The Effect of Walking in Kidney Transplant Patients
6 de agosto de 2021 actualizado por: FATMA DEMIR KORKMAZ, Ege University
The Effect of Pedometer Assisted Walking on Physical Activity Level and Metabolic Parameters in Patients With Renal Transplantation
Cardiovascular diseases are among the most common causes of death in kidney transplant patients.
Physical activity is of great importance in preventing cardiovascular diseases after transplantation.
Although regular physical activity is recommended in international guidelines to prevent post-transplant mortality and morbidity in kidney transplant patients, studies have shown that patients do not follow regular physical activity instructions.The aim of our project is to examine the effect of pedometer-assisted physical activity on metabolic parameters after kidney transplantation.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
Patients with kidney transplant surgery will be randomized to the intervention (n: 34) and control groups (n: 34), respectively, according to the transplant surgery date.
Intervention and Control groups will be given the same training on the importance of physical activity during discharge training.
The pedometer will be given to the intervention group to evaluate the activity level, and it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge.
Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days.
Patients in the control group will only be advised to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days.
Metabolic parameters of the patients in the intervention and control groups will be examined at the end of the 4th and 12th months.
These parameters are blood pressure, body mass index, complete blood count (hemoglobin, leukocyte, thrombocyte), blood glucose, sodium, potassium, calcium, liver enzymes, serum creatinine, total and indirect bilirubin, albumin and total cholesterol levels.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
68
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: Fatma DEMIR KORKMAZ, Professor
- Número de teléfono: +902323115506
- Correo electrónico: fatma.demir@ege.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Tugba Nur ODEN, PhD Student
- Número de teléfono: +902323905106
- Correo electrónico: tugba.nur.zoturk@ege.edu.tr
Ubicaciones de estudio
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Izmir, Pavo, 35040
- Reclutamiento
- Ege university
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Contacto:
- Fatma DEMIR KORKMAZ, Professor
- Número de teléfono: +902323115506
- Correo electrónico: fatma.demir@ege.edu.tr
-
Contacto:
- Tugba Nur ODEN, PhD Student
- Número de teléfono: +902323905106
- Correo electrónico: tugba.nur.ozturk@ege.edu.tr
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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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria: • Over the age of 18 and under the age of 65,
- Kidney transplantation at the center where the study was conducted between the research dates,
- There is no activity restriction recommendation by the physician,
- Patients who agree to participate in the study.
Exclusion Criteria:
- Multiple organ transplantation at the same time,
- Death or graft loss/rejection in the hospital before discharge,
- Patients with physical activity restrictions by the physician,
- Patients who are re-hospitalized within the first 3 months after discharge
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Using a pedometer
The pedometer will be given to the intervention group to evaluate the activity level and to encourage a walk , it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge.
Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days.
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2000 steps per day in 20 minutes for 90 days, guided by a pedometer after a kidney transplantation
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Sin intervención: Not using a pedometer
The control group will not be given a pedometer.Patients in the control group will only be instructed to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood Pressure
Periodo de tiempo: Change from Baseline Blood Pressure at 4 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 4 months after discharge
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Blood Pressure
Periodo de tiempo: Change from Baseline Blood Pressure at 12 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 12 months after discharge
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Body Mass Index (BMI)
Periodo de tiempo: Change from Baseline BMI at 4 months after discharge
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BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 4 months after discharge
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Body Mass Index (BMI)
Periodo de tiempo: Change from Baseline BMI at 12 months after discharge
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BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 12 months after discharge
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Hemoglobin
Periodo de tiempo: Change from Baseline Hemoglobin at 4 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 4 months after discharge
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Hemoglobin
Periodo de tiempo: Change from Baseline Hemoglobin at 12 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
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Leukocyte
Periodo de tiempo: Change from Baseline Leukocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 4 months after discharge
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Leukocyte
Periodo de tiempo: Change from Baseline Leukocyte at 12 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 12 months after discharge
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Thrombocyte
Periodo de tiempo: Change from Baseline Thrombocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Thrombocyte at 4 months after discharge
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Thrombocyte
Periodo de tiempo: Change from Baseline Thrombocyte at 12 months after discharge
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10^3/µL
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Change from Baseline Thrombocyte at 12 months after discharge
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Blood Glucose
Periodo de tiempo: Change from Baseline Blood Glucose at 4 months after discharge
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mg/dL
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Change from Baseline Blood Glucose at 4 months after discharge
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Blood Glucose
Periodo de tiempo: Change from Baseline Blood Glucose at 12 months after discharge
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mg/dL
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Change from Baseline Blood Glucose at 12 months after discharge
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Sodium
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mEq/L
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Change from Baseline Sodium at 4 months after discharge
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Sodium
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mEq/L
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Change from Baseline Sodium at 12 months after discharge
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Potassium
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
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Change from Baseline Sodium at 4 months after discharge
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Potassium
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
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Calcium
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
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Change from Baseline Sodium at 4 months after discharge
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Calcium
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mEq/L
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Change from Baseline Sodium at 12 months after discharge
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Serum Creatinine
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Serum Creatinine
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Total Bilirubin
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Bilirubin
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Indirect Bilirubin
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Indirect Bilirubin
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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High-density lipoprotein (HDL) cholesterol
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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High-density lipoprotein (HDL) cholesterol
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Low-density lipoprotein (LDL) cholesterol
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Low-density lipoprotein (LDL) cholesterol
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Aspartate Aminotransferase
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Aspartate Aminotransferase
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
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Alanine aminotransferase
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Alanine aminotransferase
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
|
U/L
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Change from Baseline Sodium at 12 months after discharge
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Alkaline Phosphatase
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Alkaline Phosphatase
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
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Triglyceride
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Triglyceride
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Total Cholesterol
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Cholesterol
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Albumin
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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g/dL
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Change from Baseline Sodium at 4 months after discharge
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Albumin
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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g/dL
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Change from Baseline Sodium at 12 months after discharge
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glucose in urine
Periodo de tiempo: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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glucose in urine
Periodo de tiempo: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
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.
Publicaciones Generales
- Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.
- Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
- Zelle DM, Corpeleijn E, Klaassen G, Schutte E, Navis G, Bakker SJ. Fear of Movement and Low Self-Efficacy Are Important Barriers in Physical Activity after Renal Transplantation. PLoS One. 2016 Feb 4;11(2):e0147609. doi: 10.1371/journal.pone.0147609. eCollection 2016.
- Lorenz EC, Amer H, Dean PG, Stegall MD, Cosio FG, Cheville AL. Adherence to a pedometer-based physical activity intervention following kidney transplant and impact on metabolic parameters. Clin Transplant. 2015 Jun;29(6):560-8. doi: 10.1111/ctr.12553. Epub 2015 May 26.
- Gustaw T, Schoo E, Barbalinardo C, Rodrigues N, Zameni Y, Motta VN, Mathur S, Janaudis-Ferreira T. Physical activity in solid organ transplant recipients: Participation, predictors, barriers, and facilitators. Clin Transplant. 2017 Apr;31(4). doi: 10.1111/ctr.12929. Epub 2017 Mar 14.
- Aakhus S, Dahl K, Widerøe TE. Cardiovascular disease in stable renal transplant patients in Norway: morbidity and mortality during a 5-yr follow-up. Clin Transplant. 2004 Oct;18(5):596-604.
- Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation. 2006 Sep 15;82(5):603-11. doi: 10.1097/01.tp.0000235527.81917.fe.
- Berben L, Engberg SJ, Rossmeissl A, Gordon EJ, Kugler C, Schmidt-Trucksäss A, Klem ML, Sereika SM, De Simone P, Dobbels F, De Geest SM; B-SERIOUS consortium. Correlates and Outcomes of Low Physical Activity Posttransplant: A Systematic Review and Meta-Analysis. Transplantation. 2019 Apr;103(4):679-688. doi: 10.1097/TP.0000000000002543.
- Dontje ML, de Greef MH, Krijnen WP, Corpeleijn E, Kok T, Bakker SJ, Stolk RP, van der Schans CP. Longitudinal measurement of physical activity following kidney transplantation. Clin Transplant. 2014 Apr;28(4):394-402. doi: 10.1111/ctr.12325. Epub 2014 Mar 17.
- Gordon EJ, Prohaska TR, Gallant MP, Sehgal AR, Strogatz D, Yucel R, Conti D, Siminoff LA. Longitudinal analysis of physical activity, fluid intake, and graft function among kidney transplant recipients. Transpl Int. 2009 Oct;22(10):990-8. doi: 10.1111/j.1432-2277.2009.00917.x. Epub 2009 Jul 10.
- Hawkins MS, Sevick MA, Richardson CR, Fried LF, Arena VC, Kriska AM. Association between physical activity and kidney function: National Health and Nutrition Examination Survey. Med Sci Sports Exerc. 2011 Aug;43(8):1457-64. doi: 10.1249/MSS.0b013e31820c0130.
- Svensson M, Jardine A, Fellström B, Holdaas H. Prevention of cardiovascular disease after renal transplantation. Curr Opin Organ Transplant. 2012 Aug;17(4):393-400. doi: 10.1097/MOT.0b013e3283560a3b. Review.
- Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
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)
19 de noviembre de 2020
Finalización primaria (Anticipado)
1 de noviembre de 2022
Finalización del estudio (Anticipado)
1 de noviembre de 2022
Fechas de registro del estudio
Enviado por primera vez
30 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2021
Publicado por primera vez (Actual)
12 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- fatma.demir1
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. .