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RECRUITING
NCT07666815
PHASE1/PHASE2

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

Sponsor: Pedro Julian Flores Moreno

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-03-02

Completion Date

2026-08-07

Last Updated

2026-06-24

Healthy Volunteers

Yes

Interventions

DRUG

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.

OTHER

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.

BEHAVIORAL

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.

PROCEDURE

Comparison group D Hemodialysis

Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.

Locations (1)

IMSS-Bienestar State Haemodialysis Centre

Colima, Coliima, Mexico