The Effect of Walking in Kidney Transplant Patients
6. August 2021 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
68
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Fatma DEMIR KORKMAZ, Professor
- Telefonnummer: +902323115506
- E-Mail: fatma.demir@ege.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Tugba Nur ODEN, PhD Student
- Telefonnummer: +902323905106
- E-Mail: tugba.nur.zoturk@ege.edu.tr
Studienorte
-
-
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Izmir, Truthahn, 35040
- Rekrutierung
- Ege university
-
Kontakt:
- Fatma DEMIR KORKMAZ, Professor
- Telefonnummer: +902323115506
- E-Mail: fatma.demir@ege.edu.tr
-
Kontakt:
- Tugba Nur ODEN, PhD Student
- Telefonnummer: +902323905106
- E-Mail: tugba.nur.ozturk@ege.edu.tr
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Blood Pressure
Zeitfenster: Change from Baseline Blood Pressure at 4 months after discharge
|
mmHg
|
Change from Baseline Blood Pressure at 4 months after discharge
|
|
Blood Pressure
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Change from Baseline Hemoglobin at 4 months after discharge
|
g/dL
|
Change from Baseline Hemoglobin at 4 months after discharge
|
|
Hemoglobin
Zeitfenster: Change from Baseline Hemoglobin at 12 months after discharge
|
g/dL
|
Change from Baseline Hemoglobin at 12 months after discharge
|
|
Leukocyte
Zeitfenster: Change from Baseline Leukocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 4 months after discharge
|
|
Leukocyte
Zeitfenster: Change from Baseline Leukocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 12 months after discharge
|
|
Thrombocyte
Zeitfenster: Change from Baseline Thrombocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 4 months after discharge
|
|
Thrombocyte
Zeitfenster: Change from Baseline Thrombocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 12 months after discharge
|
|
Blood Glucose
Zeitfenster: Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
Zeitfenster: Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 12 months after discharge
|
|
Sodium
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Sodium
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Potassium
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Serum Creatinine
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Serum Creatinine
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Total Bilirubin
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Total Bilirubin
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Indirect Bilirubin
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Indirect Bilirubin
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Aspartate Aminotransferase
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Aspartate Aminotransferase
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Alanine aminotransferase
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alanine aminotransferase
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Alkaline Phosphatase
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alkaline Phosphatase
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Triglyceride
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Triglyceride
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Total Cholesterol
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Total Cholesterol
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Albumin
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
g/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
Albumin
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
g/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
glucose in urine
Zeitfenster: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
Zeitfenster: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
19. November 2020
Primärer Abschluss (Voraussichtlich)
1. November 2022
Studienabschluss (Voraussichtlich)
1. November 2022
Studienanmeldedaten
Zuerst eingereicht
30. März 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. August 2021
Zuerst gepostet (Tatsächlich)
12. August 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. August 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. August 2021
Zuletzt verifiziert
1. August 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- fatma.demir1
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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