A pilot randomized controlled trial on the efficacy of neuromuscular electrical stimulation in combination with virtual reality-based distraction on muscle strenght of the quadriceps femoris muscle in haemodialysis patients

Not Applicable

• Conditions: N17-N19; Renal failure

• Registration Number: DRKS00029276
• Lead Sponsor: Klinikum rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Study Completion: 2022-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Age = 18 years
- Regular hemodialysis for > six months
- Adequate visual function with or without aids
- Signed informed consent document

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 <35%.
? Blood pressure >180 mm Hg before intervention.
? Pulse > 120/min before intervention

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the change in muscle strength of the M. quadriceps femoris due to neuromuscular electrical stimulation (NMES).<br>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 Outcome Measures

Name	Time	Method
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.<br><br>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)). <br><br>Blood samples are drawn from the patients at t0, t1/2 and t1 to measure the level of serum albumin level.<br><br>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.