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临床试验/NCT06200922
NCT06200922进行中(未招募)不适用

Telehealth in the Rehabilitation of Urinary Incontinence in Older Women: Randomized Controlled Trial

Federal University of Health Science of Porto Alegre2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
69
试验地点
2
主要终点
Type of Urinary Incontinence.

研究概览

简要总结

The goal of this randomized clinical trial is to compare the effectiveness of a pelvic floor rehabilitation program in a face-to-face versus remote in community-dwelling elderly women with urinary incontinence. The main question it aims to answer is: What is the difference in effectiveness of a pelvic floor rehabilitation program through face-to-face versus remote intervention? Participants will be divided into three groups: Synchronous Group: will receive guidance and perform a real-time guided pelvic physiotherapy protocol through online physiotherapy by the physiotherapist, Asynchronous Group: will receive guidance and perform a pelvic physiotherapy protocol after the evaluation, without the real-time monitoring by the physical therapist and face-to-face group: will receive guidelines and will perform a pelvic physiotherapy protocol oriented in person by the physical therapist. All groups will receive the same treatment for 12 weeks, which will include floor muscle training pelvic floor, urge suppression techniques, bladder training and behavioral therapy. Participants will be evaluated pre-treatment, at the end of the 6th week, and at the end of 12 weeks.

详细描述

Aging is associated with changes in body composition, including a decrease in skeletal muscle mass. As a result, approximately 30-40% of the elderly may experience urinary incontinence, considered one of the most important geriatric syndromes, associated with a negative impact on quality of life. In clinical practice, pelvic floor muscle training and behavioral therapy promote positive effects on pelvic floor rehabilitation when performed and guided through face-to-face consultations. Through Telehealth, the aspects that refer to the role of the physiotherapist, technologies used and format of the approach do not seem to be clarified. Virtual home care is an accepted reality because it improves access to health care and has a positive effect on outcomes. However, barriers to its use can affect the accessibility. According to the World Health Organization, the definition of telehealth is "the provision of health services, where distance is a critical factor, by all health professionals, using information and communication technologies to exchange valid information for diagnosis, treatment and prevention of disease and injury, research and evaluation, and for the continuing education of health professionals, all in the interest of promoting the health of individuals and their communities". The World Confederation for Physical Therapy defines digital practice, "a term used to describe health services, support, and information provided remotely through digital communication and devices." The main objective is "to facilitate the effective delivery of Physical Therapy services, improving access to care and information, and managing health resources". In Brazil, the Federal Council of Physiotherapy and Occupational Therapy published the resolution for the practice of telehealth in a pandemic period, teleconsultation, telemonitoring and teleconsultation. Our hypothesis is that the synchronous and asynchronous communication between the physiotherapist and the participants, with or without the help of caregivers, may enable adherence to the home rehabilitation process when compared to face-to-face treatment, minimizing the effects of urinary incontinence. This study proposes to contribute to knowledge in the field of Pelvic Physiotherapy, in particular, through telehealth to provide the service of rehabilitation for elderly women with pelvic floor disorders, using the advancement of technology as a facilitator of synchronous and asynchronous communication, to approach elderly urinary incontinence and still compare the two forms of rehabilitation through telehealth with the face-to-face treatment. It is widely known that urinary incontinence is a factor of social inhibition for causing embarrassment, in addition to producing disturbance in the sleep in the face of increased nocturnal voiding frequency, directly affecting the quality of life of the elderly. The proposed safe and guided by a physiotherapist through three rehabilitation programs, synchronous telerehabilitation (in real time), asynchronous telerehabilitation (without real-time contact) and face-to-face rehabilitation, can be used to provide interventions in order to optimize health-related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The evaluations will be performed by a different researcher.

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 60 years old or more;
  • Urinary Incontinence for at least 12 months
  • Internet access.

排除标准

  • Pelvic cancer;
  • Sling surgery;
  • Urinary catheter;
  • Antimuscarinic medication;
  • Alzheimer;
  • Parkinson;
  • Multiple Sclerosis;
  • Uncontrolled diabetes.

结局指标

主要结局

Type of Urinary Incontinence.

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Type of UI by self-report question: What kind of Has leakage occurred more frequently in the last 7 days?

Presence of Urinary Incontinence.

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Application of The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

Frequency of Urinary Incontinence

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Self-reported frequency of leakage

Frequency of Urinary Incontinence.

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Self-reported use of pads.

Overactive bladder symptoms.

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Application of The International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ OAB)

Quality of Life.

时间窗: Pre-treatment, at the end of the 6th week, at the end of 12 weeks.

Application of The International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol).

次要结局

  • Patient's Satisfaction.(At the end of 12 weeks.)
  • Adherence to the study.(At the end of the 6th week and at the end of 12 weeks.)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Henrique Telles da Rosa

Clinical Professor

Federal University of Health Science of Porto Alegre

研究点 (2)

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