The Effect of Walking in Kidney Transplant Patients
2021년 8월 6일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
68
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Fatma DEMIR KORKMAZ, Professor
- 전화번호: +902323115506
- 이메일: fatma.demir@ege.edu.tr
연구 연락처 백업
- 이름: Tugba Nur ODEN, PhD Student
- 전화번호: +902323905106
- 이메일: tugba.nur.zoturk@ege.edu.tr
연구 장소
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Izmir, 칠면조, 35040
- 모병
- Ege university
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연락하다:
- Fatma DEMIR KORKMAZ, Professor
- 전화번호: +902323115506
- 이메일: fatma.demir@ege.edu.tr
-
연락하다:
- Tugba Nur ODEN, PhD Student
- 전화번호: +902323905106
- 이메일: tugba.nur.ozturk@ege.edu.tr
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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2000 steps per day in 20 minutes for 90 days, guided by a pedometer after a kidney transplantation
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Pressure
기간: Change from Baseline Blood Pressure at 4 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 4 months after discharge
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Blood Pressure
기간: Change from Baseline Blood Pressure at 12 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 12 months after discharge
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Body Mass Index (BMI)
기간: Change from Baseline BMI at 4 months after discharge
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BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 4 months after discharge
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Body Mass Index (BMI)
기간: Change from Baseline BMI at 12 months after discharge
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BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 12 months after discharge
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Hemoglobin
기간: Change from Baseline Hemoglobin at 4 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 4 months after discharge
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Hemoglobin
기간: Change from Baseline Hemoglobin at 12 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
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Leukocyte
기간: Change from Baseline Leukocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 4 months after discharge
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Leukocyte
기간: Change from Baseline Leukocyte at 12 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 12 months after discharge
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Thrombocyte
기간: Change from Baseline Thrombocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Thrombocyte at 4 months after discharge
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Thrombocyte
기간: Change from Baseline Thrombocyte at 12 months after discharge
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10^3/µL
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Change from Baseline Thrombocyte at 12 months after discharge
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Blood Glucose
기간: Change from Baseline Blood Glucose at 4 months after discharge
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mg/dL
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Change from Baseline Blood Glucose at 4 months after discharge
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Blood Glucose
기간: Change from Baseline Blood Glucose at 12 months after discharge
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mg/dL
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Change from Baseline Blood Glucose at 12 months after discharge
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Sodium
기간: Change from Baseline Sodium at 4 months after discharge
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mEq/L
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Change from Baseline Sodium at 4 months after discharge
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Sodium
기간: Change from Baseline Sodium at 12 months after discharge
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mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
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Potassium
기간: Change from Baseline Sodium at 4 months after discharge
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mEq/L
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Change from Baseline Sodium at 4 months after discharge
|
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Potassium
기간: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
기간: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
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Change from Baseline Sodium at 4 months after discharge
|
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Calcium
기간: Change from Baseline Sodium at 12 months after discharge
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mEq/L
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Change from Baseline Sodium at 12 months after discharge
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Serum Creatinine
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Serum Creatinine
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Total Bilirubin
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Bilirubin
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Indirect Bilirubin
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Indirect Bilirubin
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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High-density lipoprotein (HDL) cholesterol
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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High-density lipoprotein (HDL) cholesterol
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Low-density lipoprotein (LDL) cholesterol
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Low-density lipoprotein (LDL) cholesterol
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Aspartate Aminotransferase
기간: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Aspartate Aminotransferase
기간: Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
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Alanine aminotransferase
기간: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Alanine aminotransferase
기간: Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
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Alkaline Phosphatase
기간: Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Alkaline Phosphatase
기간: Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
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Triglyceride
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Triglyceride
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Total Cholesterol
기간: Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Cholesterol
기간: Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Albumin
기간: Change from Baseline Sodium at 4 months after discharge
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g/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Albumin
기간: Change from Baseline Sodium at 12 months after discharge
|
g/dL
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Change from Baseline Sodium at 12 months after discharge
|
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glucose in urine
기간: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
기간: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- Aakhus S, Dahl K, Widerøe 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.
- 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.
- Berben L, Engberg SJ, Rossmeissl A, Gordon EJ, Kugler C, Schmidt-Trucksäss 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.
- 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.
- 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.
- 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.
- Svensson M, Jardine A, Fellström 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. Review.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 11월 19일
기본 완료 (예상)
2022년 11월 1일
연구 완료 (예상)
2022년 11월 1일
연구 등록 날짜
최초 제출
2021년 3월 30일
QC 기준을 충족하는 최초 제출
2021년 8월 6일
처음 게시됨 (실제)
2021년 8월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 6일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .