Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Israel Pérez Palafox PALAFOX Master of Medical Sciences
- Telefonnummer: +523151260402
- E-mail: iperez@ucol.mx
Studiesteder
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Coliima
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Colima, Coliima, Mexico, 28048
- Rekruttering
- IMSS-Bienestar State Haemodialysis Centre
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Kontakt:
- Evalyn Ceballos Medica cirujana y partera
- Telefonnummer: 3121078792
- E-mail: eveceballoss@gmail.com
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Underforsker:
- Pedro Julian Flores Moreno, Doctor of Medical Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group A
consists of hemodialysis, intradialytic exercise, and creatine monohydrate.
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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.
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Placebo komparator: Group B
consists of hemodialysis, intradialytic exercise, and placebo.
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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.
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Aktiv komparator: Group C
consists of hemodialysis and exercise.
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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.
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Sham-komparator: Group D
consists of hemodialysis.
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Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Grasping muscle strength
Tidsramme: From baseline assessments through the end of the 8-week intervention
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Measurement of results in kilograms
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From baseline assessments through the end of the 8-week intervention
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CEI2026/01/CR/CL/SFD/205
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Studiedata/dokumenter
-
Studieprotokol
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