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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week. |
|
| Control | Active Comparator | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialytic exercise training | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand test (STS60) | measured in number of repetitions in 60 seconds | 3 month |
| Timed-up-and-go test (TUG) | measured in time (seconds) | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass | measured in kg by bio-impedance analysis | 3 month |
| body fat mass | measured in kg by bio-impedance analysis | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Schiffer, Prof. | Universitätsklinikum Erlangen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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)
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|
| Control | Behavioral | Usual care |
|
| Quality of life by Kidney Disease Quality of Life Instrument (KDQOL) | 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) | 3 month |
| Fatigue by Fatigue Assessment Scale (FAS) | measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue) | 3 month |
| activity by Freiburg Questionnaire of physical activity | 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) | 3 month |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |