The Effect of Walking in Kidney Transplant Patients

Sponsor
Ege University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05003193
Collaborator
(none)
68
1
2
23.4
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: pedometer
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Pedometer Assisted Walking on Physical Activity Level and Metabolic Parameters in Patients With Renal Transplantation
Actual Study Start Date :
Nov 19, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure [Change from Baseline Blood Pressure at 4 months after discharge]

    mmHg

  2. Blood Pressure [Change from Baseline Blood Pressure at 12 months after discharge]

    mmHg

  3. Body Mass Index (BMI) [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

  4. Body Mass Index (BMI) [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

  5. Hemoglobin [Change from Baseline Hemoglobin at 4 months after discharge]

    g/dL

  6. Hemoglobin [Change from Baseline Hemoglobin at 12 months after discharge]

    g/dL

  7. Leukocyte [Change from Baseline Leukocyte at 4 months after discharge]

    10^3/µL

  8. Leukocyte [Change from Baseline Leukocyte at 12 months after discharge]

    10^3/µL

  9. Thrombocyte [Change from Baseline Thrombocyte at 4 months after discharge]

    10^3/µL

  10. Thrombocyte [Change from Baseline Thrombocyte at 12 months after discharge]

    10^3/µL

  11. Blood Glucose [Change from Baseline Blood Glucose at 4 months after discharge]

    mg/dL

  12. Blood Glucose [Change from Baseline Blood Glucose at 12 months after discharge]

    mg/dL

  13. Sodium [Change from Baseline Sodium at 4 months after discharge]

    mEq/L

  14. Sodium [Change from Baseline Sodium at 12 months after discharge]

    mEq/L

  15. Potassium [Change from Baseline Sodium at 4 months after discharge]

    mEq/L

  16. Potassium [Change from Baseline Sodium at 12 months after discharge]

    mEq/L

  17. Calcium [Change from Baseline Sodium at 4 months after discharge]

    mEq/L

  18. Calcium [Change from Baseline Sodium at 12 months after discharge]

    mEq/L

  19. Serum Creatinine [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  20. Serum Creatinine [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  21. Total Bilirubin [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  22. Total Bilirubin [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  23. Indirect Bilirubin [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  24. Indirect Bilirubin [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  25. High-density lipoprotein (HDL) cholesterol [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  26. High-density lipoprotein (HDL) cholesterol [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  27. Low-density lipoprotein (LDL) cholesterol [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  28. Low-density lipoprotein (LDL) cholesterol [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  29. Aspartate Aminotransferase [Change from Baseline Sodium at 4 months after discharge]

    U/L

  30. Aspartate Aminotransferase [Change from Baseline Sodium at 12 months after discharge]

    U/L

  31. Alanine aminotransferase [Change from Baseline Sodium at 4 months after discharge]

    U/L

  32. Alanine aminotransferase [Change from Baseline Sodium at 12 months after discharge]

    U/L

  33. Alkaline Phosphatase [Change from Baseline Sodium at 4 months after discharge]

    U/L

  34. Alkaline Phosphatase [Change from Baseline Sodium at 12 months after discharge]

    U/L

  35. Triglyceride [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  36. Triglyceride [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  37. Total Cholesterol [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  38. Total Cholesterol [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

  39. Albumin [Change from Baseline Sodium at 4 months after discharge]

    g/dL

  40. Albumin [Change from Baseline Sodium at 12 months after discharge]

    g/dL

  41. glucose in urine [Change from Baseline Sodium at 4 months after discharge]

    mg/dL

  42. glucose in urine [Change from Baseline Sodium at 12 months after discharge]

    mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Izmir Turkey 35040

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
FATMA DEMIR KORKMAZ, Professor, Ege University
ClinicalTrials.gov Identifier:
NCT05003193
Other Study ID Numbers:
  • fatma.demir1
First Posted:
Aug 12, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FATMA DEMIR KORKMAZ, Professor, Ege University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021