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

June 18, 2026 updated by: Pedro Julian Flores Moreno

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Israel Pérez Palafox PALAFOX Master of Medical Sciences
  • Phone Number: +523151260402
  • Email: iperez@ucol.mx

Study Locations

  • Mexico
    • Coliima
      • Colima, Coliima, Mexico, 28048
        • Recruiting
        • IMSS-Bienestar State Haemodialysis Centre
        • Contact:
        • Sub-Investigator:
          • Pedro Julian Flores Moreno, Doctor of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
consists of hemodialysis, intradialytic exercise, and creatine monohydrate.
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.
Placebo Comparator: Group B
consists of hemodialysis, intradialytic exercise, and placebo.
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.
Active Comparator: Group C
consists of hemodialysis and exercise.
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.
Sham Comparator: Group D
consists of hemodialysis.
Procedure: Comparison group D Hemodialysis
Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grasping muscle strength
Time Frame: From baseline assessments through the end of the 8-week intervention
Measurement of results in kilograms
From baseline assessments through the end of the 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pedro Julian Flores Moreno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

July 22, 2026

Study Completion (Estimated)

August 7, 2026

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI2026/01/CR/CL/SFD/205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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..

IPD Sharing Time Frame

The information will be available as of August 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Study Protocol
    Information identifier: Permit required
    Information comments: request permission through the link

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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