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

• ClinicalTrials.gov Identifier: NCT03923972
• Recruitment Status: Not yet recruiting
• First Posted: April 23, 2019
• Last Update Posted: April 23, 2019
• 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
• 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

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

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