The Effect of Walking in Kidney Transplant Patients
6 de agosto de 2021 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
68
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Fatma DEMIR KORKMAZ, Professor
- Número de telefone: +902323115506
- E-mail: fatma.demir@ege.edu.tr
Estude backup de contato
- Nome: Tugba Nur ODEN, PhD Student
- Número de telefone: +902323905106
- E-mail: tugba.nur.zoturk@ege.edu.tr
Locais de estudo
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Izmir, Peru, 35040
- Recrutamento
- Ege university
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Contato:
- Fatma DEMIR KORKMAZ, Professor
- Número de telefone: +902323115506
- E-mail: fatma.demir@ege.edu.tr
-
Contato:
- Tugba Nur ODEN, PhD Student
- Número de telefone: +902323905106
- E-mail: tugba.nur.ozturk@ege.edu.tr
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood Pressure
Prazo: 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
Prazo: 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)
Prazo: 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
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Change from Baseline BMI at 4 months after discharge
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Body Mass Index (BMI)
Prazo: 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
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Change from Baseline BMI at 12 months after discharge
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|
Hemoglobin
Prazo: 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
|
|
Hemoglobin
Prazo: Change from Baseline Hemoglobin at 12 months after discharge
|
g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
|
|
Leukocyte
Prazo: Change from Baseline Leukocyte at 4 months after discharge
|
10^3/µL
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Change from Baseline Leukocyte at 4 months after discharge
|
|
Leukocyte
Prazo: Change from Baseline Leukocyte at 12 months after discharge
|
10^3/µL
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Change from Baseline Leukocyte at 12 months after discharge
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Thrombocyte
Prazo: 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
Prazo: 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
|
|
Blood Glucose
Prazo: Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
|
Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
Prazo: Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
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Change from Baseline Blood Glucose at 12 months after discharge
|
|
Sodium
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
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Change from Baseline Sodium at 4 months after discharge
|
|
Sodium
Prazo: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Potassium
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
Prazo: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
Prazo: Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Serum Creatinine
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Serum Creatinine
Prazo: 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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Total Bilirubin
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Total Bilirubin
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Low-density lipoprotein (LDL) cholesterol
Prazo: 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
Prazo: 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
|
|
Aspartate Aminotransferase
Prazo: 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
|
|
Aspartate Aminotransferase
Prazo: 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
Prazo: Change from Baseline Sodium at 4 months after discharge
|
U/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Alanine aminotransferase
Prazo: 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
|
|
Alkaline Phosphatase
Prazo: Change from Baseline Sodium at 4 months after discharge
|
U/L
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Change from Baseline Sodium at 4 months after discharge
|
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Alkaline Phosphatase
Prazo: Change from Baseline Sodium at 12 months after discharge
|
U/L
|
Change from Baseline Sodium at 12 months after discharge
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Triglyceride
Prazo: 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
Prazo: 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
Prazo: Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Total Cholesterol
Prazo: 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
Prazo: Change from Baseline Sodium at 4 months after discharge
|
g/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Albumin
Prazo: 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
Prazo: 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
Prazo: Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Fatma DEMIR KORKMAZ, Professor, Ege University Faculty of Nursing 35000, Izmir, Turkey
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de novembro de 2020
Conclusão Primária (Antecipado)
1 de novembro de 2022
Conclusão do estudo (Antecipado)
1 de novembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
30 de março de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de agosto de 2021
Primeira postagem (Real)
12 de agosto de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de agosto de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de agosto de 2021
Última verificação
1 de agosto de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- fatma.demir1
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .