Whole-body Electromyostimulation in Inpatient Rehabilitation (GERKO)

Prof. Dr. Frank Mooren

Status: Completed

Conditions: Sarcopenia

Treatments: Device: WB-EMS; Other: (synchronized) Training program without WB-EMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03767088

UWittenHerdecke

Details and patient eligibility

About

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.

Full 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

Enrollment: 134 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 3 patient groups

WB-EMS

Active Comparator group

Description:

1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 8 muscle groups (legs, gluteal region, core, arms) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration

Treatment:

Device: WB-EMS

partial WB-EMS

Active Comparator group

Description:

1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 2 muscle groups (legs, gluteal region; lower extremities) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration

Treatment:

Device: WB-EMS

control

Sham Comparator group

Description:

active sham comparator: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session performing slight eccentric pronounced physiological movement patterns

Treatment:

Other: (synchronized) Training program without WB-EMS