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Kidney Transplant; ComplicationsNCT05003193

The Effect of Walking in Kidney Transplant Patients

A study testing pedometer in people with Kidney Transplant; Complications and Cardiac Disease, run by Ege University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
pedometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Nov 2020to Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Fatma DEMIR KORKMAZ, Professor contact

+902323115506

fatma.demir@ege.edu.tr

Tugba Nur ODEN, PhD Student contact

+902323905106

tugba.nur.zoturk@ege.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Ege University

    Izmir, 35040

    Fatma DEMIR KORKMAZ, Professor, +902323115506, fatma.demir@ege.edu.tr

    Tugba Nur ODEN, PhD Student, +902323905106, tugba.nur.ozturk@ege.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
pedometer
Keywords
transplantation, exersize, heart diseases, kidney, nursing care
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pedometerDevice

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

Study groups in NCT05003193
Study groupRoleWhat they receive
Using a pedometerExperimentalThe 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.
Receives: Device: pedometer
Not using a pedometerNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    mmHg

    Measured: Change from Baseline Blood Pressure at 4 months after discharge

  2. Blood Pressure

    mmHg

    Measured: Change from Baseline Blood Pressure at 12 months after discharge

  3. Body Mass Index (BMI)

    BMI is weight in kilograms divided by height in meters squared. Formula: weight (kg) / [height (m)]2

    Measured: Change from Baseline BMI at 4 months after discharge

  4. Body Mass Index (BMI)

    BMI is weight in kilograms divided by height in meters squared. Formula: weight (kg) / [height (m)]2

    Measured: Change from Baseline BMI at 12 months after discharge

  5. Hemoglobin

    g/dL

    Measured: Change from Baseline Hemoglobin at 4 months after discharge

  6. Hemoglobin

    g/dL

    Measured: Change from Baseline Hemoglobin at 12 months after discharge

  7. Leukocyte

    10^3/µL

    Measured: Change from Baseline Leukocyte at 4 months after discharge

  8. Leukocyte

    10^3/µL

    Measured: Change from Baseline Leukocyte at 12 months after discharge

  9. Thrombocyte

    10^3/µL

    Measured: Change from Baseline Thrombocyte at 4 months after discharge

  10. Thrombocyte

    10^3/µL

    Measured: Change from Baseline Thrombocyte at 12 months after discharge

  11. Blood Glucose

    mg/dL

    Measured: Change from Baseline Blood Glucose at 4 months after discharge

  12. Blood Glucose

    mg/dL

    Measured: Change from Baseline Blood Glucose at 12 months after discharge

  13. Sodium

    mEq/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  14. Sodium

    mEq/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  15. Potassium

    mEq/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  16. Potassium

    mEq/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  17. Calcium

    mEq/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  18. Calcium

    mEq/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  19. Serum Creatinine

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  20. Serum Creatinine

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  21. Total Bilirubin

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  22. Total Bilirubin

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  23. Indirect Bilirubin

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  24. Indirect Bilirubin

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  25. High-density lipoprotein (HDL) cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  26. High-density lipoprotein (HDL) cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  27. Low-density lipoprotein (LDL) cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  28. Low-density lipoprotein (LDL) cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  29. Aspartate Aminotransferase

    U/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  30. Aspartate Aminotransferase

    U/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  31. Alanine aminotransferase

    U/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  32. Alanine aminotransferase

    U/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  33. Alkaline Phosphatase

    U/L

    Measured: Change from Baseline Sodium at 4 months after discharge

  34. Alkaline Phosphatase

    U/L

    Measured: Change from Baseline Sodium at 12 months after discharge

  35. Triglyceride

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  36. Triglyceride

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  37. Total Cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  38. Total Cholesterol

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  39. Albumin

    g/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  40. Albumin

    g/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

  41. glucose in urine

    mg/dL

    Measured: Change from Baseline Sodium at 4 months after discharge

  42. glucose in urine

    mg/dL

    Measured: Change from Baseline Sodium at 12 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start19 Nov 2020
  3. Primary completionNov 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003193
Sponsor's protocol ID
fatma.demir1
Status last verified
Aug 2021
First submitted
30 Mar 2021
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23758229

  • 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.

    PubMed 26844883

  • 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.

    PubMed 25845820

  • 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.

    PubMed 28185297

  • 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.

    PubMed 15344967

  • 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.

    PubMed 16969281

  • 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.

    PubMed 30461720

  • 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.

    PubMed 24635476

  • 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.

    PubMed 19619168

  • 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.

    PubMed 21200336

  • 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.

    PubMed 22790074

  • 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.

    PubMed 17671236

  • 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.

    PubMed 19845597

Questions about this trial

What is this clinical trial studying?

A study testing pedometer in people with Kidney Transplant; Complications and Cardiac Disease, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fatma DEMIR KORKMAZ, Professor (+902323115506, fatma.demir@ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Change from Baseline Blood Pressure at 4 months after discharge). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003193, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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