The primary objective of the study is to assess the longitudinal effects of differences and changes in renal function at CKD stage 3-5 on physical functioning. The secondary objectives of the study are to assess the longitudinal effects of…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to assess the longitudinal effects of
differences and changes in renal function at CKD stage 3-5 on physical
functioning.
Secondary outcome
The secondary objectives of the study are to assess the longitudinal effects of
differences and changes in renal function at CKD stage 3-5 on physical
activity, nutritional status, cardiovascular function, quality of life, symptom
burden, illness perception, anxiety and depression.
Background summary
The number of patients with chronic kidney disease (CKD) and end-stage renal
disease is increasing rapidly worldwide. It is expected that the number of
patients with late-stage CKD (stage 4 and 5) will increase even further. These
prospects lead to an increasing necessity of predialysis care, not only to
delay a decline in renal function but also to prevent the loss of important
physical functions and quality of life in relation to physical frailty, which
were apparent in our previous studies in predialysis, as well as dialysis
patients. Earlier detection of these changes may facilitate early intervention
and prevention.
Study objective
The primary objective of the study is to assess the longitudinal effects of
differences and changes in renal function at CKD stage 3-5 on physical
functioning. The secondary objectives of the study are to assess the
longitudinal effects of differences and changes in renal function at CKD stage
3-5 on physical activity, nutritional status, cardiovascular function, quality
of life, symptom burden, illness perception, anxiety and depression. The third
objective is to assess the relation between different methods used to assess
body composition with muscle strength and physical activity.
Study design
This is a prospective longitudinal cohort study with a follow-up of 4 years.
All diagnostic techniques are non-invasive and provide minimal burden to the
patient. As a comparison, age matched healthy controls will also be included.
Study burden and risks
In this study, only non-invasive techniques will be used which pose a minimal
burden to the patient. Blood sampling will coincide as much as possible with
regular blood takings for clinical purposes. The study will not have direct
benefit for the participants. Bioimpedance measurements will not be taken in
patients with ICD or pacemaker.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Patients:
• The population consists of patients attending the predialysis out-patient
clinic, in which stage 3-5
CKD is diagnosed.
• Age> or equal to 18 years.
• Ability to provide written informed consent.,
Controls:
• Age> or equal to 18 years.
• Ability to provide written informed consent.
• If known with hypertension: well controlled bloodpressure (systolic <140mmHg
and/or diastolic <90mmHg) with the use of hypertensive medication
Exclusion criteria
Patients:
• Inability to provide informed consent
• Active symptomatic coronary artery disease or cardiac failure NYHA class III
or IV, whitin 3 months before inclusion
• Active malignancies, with a life expectancy of less then 1 year
• Active infections, whitin 3 months before inclusion
CKD after transplantation
• For bioimpedance measurements: presence of ICD or pacemaker. There are no
restrictions for other measurements in these patients.
Controls:
• Inability to provide informed consent
• Hypertension (with or without the use of hypertensive medication) with a
blood pressure higher than 160 mmHg systolic and/or diastolic larger than 100
mmHg during the screening.
• Diabetes Mellitus
• Self-reported cardiovascular disease / chronic kidney disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68518.068.18 |