Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)
14 de septiembre de 2026 actualizado por: Ricerca Nefrocenter
Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease
The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:
- Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?
- Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?
Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.
Participants will:
- Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.
- Attend hemodialysis sessions as scheduled.
- Complete physical performance and body composition assessments at baseline and after 6 months.
- Complete questionnaires about health and quality of life.
The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
312
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ersilia Satta, PhD MD
- Número de teléfono: +39 3395703091
- Correo electrónico: e.satta@consorzionefrocenter.it
Ubicaciones de estudio
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Torre del Greco, Italia, 80059
- Reclutamiento
- NefroCenter Dialysis Centers
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Contacto:
- Study Coordinator, PhD
- Número de teléfono: +39 3395703091
- Correo electrónico: e.satta@consorzionefrocenter.it
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Investigador principal:
- Ersilia Satta, PhD MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Receiving maintenance hemodialysis for more than 3 months.
- Clinically stable condition.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Unstable angina.
- Uncontrolled hypertension.
- Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions.
Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13.
Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
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Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions.
Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13).
Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
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Comparador activo: Elastic band resistance training
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions.
Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs.
Resistance was progressively adjusted according to individual tolerance and correct exercise execution.
Sessions were supervised by exercise professionals and monitored by dialysis nurses.
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Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions.
Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs.
Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.
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Sin intervención: Control
Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program.
Clinical assessments and follow-up evaluations were performed according to the study protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of intradialytic intolerance and hemodynamic instability
Periodo de tiempo: Baseline to 6 months
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Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions.
Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions.
Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded.
Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
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Baseline to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximal workload during cycle ergometer stress testing
Periodo de tiempo: Baseline to 6 months
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Changes in maximal workload achieved during cycle ergometer stress testing.
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Baseline to 6 months
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Six-minute walk test distance
Periodo de tiempo: Baseline and 6 months
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Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
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Baseline and 6 months
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Step-test performance
Periodo de tiempo: Baseline and 6 months
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Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
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Baseline and 6 months
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Chair-stand test performance
Periodo de tiempo: Baseline and 6 months
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Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
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Baseline and 6 months
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Handgrip strength
Periodo de tiempo: Baseline and 6 months
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Changes in handgrip strength measured using a hand dynamometer.
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Baseline and 6 months
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Weekly exercise time
Periodo de tiempo: Throughout the 6-month intervention period
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Changes in the total amount of exercise completed per week during the intervention period.
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Throughout the 6-month intervention period
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Fat-free mass and fat mass
Periodo de tiempo: Baseline to 6 months
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Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
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Baseline to 6 months
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Bone mineral content
Periodo de tiempo: Baseline and 6 months
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Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
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Baseline and 6 months
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Bone mineral status (T-score)
Periodo de tiempo: Baseline and 6 months
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Changes in T-score as an indicator of bone mineral status.
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Baseline and 6 months
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Appendicular skeletal muscle mass index (ASMMI)
Periodo de tiempo: Baseline and 6 months
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Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
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Baseline and 6 months
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Anthropometric circumferences
Periodo de tiempo: Baseline and 6 months
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Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
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Baseline and 6 months
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Health-related quality of life
Periodo de tiempo: Baseline to 6 months
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Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire.
The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.
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Baseline to 6 months
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Medication burden
Periodo de tiempo: Baseline to 6 months
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Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
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Baseline to 6 months
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Dialysis adequacy
Periodo de tiempo: Baseline to 6 months
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Changes in dialysis adequacy expressed as Kt/V.
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Baseline to 6 months
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Dialysis session duration
Periodo de tiempo: Baseline and 6 months
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Changes in the duration of the hemodialysis session (min).
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Baseline and 6 months
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Blood flow rate
Periodo de tiempo: Baseline and 6 months
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Changes in blood flow rate (Qb) during hemodialysis.
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Baseline and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2024
Finalización primaria (Actual)
1 de octubre de 2025
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
15 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0079556CE
- CUP E63C22002050006 (Otro número de subvención/financiamiento: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The decision regarding sharing of individual participant data (IPD) has not yet been finalized.
Data sharing will be evaluated after study completion, taking into account ethical, legal, privacy, and data protection requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .