Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.

Официальное название

Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.

Обзор

This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.

Подробное описание

A double-blind, randomized clinical trial will be conducted in patients with chronic kidney disease undergoing maintenance hemodialysis. The study will evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity.

Participants will be allocated to one of four study groups: (1) standard hemodialysis care, (2) creatine monohydrate supplementation, (3) intradialytic exercise, and (4) creatine monohydrate supplementation combined with intradialytic exercise. The intervention period will last 8 weeks.

Body composition, biochemical parameters, and functional capacity will be assessed at baseline and after completion of the intervention period. Comparisons among study groups will be performed to determine the independent and combined effects of creatine monohydrate supplementation and intradialytic exercise.

The study is designed to generate evidence regarding the potential clinical benefits of incorporating structured exercise programs and creatine supplementation into the routine management of patients receiving maintenance hemodialysis. Findings may contribute to the development of strategies aimed at improving physical function, nutritional status, and overall health outcomes in this population.

Вмешательства

• Препарат Group A with creatine monohydrate
  Participants will receive 5 g of creatine monohydrate diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, supplementation will be administered immediately after the dialysis session. On non-dialysis days, supplementation will be administered after a meal.
• Другое Group B placebo
  Participants will receive 5 g of placebo diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, placebo will be administered immediately after the dialysis session. On non-dialysis days, placebo will be administered after a meal.
• Поведенческое Group C Intradialytic Exercise Program
  Participants will perform a supervised intradialytic exercise program during hemodialysis sessions for 8 weeks. The program will include aerobic and resistance exercises performed three times per week according to the study protocol.
• Процедура Comparison group D Hemodialysis
  Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.

Первичные конечные точки

• Grasping muscle strength [Срок оценки: From baseline assessments through the end of the 8-week intervention]

Критерии участия

Критерии включения

• atients who are treated at the State Haemodialysis Centre.

• Patients who receive haemodialysis three times a week.
• Signature of informed consent.
• Patients over 18 years of age, both men and women.
• Patients who have been on haemodialysis for no more than two years.

Критерии исключения

Patients who have had a limb amputated.

• Patients who are in a state of anuria.
• Inability to perform muscular resistance or aerobic resistance exercises.
• Patients unable to perform physical exercise.
• HIV-positive patients. Elimination.
• Patients who voluntarily withdraw from the project.
• Inability to perform physical exercise.
• Death.
• Adverse events related to creatine consumption.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• IMSS-Bienestar State Haemodialysis Centre — Colima

Идентификаторы

NCT: NCT07666815 · CEI2026/01/CR/CL/SFD/205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗