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

NCT07666815 | Recruiting Phase 1

• 1 other identifier: CEI2026/01/CR/CL/SFD/205
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease 5D

Keywords

Creatine; Hemodialysis; Functionality

Outcome Measures

Primary Outcomes (1)

• Grasping muscle strength

  Measurement of results in kilograms

  From baseline assessments through the end of the 8-week intervention

Study Arms (4)

Group A

EXPERIMENTAL

consists of hemodialysis, intradialytic exercise, and creatine monohydrate.

Drug: Group A with creatine monohydrate

Group B

PLACEBO COMPARATOR

consists of hemodialysis, intradialytic exercise, and placebo.

Other: Group B placebo

Group C

ACTIVE COMPARATOR

consists of hemodialysis and exercise.

Behavioral: Group C Intradialytic Exercise Program

Group D

SHAM COMPARATOR

consists of hemodialysis.

Procedure: Comparison group D Hemodialysis

Interventions

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.

Group A

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.

Group B

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.

Group C

Comparison group D Hemodialysis PROCEDURE

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

Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pedro Julian Flores Moreno: lead

Study Sites (1)

IMSS-Bienestar State Haemodialysis Centre

Colima, Coliima, 28048, Mexico

RECRUITING

Related Links

• Effect of Creatine Supplementation on Body Composition and Malnutrition-Inflammation Score in Hemodialysis Patients: An Exploratory 1-Year, Balanced, Double-Blind Design
• Oral creatine in hemodialysis patients increases physical functional capacity and muscle mass, an open label study

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Israel Pérez Palafox PALAFOX Master of Medical Sciences

CONTACT

+523151260402; iperez@ucol.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. in Science

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 24, 2026
• Study Start: March 2, 2026
• Primary Completion: July 22, 2026
• Study Completion (Estimated): August 7, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The information will be available as of August 2026

Locations

ME (1)