Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Официальное название

A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients

Обзор

Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. In 2021, the investigators conducted a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis to confirm the effectiveness. This study is a follow-up study, conducted as a randomized controlled trial.

Подробное описание

This is a prospective, 1:1 randomized controlled study with 40 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. Combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. All functional outcomes will be measured at 0, 4, 8 and 12 weeks after intervention. The data will be analysed using the intention-to-treat principle.

Вмешательства

• Другое exercise and nutritional support
  resistance exercise and protein supplementation including branched chain amino acids for 12 weeks

Первичные конечные точки

• Handgrip strength in Kg using a portable dyanometer [Срок оценки: 12 weeks]
• Body composition using dual energy x-ray absorptiometry (DXA) [Срок оценки: 12 weeks]
• Body composition using body composition monitor (BCM) [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• The total score of Short Physical Performance Battery(SPPB) [Срок оценки: 12 weeks]
• The second of 5 times Chair Stand Test [Срок оценки: 12 weeks]
• skeletal muscle mass index(SMI) in cm2/m2 [Срок оценки: 12 weeks]
• Glucose pattern using continuous glucose monitoring system(freestyle libre) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Patients with hemodialysis
• Community-dwellers
• Able to walk with or without assistive devices for more than 100 meters

Критерии исключения

• A person with cancer disease.
• People with psychiatric symptoms.
• A person who has an absorption disorder or has a history of resection of the small intestine or colon
• Pregnant women
• A person treated for acute bacterial infections
• A person who is in a wheelchair due to inconvenience in walking.

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

South Korea · 1 центр

• Chungnam National University Hospital — Daejeon

Идентификаторы

NCT: NCT05884138 · CNUH-ED-2023-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗