Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Israel Pérez Palafox PALAFOX Master of Medical Sciences
- 电话号码：+523151260402
- 邮箱：iperez@ucol.mx
学习地点
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Coliima
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Colima、Coliima、墨西哥、28048
- 招聘中
- IMSS-Bienestar State Haemodialysis Centre
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接触：
- Evalyn Ceballos Medica cirujana y partera
- 电话号码：3121078792
- 邮箱：eveceballoss@gmail.com
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副研究员：
- Pedro Julian Flores Moreno, Doctor of Medical Sciences
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group A
consists of hemodialysis, intradialytic exercise, and creatine monohydrate.
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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.
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安慰剂比较：Group B
consists of hemodialysis, intradialytic exercise, and placebo.
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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.
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有源比较器：Group C
consists of hemodialysis and exercise.
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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.
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假比较器：Group D
consists of hemodialysis.
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Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Grasping muscle strength
大体时间：From baseline assessments through the end of the 8-week intervention
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Measurement of results in kilograms
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From baseline assessments through the end of the 8-week intervention
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
研究数据/文件
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研究协议
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研究美国 FDA 监管的设备产品
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