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临床试验/NCT05003193
NCT05003193Unknown不适用

The Effect of Pedometer Assisted Walking on Physical Activity Level and Metabolic Parameters in Patients With Renal Transplantation

Ege University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Blood Pressure

时间窗: Change from Baseline Blood Pressure at 12 months after discharge

mmHg

Hemoglobin

时间窗: Change from Baseline Hemoglobin at 12 months after discharge

g/dL

Indirect Bilirubin

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Alkaline Phosphatase

时间窗: Change from Baseline Sodium at 12 months after discharge

U/L

Body Mass Index (BMI)

时间窗: 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

Leukocyte

时间窗: Change from Baseline Leukocyte at 12 months after discharge

10\^3/µL

Sodium

时间窗: Change from Baseline Sodium at 12 months after discharge

mEq/L

Aspartate Aminotransferase

时间窗: Change from Baseline Sodium at 12 months after discharge

U/L

glucose in urine

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Alanine aminotransferase

时间窗: Change from Baseline Sodium at 12 months after discharge

U/L

Thrombocyte

时间窗: Change from Baseline Thrombocyte at 12 months after discharge

10\^3/µL

Blood Glucose

时间窗: Change from Baseline Blood Glucose at 12 months after discharge

mg/dL

Potassium

时间窗: Change from Baseline Sodium at 12 months after discharge

mEq/L

Triglyceride

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Total Cholesterol

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Serum Creatinine

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Total Bilirubin

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Calcium

时间窗: Change from Baseline Sodium at 12 months after discharge

mEq/L

High-density lipoprotein (HDL) cholesterol

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Low-density lipoprotein (LDL) cholesterol

时间窗: Change from Baseline Sodium at 12 months after discharge

mg/dL

Albumin

时间窗: Change from Baseline Sodium at 12 months after discharge

g/dL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

FATMA DEMIR KORKMAZ

Professor

Ege University

研究点 (2)

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