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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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