The Effect of Walking in Kidney Transplant Patients
6. august 2021 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
68
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Fatma DEMIR KORKMAZ, Professor
- Telefonnummer: +902323115506
- E-post: fatma.demir@ege.edu.tr
Studer Kontakt Backup
- Navn: Tugba Nur ODEN, PhD Student
- Telefonnummer: +902323905106
- E-post: tugba.nur.zoturk@ege.edu.tr
Studiesteder
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Izmir, Tyrkia, 35040
- Rekruttering
- Ege university
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Ta kontakt med:
- Fatma DEMIR KORKMAZ, Professor
- Telefonnummer: +902323115506
- E-post: fatma.demir@ege.edu.tr
-
Ta kontakt med:
- Tugba Nur ODEN, PhD Student
- Telefonnummer: +902323905106
- E-post: tugba.nur.ozturk@ege.edu.tr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure
Tidsramme: Change from Baseline Blood Pressure at 4 months after discharge
|
mmHg
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Change from Baseline Blood Pressure at 4 months after discharge
|
|
Blood Pressure
Tidsramme: 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)
Tidsramme: 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
|
|
Body Mass Index (BMI)
Tidsramme: 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
Tidsramme: Change from Baseline Hemoglobin at 4 months after discharge
|
g/dL
|
Change from Baseline Hemoglobin at 4 months after discharge
|
|
Hemoglobin
Tidsramme: Change from Baseline Hemoglobin at 12 months after discharge
|
g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
|
|
Leukocyte
Tidsramme: Change from Baseline Leukocyte at 4 months after discharge
|
10^3/µL
|
Change from Baseline Leukocyte at 4 months after discharge
|
|
Leukocyte
Tidsramme: Change from Baseline Leukocyte at 12 months after discharge
|
10^3/µL
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Change from Baseline Leukocyte at 12 months after discharge
|
|
Thrombocyte
Tidsramme: Change from Baseline Thrombocyte at 4 months after discharge
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10^3/µL
|
Change from Baseline Thrombocyte at 4 months after discharge
|
|
Thrombocyte
Tidsramme: Change from Baseline Thrombocyte at 12 months after discharge
|
10^3/µL
|
Change from Baseline Thrombocyte at 12 months after discharge
|
|
Blood Glucose
Tidsramme: Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
Tidsramme: Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 12 months after discharge
|
|
Sodium
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Sodium
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Potassium
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Serum Creatinine
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
Serum Creatinine
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
Total Bilirubin
Tidsramme: 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 Bilirubin
Tidsramme: 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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Indirect Bilirubin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
Low-density lipoprotein (LDL) cholesterol
Tidsramme: 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
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Aspartate Aminotransferase
Tidsramme: 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
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
U/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Alanine aminotransferase
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alanine aminotransferase
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Alkaline Phosphatase
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alkaline Phosphatase
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Triglyceride
Tidsramme: 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
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
Total Cholesterol
Tidsramme: 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
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
Albumin
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
g/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
Albumin
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
g/dL
|
Change from Baseline Sodium at 12 months after discharge
|
|
glucose in urine
Tidsramme: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
Tidsramme: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. november 2020
Primær fullføring (Forventet)
1. november 2022
Studiet fullført (Forventet)
1. november 2022
Datoer for studieregistrering
Først innsendt
30. mars 2021
Først innsendt som oppfylte QC-kriteriene
6. august 2021
Først lagt ut (Faktiske)
12. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- fatma.demir1
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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