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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | consists of hemodialysis, intradialytic exercise, and creatine monohydrate. |
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| Group B | Placebo Comparator | consists of hemodialysis, intradialytic exercise, and placebo. |
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| Group C | Active Comparator | consists of hemodialysis and exercise. |
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| Group D | Sham Comparator | consists of hemodialysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A with creatine monohydrate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Grasping muscle strength | Measurement of results in kilograms | From baseline assessments through the end of the 8-week intervention |
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Inclusion Criteria:
atients who are treated at the State Haemodialysis Centre.
Exclusion Criteria:
Patients who have had a limb amputated.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Israel Pérez Palafox PALAFOX Master of Medical Sciences | Contact | +523151260402 | iperez@ucol.mx |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMSS-Bienestar State Haemodialysis Centre | Recruiting | Colima | Coliima | 28048 | Mexico |
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| Label | URL |
|---|---|
| Effect of Creatine Supplementation on Body Composition and Malnutrition-Inflammation Score in Hemodialysis Patients: An Exploratory 1-Year, Balanced, Double-Blind Design | View source |
| Oral creatine in hemodialysis patients increases physical functional capacity and muscle mass, an open label study | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Permit required | Study Protocol | View IPD |
In order to have access to these data, other researchers must be performing the same methodological design, so there is no point in sharing it with a different study design..
The information will be available as of August 2026
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Study divided into four groups: Group A consists of hemodialysis, intradialytic exercise, and creatine monohydrate. Group B consists of hemodialysis, intradialytic exercise, and placebo.
Group C consists of hemodialysis and exercise. Group D consists of hemodialysis.
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The study will be double-blind, meaning that patients will not know which treatment group they are in, and the principal investigator will not know which patients are taking creatine monohydrate or a placebo.
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| Group B placebo | Other | 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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| Group C Intradialytic Exercise Program | Behavioral | 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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| Comparison group D Hemodialysis | Procedure | Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center. |
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request permission through the link |
| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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