IMSS-Bienestar State Haemodialysis Centre
Colima, Coliima, 28048, Mexico
Location status: Recruiting
Location contact
Evalyn Ceballos Medica cirujana y partera
CONTACT
Pedro Julian Flores Moreno, Doctor of Medical Sciences
SUB_INVESTIGATOR
NCT Number: NCT07666815
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Colima, Coliima, 28048, Mexico
Location status: Recruiting
Evalyn Ceballos Medica cirujana y partera
CONTACT
Pedro Julian Flores Moreno, Doctor of Medical Sciences
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who have had a limb amputated.
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.
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.
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.
Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.
Time frame: From baseline assessments through the end of the 8-week intervention
Measurement of results in kilograms
Contact information is provided by the study sponsor or research team.
Pedro Julian Flores Moreno
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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