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NCT Number: NCT07666815

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

IMSS-Bienestar State Haemodialysis Centre

Colima, Coliima, 28048, Mexico

Location status: Recruiting

Location contact

Evalyn Ceballos Medica cirujana y partera

CONTACT

[email protected]

3121078792

Pedro Julian Flores Moreno, Doctor of Medical Sciences

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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.

Comparison group D Hemodialysis

Procedure

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

Primary outcomes

  1. Grasping muscle strength

    Time frame: From baseline assessments through the end of the 8-week intervention

    Measurement of results in kilograms

Study contacts

Contact information is provided by the study sponsor or research team.

Israel Pérez Palafox PALAFOX Master of Medical Sciences

CONTACT

[email protected]

+523151260402

Sponsors and collaborators

Lead sponsor

Pedro Julian Flores Moreno

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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