Chronic Kidney Disease 5D
Conditions
Keywords
Creatine, Hemodialysis, Functionality
Brief summary
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.
Detailed description
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.
Interventions
DRUGGroup 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.
OTHERGroup 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.
BEHAVIORALGroup 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.
PROCEDUREComparison group D Hemodialysis
Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.
Sponsors
Pedro Julian Flores Moreno
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grasping muscle strength | From baseline assessments through the end of the 8-week intervention | Measurement of results in kilograms |
Countries
Mexico
Contacts
CONTACTIsrael Pérez Palafox PALAFOX Master of Medical Sciences
Outcome results
None listed