The Effect of Walking in Kidney Transplant Patients

August 6, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Change from Baseline Blood Pressure at 4 months after discharge
mmHg
Change from Baseline Blood Pressure at 4 months after discharge
Blood Pressure
Time Frame: Change from Baseline Blood Pressure at 12 months after discharge
mmHg
Change from Baseline Blood Pressure at 12 months after discharge
Body Mass Index (BMI)
Time Frame: 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
Change from Baseline BMI at 4 months after discharge
Body Mass Index (BMI)
Time Frame: 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
Time Frame: Change from Baseline Hemoglobin at 4 months after discharge
g/dL
Change from Baseline Hemoglobin at 4 months after discharge
Hemoglobin
Time Frame: Change from Baseline Hemoglobin at 12 months after discharge
g/dL
Change from Baseline Hemoglobin at 12 months after discharge
Leukocyte
Time Frame: Change from Baseline Leukocyte at 4 months after discharge
10^3/µL
Change from Baseline Leukocyte at 4 months after discharge
Leukocyte
Time Frame: Change from Baseline Leukocyte at 12 months after discharge
10^3/µL
Change from Baseline Leukocyte at 12 months after discharge
Thrombocyte
Time Frame: Change from Baseline Thrombocyte at 4 months after discharge
10^3/µL
Change from Baseline Thrombocyte at 4 months after discharge
Thrombocyte
Time Frame: Change from Baseline Thrombocyte at 12 months after discharge
10^3/µL
Change from Baseline Thrombocyte at 12 months after discharge
Blood Glucose
Time Frame: Change from Baseline Blood Glucose at 4 months after discharge
mg/dL
Change from Baseline Blood Glucose at 4 months after discharge
Blood Glucose
Time Frame: Change from Baseline Blood Glucose at 12 months after discharge
mg/dL
Change from Baseline Blood Glucose at 12 months after discharge
Sodium
Time Frame: Change from Baseline Sodium at 4 months after discharge
mEq/L
Change from Baseline Sodium at 4 months after discharge
Sodium
Time Frame: Change from Baseline Sodium at 12 months after discharge
mEq/L
Change from Baseline Sodium at 12 months after discharge
Potassium
Time Frame: Change from Baseline Sodium at 4 months after discharge
mEq/L
Change from Baseline Sodium at 4 months after discharge
Potassium
Time Frame: Change from Baseline Sodium at 12 months after discharge
mEq/L
Change from Baseline Sodium at 12 months after discharge
Calcium
Time Frame: Change from Baseline Sodium at 4 months after discharge
mEq/L
Change from Baseline Sodium at 4 months after discharge
Calcium
Time Frame: Change from Baseline Sodium at 12 months after discharge
mEq/L
Change from Baseline Sodium at 12 months after discharge
Serum Creatinine
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Serum Creatinine
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Total Bilirubin
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Total Bilirubin
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Indirect Bilirubin
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Indirect Bilirubin
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
High-density lipoprotein (HDL) cholesterol
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
High-density lipoprotein (HDL) cholesterol
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Low-density lipoprotein (LDL) cholesterol
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Low-density lipoprotein (LDL) cholesterol
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Aspartate Aminotransferase
Time Frame: Change from Baseline Sodium at 4 months after discharge
U/L
Change from Baseline Sodium at 4 months after discharge
Aspartate Aminotransferase
Time Frame: Change from Baseline Sodium at 12 months after discharge
U/L
Change from Baseline Sodium at 12 months after discharge
Alanine aminotransferase
Time Frame: Change from Baseline Sodium at 4 months after discharge
U/L
Change from Baseline Sodium at 4 months after discharge
Alanine aminotransferase
Time Frame: Change from Baseline Sodium at 12 months after discharge
U/L
Change from Baseline Sodium at 12 months after discharge
Alkaline Phosphatase
Time Frame: Change from Baseline Sodium at 4 months after discharge
U/L
Change from Baseline Sodium at 4 months after discharge
Alkaline Phosphatase
Time Frame: Change from Baseline Sodium at 12 months after discharge
U/L
Change from Baseline Sodium at 12 months after discharge
Triglyceride
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Triglyceride
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Total Cholesterol
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
Total Cholesterol
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge
Albumin
Time Frame: Change from Baseline Sodium at 4 months after discharge
g/dL
Change from Baseline Sodium at 4 months after discharge
Albumin
Time Frame: Change from Baseline Sodium at 12 months after discharge
g/dL
Change from Baseline Sodium at 12 months after discharge
glucose in urine
Time Frame: Change from Baseline Sodium at 4 months after discharge
mg/dL
Change from Baseline Sodium at 4 months after discharge
glucose in urine
Time Frame: Change from Baseline Sodium at 12 months after discharge
mg/dL
Change from Baseline Sodium at 12 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fatma.demir1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings