The Effect of Walking in Kidney Transplant Patients
6 sierpnia 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Oczekiwany)
68
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Fatma DEMIR KORKMAZ, Professor
- Numer telefonu: +902323115506
- E-mail: fatma.demir@ege.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: Tugba Nur ODEN, PhD Student
- Numer telefonu: +902323905106
- E-mail: tugba.nur.zoturk@ege.edu.tr
Lokalizacje studiów
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-
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Izmir, Indyk, 35040
- Rekrutacyjny
- Ege university
-
Kontakt:
- Fatma DEMIR KORKMAZ, Professor
- Numer telefonu: +902323115506
- E-mail: fatma.demir@ege.edu.tr
-
Kontakt:
- Tugba Nur ODEN, PhD Student
- Numer telefonu: +902323905106
- E-mail: tugba.nur.ozturk@ege.edu.tr
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 65 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Brak interwencji: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Blood Pressure
Ramy czasowe: Change from Baseline Blood Pressure at 4 months after discharge
|
mmHg
|
Change from Baseline Blood Pressure at 4 months after discharge
|
|
Blood Pressure
Ramy czasowe: Change from Baseline Blood Pressure at 12 months after discharge
|
mmHg
|
Change from Baseline Blood Pressure at 12 months after discharge
|
|
Body Mass Index (BMI)
Ramy czasowe: 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
|
Change from Baseline BMI at 4 months after discharge
|
|
Body Mass Index (BMI)
Ramy czasowe: 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
|
Change from Baseline BMI at 12 months after discharge
|
|
Hemoglobin
Ramy czasowe: Change from Baseline Hemoglobin at 4 months after discharge
|
g/dL
|
Change from Baseline Hemoglobin at 4 months after discharge
|
|
Hemoglobin
Ramy czasowe: Change from Baseline Hemoglobin at 12 months after discharge
|
g/dL
|
Change from Baseline Hemoglobin at 12 months after discharge
|
|
Leukocyte
Ramy czasowe: Change from Baseline Leukocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 4 months after discharge
|
|
Leukocyte
Ramy czasowe: Change from Baseline Leukocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 12 months after discharge
|
|
Thrombocyte
Ramy czasowe: Change from Baseline Thrombocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 4 months after discharge
|
|
Thrombocyte
Ramy czasowe: Change from Baseline Thrombocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 12 months after discharge
|
|
Blood Glucose
Ramy czasowe: Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
Ramy czasowe: Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 12 months after discharge
|
|
Sodium
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Sodium
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Potassium
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Serum Creatinine
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Serum Creatinine
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Total Bilirubin
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Total Bilirubin
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Indirect Bilirubin
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Indirect Bilirubin
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
High-density lipoprotein (HDL) cholesterol
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
High-density lipoprotein (HDL) cholesterol
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Low-density lipoprotein (LDL) cholesterol
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Low-density lipoprotein (LDL) cholesterol
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Aspartate Aminotransferase
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Aspartate Aminotransferase
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Alanine aminotransferase
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alanine aminotransferase
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Alkaline Phosphatase
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alkaline Phosphatase
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Triglyceride
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Triglyceride
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Total Cholesterol
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Total Cholesterol
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Albumin
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
g/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Albumin
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
g/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
glucose in urine
Ramy czasowe: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
Ramy czasowe: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 listopada 2020
Zakończenie podstawowe (Oczekiwany)
1 listopada 2022
Ukończenie studiów (Oczekiwany)
1 listopada 2022
Daty rejestracji na studia
Pierwszy przesłany
30 marca 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 sierpnia 2021
Pierwszy wysłany (Rzeczywisty)
12 sierpnia 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 sierpnia 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 sierpnia 2021
Ostatnia weryfikacja
1 sierpnia 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- fatma.demir1
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .