Dialysis Exercise With a Bed Compatible Leg TRAiningstool

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial

Conditions
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Chronic Kidney Diseases, Hemodialysis

Intervention / Treatment
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* Behavioral: Intradialytic exercise training
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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).<br>|
| Active Comparator: Control<br>Usual Care | Behavioral: Control<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Intradialytic exercise, Hemodialysis training