Exercise Training and Physical Rehabilitation in Patients With Chronic Kidney Disease in Europe - What is the Problem?
NCT ID: NCT03923972
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1500 participants
OBSERVATIONAL
2019-05-15
2022-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
Nephrologists
physicians treating patients with chronic kidney disease
No interventions assigned to this group
Nephrology nurses
nurses caring for patients with chronic kidney disease
No interventions assigned to this group
heads of Nephrology departments
Medical and/or administrative directors of e nephrology department with knowledge of the healthcare system in their country
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardenal Herrera University
OTHER
Aristotle University Of Thessaloniki
OTHER
Queen Margaret University
OTHER
Universiteit Antwerpen
OTHER
Tartu University Hospital
OTHER
University of Pisa
OTHER
King's College London
OTHER
Sozialstiftung Bamberg
OTHER
Azienda Ospedaliera Bianchi-Melacrino-Morelli
OTHER
Skane University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Naomi Clyne
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carmine Zoccali, MD, PhD
Role: STUDY_CHAIR
CNR-IFC Clinical epidemiology of renal diseases and hypertension, Reggio Cal.
Naomi Clyne, MD, PhD
Role: STUDY_CHAIR
Clinical Sciences, Lund, Lund University and Skåne University Hospital
Carmine Zoccali, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CNR-IFC Clinical epidemiology of renal diseases and hypertension
Francesca Malamacci, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Bianchi-Melacrino-Morelli di Reggio Calabria
Naomi Clyne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Sciences, Lund, Lund University and Skåne University Hospital
Evangelia Kouidi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aristotle University Of Thessaloniki
Amaryllis VanCraenenbroeck, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Adamasco Cupisti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Clemens Grupp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sozialstiftung Bamberg
Mai Rosenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tarttu
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hallands sjukhus
Halmstad, , Sweden
Ljungby lasarett
Ljungby, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Karl Bjurstrom, MD
Role: primary
Lars Ekholm
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUSUREX-01
Identifier Type: -
Identifier Source: org_study_id