N17-N19
Conditions
Interventions
Group 1: Patients in this group are provided with standard haemodialysis care and neuromuscular electrical stimulation (20 or 30 min.) on the quadriceps femoris muscle two or three times per week duri
Sponsors
Klinikum rechts der Isar der TU München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Regular hemodialysis for > six months - Adequate visual function with or without aids - Signed informed consent document
Exclusion criteria
Exclusion criteria: Relative exclusion criteria: ? All skin diseases ? Chronic pain conditions that have not been clarified, regardless of body region ? all sensitivity disorders with reduced pain sensation ? newly diagnosed diabetes mellitus or uncertain metabolic situation ? Application of electrodes in the area of tumor diseases ?current ongoing chemotherapies. Absolute exclusion criteria: ? Patient does not meet all of the above inclusion criteria. ?no informed consent to participate in the study or limitations to give consent ? sensitivity to nausea or dizziness (so-called "motion sickness") ? potassium level > 7 mmol/l before intervention. ? Acute diseases of the gastrointestinal tract ? Acute communicable diseases (e.g., influenza or colds) ? High fever (e.g., > 39°C). ? Alcohol and/or drug addiction (EMS not after alcohol consumption). ? Increased risk of thrombosis (e.g., pregnancy). ? Known dementia syndrome Pre-existing conditions with increased risk of dizziness (e.g., epilepsy, etc.) ? Electrical implants (e.g., cardiac pacemaker) ? Metallic implants in the treatment area (target muscle Mqf) (attachment of electrodes not on metal) ? Insulin pump users ? Acute or recent cardiac arrhythmia or other cardiac excitation and conduction disorders ? Severe cardiac disease with an ejection fraction 180 mm Hg before intervention. ? Pulse > 120/min before intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the change in muscle strength of the M. quadriceps femoris due to neuromuscular electrical stimulation (NMES). To assess the changes of the study intervention, the muscle strength of the M. quadriceps femoris will be measured in kilogram-force using a dynamometer before and after the 12 study weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure changes due to the study intervention, body compositions (BMI, weight, muscle, fat, water percentage) will be measured using a scale, muscle mass of the quadriceps femoris muscle will be measured using a circumference measurement of the thigh and muscle functional capacity will be measured using the 1-Minute-Sit-to-Stand-up-Test before and after the 12 study weeks. In addition, quality of life, depressive states, acceptance and NMES-related discomfort, if any, will be evaluated by questionnaires (Kidney Disease Quality of Life Instrument (KDQOL), Allgemeine Depressionsskala (ADS), Visual Analog Scale (VAS)). Blood samples are drawn from the patients at t0, t1/2 and t1 to measure the level of serum albumin level. Aspects of the exploratory review, costs during the study period, feasibility/acceptability, and safety (number of adverse events) will be recorded by documentation throughout the study period. | — |
Countries
Germany
Contacts
Public ContactLiya Hannemann
Klinikum rechts der Isar
Outcome results
None listed