The Effect of Walking in Kidney Transplant Patients
6. srpna 2021 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
68
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Fatma DEMIR KORKMAZ, Professor
- Telefonní číslo: +902323115506
- E-mail: fatma.demir@ege.edu.tr
Studijní záloha kontaktů
- Jméno: Tugba Nur ODEN, PhD Student
- Telefonní číslo: +902323905106
- E-mail: tugba.nur.zoturk@ege.edu.tr
Studijní místa
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Izmir, Krocan, 35040
- Nábor
- Ege university
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Kontakt:
- Fatma DEMIR KORKMAZ, Professor
- Telefonní číslo: +902323115506
- E-mail: fatma.demir@ege.edu.tr
-
Kontakt:
- Tugba Nur ODEN, PhD Student
- Telefonní číslo: +902323905106
- E-mail: tugba.nur.ozturk@ege.edu.tr
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Blood Pressure
Časové okno: 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
Časové okno: 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)
Časové okno: Change from Baseline BMI at 4 months after discharge
|
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)
Časové okno: Change from Baseline BMI at 12 months after discharge
|
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
|
|
Hemoglobin
Časové okno: Change from Baseline Hemoglobin at 4 months after discharge
|
g/dL
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Change from Baseline Hemoglobin at 4 months after discharge
|
|
Hemoglobin
Časové okno: Change from Baseline Hemoglobin at 12 months after discharge
|
g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
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|
Leukocyte
Časové okno: Change from Baseline Leukocyte at 4 months after discharge
|
10^3/µL
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Change from Baseline Leukocyte at 4 months after discharge
|
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Leukocyte
Časové okno: Change from Baseline Leukocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 12 months after discharge
|
|
Thrombocyte
Časové okno: Change from Baseline Thrombocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 4 months after discharge
|
|
Thrombocyte
Časové okno: Change from Baseline Thrombocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 12 months after discharge
|
|
Blood Glucose
Časové okno: Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
Časové okno: Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
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Change from Baseline Blood Glucose at 12 months after discharge
|
|
Sodium
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Sodium
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Potassium
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
Časové okno: 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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Serum Creatinine
Časové okno: 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
Časové okno: 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
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Bilirubin
Časové okno: 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
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Indirect Bilirubin
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
High-density lipoprotein (HDL) cholesterol
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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High-density lipoprotein (HDL) cholesterol
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
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Low-density lipoprotein (LDL) cholesterol
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Low-density lipoprotein (LDL) cholesterol
Časové okno: 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
Časové okno: 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
|
|
Aspartate Aminotransferase
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
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Alanine aminotransferase
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alanine aminotransferase
Časové okno: 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
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
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Alkaline Phosphatase
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Triglyceride
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
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Triglyceride
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
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Total Cholesterol
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
Total Cholesterol
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
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Albumin
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
g/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Albumin
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
g/dL
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Change from Baseline Sodium at 12 months after discharge
|
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glucose in urine
Časové okno: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
Časové okno: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. listopadu 2020
Primární dokončení (Očekávaný)
1. listopadu 2022
Dokončení studie (Očekávaný)
1. listopadu 2022
Termíny zápisu do studia
První předloženo
30. března 2021
První předloženo, které splnilo kritéria kontroly kvality
6. srpna 2021
První zveřejněno (Aktuální)
12. srpna 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. srpna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. srpna 2021
Naposledy ověřeno
1. srpna 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- fatma.demir1
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .