Clinical trial NCT03923972: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Insufficiency, Chronic
Kidney Failure, Chronic
Exercise
Keywords: physical activity
exercise training
surveys and questionnaires
chronic kidney disease
dialysis
kidney transplantation
health care facilities
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Cardenal Herrera University
name: Aristotle University Of Thessaloniki
name: Queen Margaret University
name: Universiteit Antwerpen
name: Tartu University Hospital
name: University of Pisa
name: King's College London
name: Sozialstiftung Bamberg
name: Azienda Ospedaliera Bianchi-Melacrino-Morelli
First posted: 2019-04-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Exercise prescription to patients with chronic kidney disease
timeFrame: through study completion, an average of one year
measure: Nephrologists exercise habits
timeFrame: through study completion, an average of one year
measure: Renal nurses exercise habits
timeFrame: through study completion, an average of one year
measure: CKD patients exercise habits
timeFrame: through study completion, an average of one year
measure: Health related quality of life in patients with CKD
timeFrame: through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Hallands sjukhus
city: Ljungby
country: Sweden
facility: Ljungby lasarett
Study officials:
affiliation: CNR-IFC Clinical epidemiology of renal diseases and hypertension, Reggio Cal.
name: Carmine Zoccali, MD, PhD
role: STUDY_CHAIR
affiliation: Clinical Sciences, Lund, Lund University and Skåne University Hospital
name: Naomi Clyne, MD, PhD
role: STUDY_CHAIR
affiliation: CNR-IFC Clinical epidemiology of renal diseases and hypertension
name: Carmine Zoccali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Bianchi-Melacrino-Morelli di Reggio Calabria
name: Francesca Malamacci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Sciences, Lund, Lund University and Skåne University Hospital
name: Naomi Clyne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University Of Thessaloniki
name: Evangelia Kouidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Amaryllis VanCraenenbroeck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pisa
name: Adamasco Cupisti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sozialstiftung Bamberg
name: Clemens Grupp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tarttu
name: Mai Rosenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: