the exercise.
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12. week
|
|
Assesment of which cases do you leak urine?
Prazo: 6. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
6. week
|
|
Assesment of which cases do you leak urine?
Prazo: 12. week
|
The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence.
The first three sub-dimensions are included in scoring.
The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints.
The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively.
While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
|
12. week
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de dezembro de 2017
Conclusão Primária (Real)
17 de março de 2019
Conclusão do estudo (Real)
28 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
21 de outubro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de outubro de 2020
Primeira postagem (Real)
29 de outubro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Akdeniz Uni
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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