Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03923972 |
| Other study ID # |
EUSUREX-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2019 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Skane University Hospital |
| Contact |
Naomi Clyne, MD, PhD |
| Phone |
00464617 1682 |
| Email |
Naomi.Clyne[@]med.lu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
