SarcopeniaGERKONCT03767088
Whole-body Electromyostimulation in Inpatient Rehabilitation
A study testing WB-EMS and (synchronized) Training program without WB-EMS in people with Sarcopenia, run by Prof. Dr. Frank Mooren at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia
- What is being tested?
- WB-EMS and (synchronized) Training program without WB-EMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- skeletal muscle index (SMI) < 0,789 (men); < 0,512 (women)
- A general state of good health
- Medically approved unrestricted sports participation as shown by diagnostic performance test
- Willingness to provide signed informed consent
Who cannot join
- Post-coronary artery bypass graft (ACVB) surgery in the last 3 months
- Condition after pacemaker and defibrillator implantation
- renal insufficiency from stage 3a
- epilepsy
- feverish diseases or infectious diseases
- Taking medicines the affect muscle metabolism
- severe neurological disorders
- Skin injuries in the area of electrodes
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik Königsfeld der DRV
Ennepetal, North Rhine-Westphalia, 58256
About this study
Official title: Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial
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.
Read the 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:
- WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)
- partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)
- control, just performing the functional, mainly eccentric motion pattern without stimulation
- Conditions
- Sarcopenia
- Being tested
- WB-EMS, (synchronized) Training program without WB-EMS
- Keywords
- WB-EMS, rehabilitation, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-EMSDevice
whole body electromyostimulation
(synchronized) Training program without WB-EMSOther
20 min of pronounced eccentric movement patterns
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS | Active comparator | 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 Receives: Device: WB-EMS |
| partial WB-EMS | Active comparator | 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 Receives: Device: WB-EMS |
| control | Sham comparator | 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 Receives: Other: (synchronized) Training program without WB-EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
(isometric) muscle strength of arms, legs and trunk (extenstion)
isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)
Measured: 4 weeks
muscle function
chair rise test [repetitions; n]
Measured: 4 weeks
muscle function / submaximal performance test
6 minute walking test [distance; m]
Measured: 4 weeks
Secondary outcomes (16)
muscle mass via multifrequency bioimpedance analysis
via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
Measured: 4 weeks
body fat via multifrequency bioimpedance analysis
via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
Measured: 4 weeks
blood-sample: triglycerides
blood-sample
Measured: 4 weeks
blood-sample: high-density lipoprotein (HDL)
blood-sample
Measured: 4 weeks
blood-sample: low-density lipoprotein (LDL)
blood-sample
Measured: 4 weeks
blood-sample: Crea/glomerular filtration rate (GfR)
blood-sample
Measured: 4 weeks
blood-sample: glutamate oxaloacetate transaminase (GOT)
blood-sample
Measured: 4 weeks
blood-sample: glutamic pyruvic transaminase (GPT)
blood-sample
Measured: 4 weeks
blood-sample: gamma-glutamyl transpeptidase (GGT)
blood-sample
Measured: 4 weeks
blood-sample: creatine kinase (CK)
blood-sample
Measured: 4 weeks
blood-sample: myoglobin
blood-sample
Measured: 4 weeks
blood-sample: sodium
blood-sample
Measured: 4 weeks
potassium
blood-sample
Measured: 4 weeks
life quality
questionnaire: Short Form 36 Health Survey (SF-36)
Measured: 4 weeks
self-efficacy
questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Measured: 4 weeks
activities of daily living
questionnaire: Late-Life Function \& Disability Instrument (LLFDI)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jan 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled parallel group design
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Frank Mooren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Frank Mooren, University of Witten/Herdecke
- Investigators
- Frank C Mooren, Prof, Principal investigator, Department of Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767088
- Sponsor's protocol ID
- UWittenHerdecke
- Acronym
- GERKO
- Status last verified
- May 2021
- First submitted
- 4 Dec 2018
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03767088
- Acronym / sponsor ID
- GERKO / UWittenHerdecke
- Conditions
- Sarcopenia
- Keywords
- WB-EMS, rehabilitation, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Prof. Dr. Frank MoorenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)
- partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)
- control, just performing the functional, mainly eccentric motion pattern without stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective randomized controlled parallel group design
| Arm | Type | Receives |
|---|---|---|
| WB-EMS | Active comparator | Device: WB-EMS1.5 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 |
| partial WB-EMS | Active comparator | Device: WB-EMS1.5 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 |
| control | Sham comparator | Other: (synchronized) Training program without WB-EMSactive 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- skeletal muscle index (SMI) < 0,789 (men); < 0,512 (women)
- A general state of good health
- Medically approved unrestricted sports participation as shown by diagnostic performance test
- Willingness to provide signed informed consent
Key exclusion criteria (8 listed)
- Post-coronary artery bypass graft (ACVB) surgery in the last 3 months
- Condition after pacemaker and defibrillator implantation
- renal insufficiency from stage 3a
- epilepsy
- feverish diseases or infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB-EMSwhole body electromyostimulation | Device | WB-EMS, partial WB-EMS |
| (synchronized) Training program without WB-EMS20 min of pronounced eccentric movement patterns | Other | control |
Primary outcome
(isometric) muscle strength of arms, legs and trunk (extenstion)
Time frame: 4 weeks
isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)
muscle function
Time frame: 4 weeks
chair rise test [repetitions; n]
muscle function / submaximal performance test
Time frame: 4 weeks
6 minute walking test [distance; m]
16 secondary outcomes
muscle mass via multifrequency bioimpedance analysis
Time frame: 4 weeks
body fat via multifrequency bioimpedance analysis
Time frame: 4 weeks
blood-sample: triglycerides
Time frame: 4 weeks
blood-sample: high-density lipoprotein (HDL)
Time frame: 4 weeks
blood-sample: low-density lipoprotein (LDL)
Time frame: 4 weeks
blood-sample: Crea/glomerular filtration rate (GfR)
Time frame: 4 weeks
blood-sample: glutamate oxaloacetate transaminase (GOT)
Time frame: 4 weeks
blood-sample: glutamic pyruvic transaminase (GPT)
Time frame: 4 weeks
blood-sample: gamma-glutamyl transpeptidase (GGT)
Time frame: 4 weeks
blood-sample: creatine kinase (CK)
Time frame: 4 weeks
blood-sample: myoglobin
Time frame: 4 weeks
blood-sample: sodium
Time frame: 4 weeks
potassium
Time frame: 4 weeks
life quality
Time frame: 4 weeks
self-efficacy
Time frame: 4 weeks
activities of daily living
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank C Mooren, Prof principal investigator
Department of Rehabilitation Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-EMS and (synchronized) Training program without WB-EMS in people with Sarcopenia, run by Prof. Dr. Frank Mooren at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(isometric) muscle strength of arms, legs and trunk (extenstion) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.