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Набор скоро начнётся NCT07094347

Effects of Intradialytic Inspiratory Muscle Training on Functional Capacity in Hemodialysis Patients

Без фазы С лечением Hemodialysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: inspiratory muscle training.
Кому может быть актуально
Состояния в реестре: Hemodialysis. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

There is a need for long-term sustainable studies that will increase the potential health benefits in hemodialysis patients. Inspiratory muscle training, one of the recommended treatments to increase exercise capacity and quality of life during dialysis treatment in people with chronic renal failure, is a method that can be applied intradialytically, in addition to being easy to apply, cheap and sustainable. It improves functional capacity by increasing respiratory muscle strength. In this context, our study aims to investigate the effects of inspiratory muscle training on functional parameters and on hemodialysis patients with a personalized portable device and to add it to the literature.

Подробное описание

Chronic kidney disease is defined as abnormalities in kidney structure or function that have been present for more than three months and will adversely affect health. Two markers used to define chronic kidney disease, which is characterized by progressive loss of kidney mass and function, are glomerular filtration rate (GFR) and albumin-creatinine ratio. Chronic kidney disease can be divided into five stages according to GFR, and the most severe end-stage chronic kidney disease is also defined as chronic renal failure and requires renal replacement therapy to maintain homeostasis. The most commonly applied method of renal replacement in our country is hemodialysis.

It is known that muscle atrophy, where muscle regeneration and repair capacity decrease, is frequently seen in chronic kidney disease patients. Although it is partly due to aging, muscle atrophy is frequently seen due to the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and lack of physical activity; increased muscle loss also increases the risk of morbidity, mortality and end-stage renal disease in patients.

Studies have shown that there is a decrease in respiratory muscle strength as well as skeletal muscle strength in chronic kidney disease patients. Decreased respiratory muscle strength causes individuals to have low cardiorespiratory fitness, and chronic kidney disease patients face limitations in daily life activities and increased mortality.

Pulmonary system involvement and decreased exercise tolerance are among the important causes of functional capacity and disease-related complications in chronic kidney disease patients. Inspiratory muscle strength is related to functional capacity in hemodialysis patients. In the literature, it is shown that inspiratory muscle training improves functional parameters and modulates inflammatory biomarkers, as in aerobic and combined exercise training. Inspiratory muscle training is a useful method to increase peripheral and inspiratory muscle strength, respiratory function, quality of life and balance, and to reduce dyspnea and fatigue in patients with chronic kidney disease.

Exercises performed during dialysis are called intradialytic exercises. It does not require extra time to exercise; The advantages of this exercise protocol include the fact that patients can be monitored by healthcare professionals during exercise and that any complications can be detected and treated immediately, and that intradialytic exercise increases blood flow to the muscles and increases solute removal. Inspiratory muscle training, one of the recommended treatments to increase exercise capacity and quality of life during dialysis treatment in people with chronic renal failure, is a method that can be applied intradialytically, in addition to being easy to apply, cheap and sustainable. It improves functional capacity by increasing respiratory muscle strength. It is stated that inspiratory muscle training protocols applied in the range of 30-60% of the individual's maximum inspiratory pressure improve respiratory muscle strength, functional capacity and quality of life in patients with chronic renal failure. However, the number of studies showing the effects of this type of training applied at different intensities in dialysis patients is quite low. In addition, the effects of intradialytic inspiratory muscle training applications have not yet been shown. There is a need for long-term sustainable studies in the literature that will increase the potential health benefits in hemodialysis patients. In this context, our study aims to investigate the effects of inspiratory muscle training on functional parameters and its contribution to the literature with a personalized portable device in hemodialysis patients.

Вмешательства

  • Устройство inspiratory muscle training
    Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

Первичные конечные точки

  • Inspiratory muscle strength [Срок оценки: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).]
Вторичные конечные точки (1)
  • Exercise Capacity Assessment [Срок оценки: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).]

Критерии участия

Критерии включения

  • Being on hemodialysis for at least 6 months
  • Being on hemodialysis for 4 hours, 3 days a week
  • Not having had a transplant
  • Being able to continue sitting and standing
  • Being able to walk without assistance
  • Being willing to participate in the study

Критерии исключения

  • Individuals with communication and/or cognitive problems that are unable to fulfill the assessment and treatment requirements
  • Patients with uncontrolled cardiac, pulmonary or other systemic diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Katayifci N, Huzmeli I, Iri S D, Turgut FH. Effects of different inspiratory muscle training protocols on functional exercise capacity and respiratory and peripheral muscle strength in patients with chronic kidney disease: a randomized study. BMC Nephrol. 2024 May 29;25(1):184. doi: 10.1186/s12882-024-03610-1. PMID 38811888

Идентификаторы

NCT: NCT07094347 · KA24/416

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗