NCT05003193

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

March 30, 2021

Last Update Submit

August 6, 2021

Conditions

Kidney Transplant; ComplicationsCardiac Disease

Keywords

transplantationexersizeheart diseaseskidneynursing care

Outcome Measures

Primary Outcomes (42)

  • Blood Pressure

    mmHg

    Change from Baseline Blood Pressure at 4 months after discharge

  • Blood Pressure

    mmHg

    Change from Baseline Blood Pressure at 12 months after discharge

  • Body Mass Index (BMI)

    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)

    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

    g/dL

    Change from Baseline Hemoglobin at 4 months after discharge

  • Hemoglobin

    g/dL

    Change from Baseline Hemoglobin at 12 months after discharge

  • Leukocyte

    10\^3/µL

    Change from Baseline Leukocyte at 4 months after discharge

  • Leukocyte

    10\^3/µL

    Change from Baseline Leukocyte at 12 months after discharge

  • Thrombocyte

    10\^3/µL

    Change from Baseline Thrombocyte at 4 months after discharge

  • Thrombocyte

    10\^3/µL

    Change from Baseline Thrombocyte at 12 months after discharge

  • Blood Glucose

    mg/dL

    Change from Baseline Blood Glucose at 4 months after discharge

  • Blood Glucose

    mg/dL

    Change from Baseline Blood Glucose at 12 months after discharge

  • Sodium

    mEq/L

    Change from Baseline Sodium at 4 months after discharge

  • Sodium

    mEq/L

    Change from Baseline Sodium at 12 months after discharge

  • Potassium

    mEq/L

    Change from Baseline Sodium at 4 months after discharge

  • Potassium

    mEq/L

    Change from Baseline Sodium at 12 months after discharge

  • Calcium

    mEq/L

    Change from Baseline Sodium at 4 months after discharge

  • Calcium

    mEq/L

    Change from Baseline Sodium at 12 months after discharge

  • Serum Creatinine

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Serum Creatinine

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Total Bilirubin

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Total Bilirubin

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Indirect Bilirubin

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Indirect Bilirubin

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • High-density lipoprotein (HDL) cholesterol

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • High-density lipoprotein (HDL) cholesterol

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Low-density lipoprotein (LDL) cholesterol

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Low-density lipoprotein (LDL) cholesterol

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Aspartate Aminotransferase

    U/L

    Change from Baseline Sodium at 4 months after discharge

  • Aspartate Aminotransferase

    U/L

    Change from Baseline Sodium at 12 months after discharge

  • Alanine aminotransferase

    U/L

    Change from Baseline Sodium at 4 months after discharge

  • Alanine aminotransferase

    U/L

    Change from Baseline Sodium at 12 months after discharge

  • Alkaline Phosphatase

    U/L

    Change from Baseline Sodium at 4 months after discharge

  • Alkaline Phosphatase

    U/L

    Change from Baseline Sodium at 12 months after discharge

  • Triglyceride

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Triglyceride

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Total Cholesterol

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • Total Cholesterol

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

  • Albumin

    g/dL

    Change from Baseline Sodium at 4 months after discharge

  • Albumin

    g/dL

    Change from Baseline Sodium at 12 months after discharge

  • glucose in urine

    mg/dL

    Change from Baseline Sodium at 4 months after discharge

  • glucose in urine

    mg/dL

    Change from Baseline Sodium at 12 months after discharge

Study Arms (2)

Using a pedometer

EXPERIMENTAL

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.

Device: pedometer

Not using a pedometer

NO INTERVENTION

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.

Interventions

pedometerDEVICE

2000 steps per day in 20 minutes for 90 days, guided by a pedometer after a kidney transplantation

Using a pedometer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

RECRUITING

Related Publications (13)

  • 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.

    PMID: 23758229BACKGROUND

  • 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.

    PMID: 26844883BACKGROUND

  • 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.

    PMID: 25845820BACKGROUND

  • 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.

    PMID: 28185297BACKGROUND

  • Aakhus S, Dahl K, Wideroe 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. doi: 10.1111/j.1399-0012.2004.00235.x.

    PMID: 15344967BACKGROUND

  • 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.

    PMID: 16969281BACKGROUND

  • Berben L, Engberg SJ, Rossmeissl A, Gordon EJ, Kugler C, Schmidt-Trucksass 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.

    PMID: 30461720BACKGROUND

  • 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.

    PMID: 24635476BACKGROUND

  • 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.

    PMID: 19619168BACKGROUND

  • 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.

    PMID: 21200336BACKGROUND

  • Svensson M, Jardine A, Fellstrom 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.

    PMID: 22790074BACKGROUND

  • 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.

    PMID: 17671236BACKGROUND

  • 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.

    PMID: 19845597BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Fatma DEMIR KORKMAZ, Professor

    Ege University Faculty of Nursing 35000, Izmir, Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma DEMIR KORKMAZ, Professor

CONTACT

+902323115506fatma.demir@ege.edu.tr

Tugba Nur ODEN, PhD Student

CONTACT

+902323905106tugba.nur.zoturk@ege.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2021

First Posted

August 12, 2021

Study Start

November 19, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

TU(1)