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

ConditionChronic Kidney Disease 5D

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorPedro Julian Flores Moreno

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

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

Treatment groups

48 Participants

are divided into 4 treatment groups

Group A: Group AExperimental treatment 1 intervention

Group B: Group BPlacebo comparator 1 intervention

Group C: Group CActive comparator 1 intervention

Group D: Group DSham comparator 1 intervention

Trial outcomes

Primary outcomes

Grasping muscle strength

Measurement of results in kilograms

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pedro Julian Flores Moreno

Lead sponsor

Universidad de Colima

Sponsor institution

Source ClinicalTrials.gov

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