Clinical trial NCT03767088: Whole-body Electromyostimulation in Inpatient Rehabilitation
Official title: Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: WB-EMS
rehabilitation
sarcopenia
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled parallel group design
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: (isometric) muscle strength of arms, legs and trunk (extenstion)
timeFrame: 4 weeks
measure: muscle function
timeFrame: 4 weeks
measure: muscle function / submaximal performance test
timeFrame: 4 weeks
Secondary outcomes:
measure: muscle mass via multifrequency bioimpedance analysis
timeFrame: 4 weeks
measure: body fat via multifrequency bioimpedance analysis
timeFrame: 4 weeks
measure: blood-sample: triglycerides
timeFrame: 4 weeks
measure: blood-sample: high-density lipoprotein (HDL)
timeFrame: 4 weeks
measure: blood-sample: low-density lipoprotein (LDL)
timeFrame: 4 weeks
measure: blood-sample: Crea/glomerular filtration rate (GfR)
timeFrame: 4 weeks
measure: blood-sample: glutamate oxaloacetate transaminase (GOT)
timeFrame: 4 weeks
measure: blood-sample: glutamic pyruvic transaminase (GPT)
timeFrame: 4 weeks
measure: blood-sample: gamma-glutamyl transpeptidase (GGT)
timeFrame: 4 weeks
measure: blood-sample: creatine kinase (CK)
timeFrame: 4 weeks
measure: blood-sample: myoglobin
timeFrame: 4 weeks
measure: blood-sample: sodium
timeFrame: 4 weeks
measure: potassium
timeFrame: 4 weeks
measure: life quality
timeFrame: 4 weeks
measure: self-efficacy
timeFrame: 4 weeks
measure: activities of daily living
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ennepetal
country: Germany
facility: Klinik Königsfeld der DRV
state: NRW
Study officials:
affiliation: Department of Rehabilitation Science
name: Frank C Mooren, Prof
role: PRINCIPAL_INVESTIGATOR
References: