DEXTRA: Dialysis Exercise With a Bed Compatible Leg TRAiningstool
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week. |
Behavioral: Intradialytic 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).
|
| Active Comparator: Control Usual Care |
Behavioral: Control
Usual care
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- muscle mass [3 month]
measured in kg by bio-impedance analysis
- body fat mass [3 month]
measured in kg by bio-impedance analysis
- 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)
- 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)
- 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)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Erlangen | Erlangen | Bavaria | Germany | 91054 |
Sponsors and Collaborators
- University of Erlangen-Nürnberg Medical School
Investigators
- Study Director: Mario Schiffer, Prof., Universitätsklinikum Erlangen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-40-B