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Exercise Training and Physical Rehabilitation in Patients With Chronic Kidney Disease in Europe - What is the Problem? (EUSUREX)

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ClinicalTrials.gov Identifier: NCT03923972
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
Cardenal Herrera University
Aristotle University Of Thessaloniki
Queen Margaret University
Universiteit Antwerpen
Tartu University Hospital
University of Pisa
King's College London
Sozialstiftung Bamberg
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Information provided by (Responsible Party):
Naomi Clyne, Skane University Hospital

Brief Summary:
This study evaluates possible barriers to physical activity/exercise training for patients with chronic kidney disease in Europe. The study's aim is to investigate structural problems and attitudes at different levels of care. Both a systemic and individual approach are applied. Barriers due to health care organisation and reimbursement policies will be investigated in the health care system and at the renal unit. Perceived benefits of physical activity and personal attitudes towards a healthy lifestyle will be investigated in nephrologists and renal nurses. Patients' health related quality of life, attitudes and perceived availability will be explored.

Condition or disease
Renal Insufficiency, Chronic Kidney Failure, Chronic Exercise

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Exercise Training and Physical Rehabilitation in Patients With Chronic Kidney Disease in Europe - What is the Problem? - A European Survey Study
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with chronic kidney disease
Patients with non dialysis dependent chronic kidney disease stages 4-5, patients on renal replacement therapy treated with peritoneal dialysis or hemodialysis, patients after renal transplantation
Nephrologists
physicians treating patients with chronic kidney disease
Nephrology nurses
nurses caring for patients with chronic kidney disease
heads of Nephrology departments
Medical and/or administrative directors of e nephrology department with knowledge of the healthcare system in their country



Primary Outcome Measures :
  1. Exercise prescription to patients with chronic kidney disease [ Time Frame: through study completion, an average of one year ]
    Number of units with exercise prescription plans

  2. Nephrologists exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of nephrologists participating in regular exercise

  3. Renal nurses exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of renal nurses participating in regular exercise

  4. CKD patients exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of patients who have received prescription of exercise training

  5. Health related quality of life in patients with CKD [ Time Frame: through study completion, an average of one year ]
    SF-36 quality of life questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic kidney disease comprising non dialysis dependent patients with stages 4-5, patients on peritoneal or hemodialysis, after a renal transplantation, physicians and nurses involved in the treatment of these patients and the director responsible for managing the nephrology department.
Criteria

Inclusion Criteria:

  • all adult patients with non-dialysis dependent chronic kidney disease, peritoneal dialysis, hemodialysis, renal transplantation
  • all active physicians in the department of nephrology involved in patient care
  • all active nurses in the department of nephrology involved in patient care
  • all heads of nephrology departments

Exclusion Criteria:

  • children
  • no physical disability making it impossible to conduct exercise training
  • no mental disability or language problem making it impossible to understand and fill in a questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923972


Contacts
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Contact: Naomi Clyne, MD, PhD 00464617 1682 Naomi.Clyne@med.lu.se
Contact: Evangelia Kouidi, MD, PhD ekouidi@med.auth.gr

Sponsors and Collaborators
Skane University Hospital
Cardenal Herrera University
Aristotle University Of Thessaloniki
Queen Margaret University
Universiteit Antwerpen
Tartu University Hospital
University of Pisa
King's College London
Sozialstiftung Bamberg
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Investigators
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Study Chair: Carmine Zoccali, MD, PhD CNR-IFC Clinical epidemiology of renal diseases and hypertension, Reggio Cal.
Study Chair: Naomi Clyne, MD, PhD Clinical Sciences, Lund, Lund University and Skåne University Hospital
Principal Investigator: Carmine Zoccali, MD, PhD CNR-IFC Clinical epidemiology of renal diseases and hypertension
Principal Investigator: Francesca Malamacci, MD, PhD Azienda Ospedaliera Bianchi-Melacrino-Morelli di Reggio Calabria
Principal Investigator: Naomi Clyne, MD, PhD Clinical Sciences, Lund, Lund University and Skåne University Hospital
Principal Investigator: Evangelia Kouidi, MD, PhD Aristotle University Of Thessaloniki
Principal Investigator: Sharlene Greenwood, PhD King's College London
Principal Investigator: Amaryllis VanCraenenbroeck, MD, PhD Universiteit Antwerpen
Principal Investigator: Adamasco Cupisti, MD, PhD University of Pisa
Principal Investigator: Pelagia Koufaki, PhD Queen Margaret University
Principal Investigator: Eva Segura Orti, PhD Cardenal Herrera University
Principal Investigator: Clemens Grupp, MD, PhD Sozialstiftung Bamberg
Principal Investigator: Mai Rosenberg, MD, PhD University of Tarttu
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Responsible Party: Naomi Clyne, associate professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT03923972    
Other Study ID Numbers: EUSUREX-01
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naomi Clyne, Skane University Hospital:
physical activity
exercise training
surveys and questionnaires
chronic kidney disease
dialysis
kidney transplantation
health care facilities
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases