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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Israel Pérez Palafox PALAFOX Master of Medical Sciences
- Número de teléfono: +523151260402
- Correo electrónico: iperez@ucol.mx
Ubicaciones de estudio
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Coliima
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Colima, Coliima, México, 28048
- Reclutamiento
- IMSS-Bienestar State Haemodialysis Centre
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Contacto:
- Evalyn Ceballos Medica cirujana y partera
- Número de teléfono: 3121078792
- Correo electrónico: eveceballoss@gmail.com
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Sub-Investigador:
- Pedro Julian Flores Moreno, Doctor of Medical Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador de placebos: 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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Comparador activo: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Grasping muscle strength
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CEI2026/01/CR/CL/SFD/205
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Datos del estudio/Documentos
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Protocolo de estudio
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Información sobre medicamentos y dispositivos, documentos del estudio
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