The Effect of Walking in Kidney Transplant Patients

NCT ID: NCT05003193

Last Updated: 2021-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplant; Complications Cardiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

pedometer

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pedometer

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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FATMA DEMIR KORKMAZ

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma DEMIR KORKMAZ, Professor

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Nursing 35000, Izmir, Turkey

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatma DEMIR KORKMAZ, Professor

Role: CONTACT

+902323115506

Tugba Nur ODEN, PhD Student

Role: CONTACT

+902323905106

Facility Contacts

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Fatma DEMIR KORKMAZ, Professor

Role: primary

+902323115506

Tugba Nur ODEN, PhD Student

Role: backup

+902323905106

References

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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.

Reference Type BACKGROUND
PMID: 23758229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26844883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25845820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28185297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15344967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16969281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30461720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24635476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19619168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21200336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22790074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17671236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19845597 (View on PubMed)

Other Identifiers

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fatma.demir1

Identifier Type: -

Identifier Source: org_study_id

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