Chronic Kidney Diseases, Hemodialysis
Conditions
Keywords
Dialysis, Intradialytic exercise, Hemodialysis training
Brief summary
This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.
Detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.
Interventions
BEHAVIORALIntradialytic exercise training
The patients in the intervention group will receive 3 months of endurance training, 2x/week for 30 min. 5 min of this should be a warm-up, 20 min of exertion and 5 min of cool down. The warm-up and cool-down should be equivalent to a very light load (Borg scale 9), whereas the exertion phase should be exhausting for the patients (Borg scale 14-15).
BEHAVIORALControl
Usual care
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years * Patients who started dialysis more than 3 months ago * Patients must be mentally and physically able to participate in exercise
Exclusion criteria
* Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand test (STS60) | 3 month | measured in number of repetitions in 60 seconds |
| Timed-up-and-go test (TUG) | 3 month | measured in time (seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life by Kidney Disease Quality of Life Instrument (KDQOL) | 3 month | measured in change of scale by questionnaire (higher Score = better health; Questions are combined to form items and the average is calculated; Range from 0-100) |
| muscle mass | 3 month | measured in kg by bio-impedance analysis |
| activity by Freiburg Questionnaire of physical activity | 3 month | measured in change of scale by questionnaire (The higher the score, the more active the participant. the lowest level would be a score of 0) |
| Fatigue by Fatigue Assessment Scale (FAS) | 3 month | measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue) |
| body fat mass | 3 month | measured in kg by bio-impedance analysis |
Countries
Germany
Outcome results
None listed