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Идёт набор NCT07361146

A Comparative Study of Intradialytic vs. Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial

Без фазы С лечением End-stage Renal Disease (ESRD) Chronic Kidney Disease Hemodialysis Patients Physical Rehabilitation During Dialysis

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: Physical Therapy Exercise Program.
Кому может быть актуально
Состояния в реестре: End-stage Renal Disease (ESRD), Chronic Kidney Disease, Hemodialysis Patients, Physical Rehabilitation During Dialysis. Базовые параметры: 21 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
Кувейт
Следующий шаг
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Официальное название

A Comparative Study of Intradialytic Versus Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to compare the effectiveness of two different timings of physical therapy for individuals undergoing hemodialysis: intradialytic (during dialysis) and pre-dialysis (before dialysis). The study seeks to determine which approach provides better improvements in physical function, quality of life, and biochemical outcomes such as hemoglobin and electrolyte levels. A total of 72 adult participants with end-stage renal disease (ESRD) receiving hemodialysis will be randomly assigned to one of two groups. Both groups will receive standardized educational sessions on the benefits and safety of exercise before beginning the intervention. Participants in the intradialytic group will perform supervised exercises during their dialysis sessions, while those in the pre-dialysis group will complete similar exercises before their dialysis sessions. Each participant will undergo the intervention twice per week for 12 weeks. Primary outcomes include physical function, assessed using the Six-Minute Walk Test and the Five Times Sit-to-Stand Test. Secondary outcomes include hemoglobin levels, electrolyte balance, and health-related quality of life measured by the KDQOL questionnaire. The study will be conducted at Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center, Kuwait, following ethical approval from the Ministry of Health Research Ethics Committee. The results are expected to inform best practices for integrating physical therapy into dialysis care to enhance the health, safety, and well-being of individuals undergoing hemodialysis.

Вмешательства

  • Поведенческое Physical Therapy Exercise Program
    A structured physical therapy program including warm-up, strengthening, balance, and stretching exercises delivered either during or before hemodialysis sessions (twice weekly for 12 weeks).

Первичные конечные точки

  • Six-Minute Walk Test (6MWT) [Срок оценки: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
  • Quality of Life (Kidney Disease Quality of Life - KDQOL) [Срок оценки: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
  • Five Times Sit-to-Stand Test (FTSST) [Срок оценки: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
Вторичные конечные точки (5)
  • Hemoglobin Level [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
  • Serum Potassium Level [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
  • Serum Sodium Level [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
  • Serum Calcium Level [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
  • Serum Phosphorus Level [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]

Критерии участия

Критерии включения

  • Adults aged between 21 and 65 years.
  • Diagnosed with end-stage renal disease (ESRD).
  • Undergoing maintenance hemodialysis for at least 3 months.
  • Medically stable and cleared by the nephrologist to participate in moderate physical exercise.
  • Able to understand and follow verbal instructions and provide informed consent.

Критерии исключения

  • Uncontrolled hypertension, recent myocardial infarction, or unstable angina.
  • Severe musculoskeletal, neurological, or cardiovascular disorders that limit physical activity.
  • Active infection, fever, or open wounds.
  • Recent hospitalization within the past month.
  • Participation in any other structured exercise program within the last 3 months.

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
Открытое
Основная цель
Лечение

Центры проведения

Кувейт · 1 центр
  • Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center — Hawalli

Идентификаторы

NCT: NCT07361146 · 2024/2681 · IRB-2024-2681

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗