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Набор скоро начнётся NCT07555522

Gender-Based Differences In Dynamic Balance Among Hemodialysis Patients

Наблюдательное Hemodialysis Patient

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hemodialysis Patient. Базовые параметры: 20 лет — 60 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Aim of the study is to investigate gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients. The main question it aims to answer is: Are there gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients?

Подробное описание

Kidney disease is a prevalent renal disorder affecting a significant proportion of the global population, creating major challenges for health, quality of life and economic burden. Kidney disease is characterized by an irregularity in kidney structure or function that may manifest suddenly and can either resolve or progress to a chronic state. Chronic Kidney Disease (CKD) is a broad term for several illnesses characterized by varied clinical manifestations with kidney failure being the most severe consequence, demanding treatment only through dialysis or transplantation.

Hemodialysis is characterized by the diffusion of solutes via a semipermeable membrane, with the objective of restoring the homeostatic balance of intracellular and extracellular fluids, as typically regulated by healthy kidneys. Although hemodialysis is essential for life in patients with advanced CKD, it is associated with significant impairments in balance.

Several studies have consistently shown that individuals receiving hemodialysis suffer from balance control deficits. These include greater postural sway, diminished dynamic stability, and slow prolonged sit-to-stand performance, even in individuals who self-report satisfactory physical function.

Balance impairment in hemodialysis patients is attributed to proprioceptive sensory impairments, diminished lower-limb muscle strength, and neuromuscular dysfunction. Moreover, high-risk sarcopenia has been demonstrated to connect with compromised dynamic balance, evidenced by reduced gait speed, diminished stride length, extended double support phase, and elevated Timed-Up-and-Go (TUG) test durations.

Balance is typically classified into static balance and dynamic balance. Both are affected in active hemodialysis patients but impairment in dynamic balance is a more important predictor of accidental falls in these patients .

Falls are a major health concern among hemodialysis patients, with a prevalence significantly higher than that in the general population. 27.1% of hemodialysis patients experience falls. Among those followed up for over 12 months, the rate rises to 28.8%, with 14.8% having repeated falls. Significantly, despite the patients' young age, their risk of repeated falls was equivalent to that commonly observed in older persons, highlighting the significant fall risk linked to hemodialysis regardless of age. Falls in hemodialysis patients increase the risk of injury, reduce quality of life, and contribute to higher mortality rates. These findings emphasize the importance of routinely assessing motor function as part of comprehensive healthcare for hemodialysis patients to better develop interventions and improve patient outcomes.

Considering the significant implications of dynamic balance impairment, it is essential to examine aspects such as gender differences, which may affect dynamic balance performance and total motor function in hemodialysis patients.

Первичные конечные точки

  • Dynamic Balance among Hemodialysis Patients [Срок оценки: At baseline (single assessment)]

Критерии участия

Критерии включения

  • Age 20 to 60 years (both sexes)
  • Body mass index (BMI) 18.5 to 29.9 kg/m²
  • Undergoing hemodialysis three times per week
  • Duration of hemodialysis ≥1 year
  • No exercise therapy within the last 3 months
  • Able to walk independently for at least 2 minutes without assistive devices

Критерии исключения

  • Recent myocardial infarction (within 6 weeks)
  • Malignant arrhythmia or unstable angina
  • History of major surgery or fracture of the hip/knee, or hip/knee replacement
  • Severe respiratory or cardiovascular conditions affecting cardiopulmonary function
  • Severe hypotension during or after hemodialysis
  • Neurological disorders affecting balance

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Египет · 2 центра
  • Tanta General Hospital — Tanta
  • Tanta General Hospital — Tanta

Публикации

  • Blake C, O'Meara YM. Subjective and objective physical limitations in high-functioning renal dialysis patients. Nephrol Dial Transplant. 2004 Dec;19(12):3124-9. doi: 10.1093/ndt/gfh538. Epub 2004 Oct 19. PMID 15494354

Идентификаторы

NCT: NCT07555522 · HD-Balance-Gender-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗