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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

Tracking Information
First Submitted Date March 12, 2019
First Posted Date April 23, 2019
Last Update Posted Date April 23, 2019
Estimated Study Start Date May 15, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2019)
  • 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
  • Nephrologists exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of nephrologists participating in regular exercise
  • Renal nurses exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of renal nurses participating in regular exercise
  • CKD patients exercise habits [ Time Frame: through study completion, an average of one year ]
    Number of patients who have received prescription of exercise training
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exercise Training and Physical Rehabilitation in Patients With Chronic Kidney Disease in Europe - What is the Problem?
Official Title Exercise Training and Physical Rehabilitation in Patients With Chronic Kidney Disease in Europe - What is the Problem? - A European Survey Study
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.
Detailed Description

Exercise training and physical rehabilitation in patients with chronic kidney disease in Europe - what is the problem? - A European survey study -EUSUREX (EUropean SUrvey on Renal EXercise)

Purpose Firstly, to identify potential barriers for integrating exercise training into regular therapy for patients with chronic kidney disease in different European countries.

Secondly, to use this knowledge of the importance of different barriers to promote the use of exercise training as therapy and to target the respective levels.

Thirdly, if there are obvious differences at the level of the health care system, positive examples from one country could be used as a lever in another country.

Background Lack of physical activity is common in patients with chronic kidney disease (CKD) and is a risk factor for increased mortality (1) as in the general population (2). To date there is a body of scientific evidence showing that patients with nondialysis dependent CKD, patients on maintenance dialysis and patients after renal transplantation all benefit from regular exercise training (3,4).

Many national societies worldwide recommend that exercise training be incorporated into treatment of patients with CKD. A number of qualitative and quantitative studies have highlighted various barriers to exercise training (5-12). The most commonly described barriers include patient hesitation due to feeling tired, not having time, being in pain or just being afraid to move. Other common barriers are staff related. Nurses are pressed for time and do not feel they have knowledge or competence to assist patients. Nephrologists do not ask patients about their physical activity or just do not think it is important. Some studies, albeit in general practitioners and cardiologists, have shown an association between the physicians' own level of physical activity and propensity to recommend physical activity to their patients. In a pilot study, the investigators found association between both renal physicians and nurses levels of physical activity and propensity to recommend physical training to their patients with chronic kidney disease (13).

No study has to date described possible barriers due to the health care system. These could be caused by the remuneration system, traditions pertaining to employing dedicated and specially trained physiotherapists or exercise physiologists or other causes.

There is to the investigators' knowledge no study employing a European perspective and investigating patients', physicians', nursing staff's and hospital administrators' attitudes and perception of barriers to integrating regular exercise training into routine clinical care. Nor is there any study examining the whole spectrum of chronic kidney disease, i.e comprising nondialysis dependent CKD, maintenance dialysis treatment, including both patients treated with hemodialysis and peritoneal dialysis, and after renal transplantation.

Methods Selection of participating centres with research subjects and patients A list of all Renal units for each country was sent to professor Carmine Zoccali's group with headquarters in Reggio di Calabria, where dr Giovanni Tripepi, head biostatistician of the CNR-IFC Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension Unit, randomly selected one renal unit per 4 million inhabitants.

The investigators aim is to include at least 1000 patients. If the investigators do not receive a sufficient number of replies from the patients from the centres the investigators have already contacted (all randomly selected), the investigators will make another random selection in the various countries and involve (just for the Patient questionnaire) other centres.

Construction of the questionnaires Step 1. National experts interested in the field of exercise training in patients with CKD were consulted.

Step 2. Current literature, pre-existing questionnaires and general experiences and suggestions received by various colleagues were collected and formed a basis for constructing the questionnaires.

Step 3. Five questionnaires were constructed targeting country level organization of physical rehabilitation programs as well as clinicians', nurses' and patients' perception about physical exercise and physical rehabilitation programmes.

  1. Country level questionnaire - general questions about physical rehabilitation opportunities at country level,
  2. Renal unit level questionnaire - questions about physical rehabilitation programs at the renal unit level,
  3. Nephrologist questionnaire - questions about how the problem is perceived by clinicians
  4. Nurse questionnaire - questions about how the problem is perceived by nurses
  5. Patient questionnaire - the SF-36 was used with added questions about how the problem is perceived by the patients.

Step 4 Questionnaires were validated for clarity and consistency of content in randomly selected units in EU countries.

Validation questions were constructed for each questionnaire. Each participating country has one or two national leaders responsible for the study.

The national leaders sent the questionnaires 2, 3 and 4 together with corresponding validation questionnaires to the heads of the randomly selected Renal units in their respective countries for validation by the head of the unit, the physicians and head nurse(s). Questionnaires 1 and 5 were validated by each country's national leader.

Step 5 After validation the questionnaires were once again sent to the national leaders for distribution to each country's randomly selected renal centres for a new evaluation to ensure that the questionnaires are clear and are consistent with content. Further refinements if necessary will be performed after which the final step of validation is completed. Finally, each national leader will translate the appropriate questionnaires as deemed necessary. The SF-36 is translated and validated in most European languages. The national leader will only need to translate the additional questions.

Distribution of questionnaires Once the questionnaires have been validated and unanimously approved, the colleagues at the various centres involved in the validation process (all randomly selected) will be asked to compile the VALIDATED Country-, Renal Unit-, Clinician-, Nurse- questionnaires and administer the Patient questionnaire to the whole (consenting) patient population at their respective centres.

Statistical evaluation The questionnaires will be sent to CNR-IFC Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension Unit in Reggio di Calabria for statistical evaluation. Data description and data analysis will be performed with parametric and non-parametric methods recommended for the analysis of questionnaires (14) by the STATA 15 statistical package.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic
  • Exercise
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 22, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Naomi Clyne, MD, PhD 00464617 1682 Naomi.Clyne@med.lu.se
Contact: Evangelia Kouidi, MD, PhD ekouidi@med.auth.gr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923972
Other Study ID Numbers EUSUREX-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Naomi Clyne, Skane University Hospital
Study Sponsor Skane University Hospital
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
Investigators
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
PRS Account Skane University Hospital
Verification Date April 2019