The Effect of Walking in Kidney Transplant Patients
6 agosto 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Anticipato)
68
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Fatma DEMIR KORKMAZ, Professor
- Numero di telefono: +902323115506
- Email: fatma.demir@ege.edu.tr
Backup dei contatti dello studio
- Nome: Tugba Nur ODEN, PhD Student
- Numero di telefono: +902323905106
- Email: tugba.nur.zoturk@ege.edu.tr
Luoghi di studio
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Izmir, Tacchino, 35040
- Reclutamento
- Ege University
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Contatto:
- Fatma DEMIR KORKMAZ, Professor
- Numero di telefono: +902323115506
- Email: fatma.demir@ege.edu.tr
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Contatto:
- Tugba Nur ODEN, PhD Student
- Numero di telefono: +902323905106
- Email: tugba.nur.ozturk@ege.edu.tr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Blood Pressure
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
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Calcium
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Alkaline Phosphatase
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 novembre 2020
Completamento primario (Anticipato)
1 novembre 2022
Completamento dello studio (Anticipato)
1 novembre 2022
Date di iscrizione allo studio
Primo inviato
30 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
6 agosto 2021
Primo Inserito (Effettivo)
12 agosto 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 agosto 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 agosto 2021
Ultimo verificato
1 agosto 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- fatma.demir1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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