Whole-body Electromyostimulation in Inpatient Rehabilitation

Sarcopenia Clinical Trial

— GERKO  

Official title:

Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767088
• Other study ID #: UWittenHerdecke
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2021
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on various studies, scientific evidence has proven the effectiveness of whole-body electromyostimulation (WB-EMS) on parameters such as increased physiological performance and body composition.

As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as part of the inpatient four-week rehabilitation of sarcopenic subjects.

Description:

The loss of muscle mass in the age-associated process (sarcopenia) is a common indication in the field of orthopedic and cardiac rehabilitation, which may also be reinforced by previous immobilization and disuse of the muscles (atrophy of muscle). Sarcopenia is defined as 2 standard deviations of average of the same sex in middle adult life. The present project focuses on the sarcopenia definition of the Foundation for the National Institutes of Health (FNIH). Their limits are < 0.789 (men) and < 0.512 (women) and are calculated by adding the absolute muscle mass of the extremities divided by the body mass index (BMI).

Due to reduced muscle mass and thus limited strength / performance, the implementation of conventional training tools with regard to generate corresponding intensities is no longer possible, or in persons with additional cardiac or orthopedic restrictions heavily limited.

In view of the existing indications, the alternative training technology whole-body electromyostimulation (WB-EMS) is an adequate training tool for the rehabilitation process. The time-saving (max 20 minutes per training session) and effective training method is characterized by low orthopedic and cardiac stress. Thus, WB-EMS combines both relevant aspects of a joint-friendly training with effects on muscle mass and functionality. Through the simultaneous activation of up to 10 muscle regions with corresponding, subjectively decidedly adjustable intensity per muscle group, up to 2,800 cm2 can be addressed. Synchronized to a motion video, the participants perform light physical exercises in parallel to the current pulses.

The aim of the study is, to evaluate the effect of additional WB-EMS during a 4-week period of inpatient rehabilitation, comparing 3 groups:

1. WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)

2. partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)

3. control, just performing the functional, mainly eccentric motion pattern without stimulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. skeletal muscle index (SMI) < 0,789 (men); < 0,512 (women)

2. A general state of good health

3. Medically approved unrestricted sports participation as shown by diagnostic performance test

4. Willingness to provide signed informed consent

Exclusion Criteria:

1. Post-coronary artery bypass graft (ACVB) surgery in the last 3 months

2. Condition after pacemaker and defibrillator implantation

3. renal insufficiency from stage 3a

4. epilepsy

5. feverish diseases or infectious diseases

6. Taking medicines the affect muscle metabolism

7. severe neurological disorders

8. Skin injuries in the area of electrodes

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Device:
• WB-EMS
whole body electromyostimulation

Other:
• (synchronized) Training program without WB-EMS
20 min of pronounced eccentric movement patterns

Locations

Country	Name	City	State
Germany	Klinik Königsfeld der DRV	Ennepetal	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Frank Mooren

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(isometric) muscle strength of arms, legs and trunk (extenstion)	isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)	4 weeks
Primary	muscle function	chair rise test [repetitions; n]	4 weeks
Primary	muscle function / submaximal performance test	6 minute walking test [distance; m]	4 weeks
Secondary	muscle mass via multifrequency bioimpedance analysis	via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)	4 weeks
Secondary	body fat via multifrequency bioimpedance analysis	via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)	4 weeks
Secondary	blood-sample: triglycerides	blood-sample	4 weeks
Secondary	blood-sample: high-density lipoprotein (HDL)	blood-sample	4 weeks
Secondary	blood-sample: low-density lipoprotein (LDL)	blood-sample	4 weeks
Secondary	blood-sample: Crea/glomerular filtration rate (GfR)	blood-sample	4 weeks
Secondary	blood-sample: glutamate oxaloacetate transaminase (GOT)	blood-sample	4 weeks
Secondary	blood-sample: glutamic pyruvic transaminase (GPT)	blood-sample	4 weeks
Secondary	blood-sample: gamma-glutamyl transpeptidase (GGT)	blood-sample	4 weeks
Secondary	blood-sample: creatine kinase (CK)	blood-sample	4 weeks
Secondary	blood-sample: myoglobin	blood-sample	4 weeks
Secondary	blood-sample: sodium	blood-sample	4 weeks
Secondary	potassium	blood-sample	4 weeks
Secondary	life quality	questionnaire: Short Form 36 Health Survey (SF-36)	4 weeks
Secondary	self-efficacy	questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)	4 weeks
Secondary	activities of daily living	questionnaire: Late-Life Function & Disability Instrument (LLFDI)	4 weeks