HealthyNCT04499417
Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout
A study testing Electromyostimulation Whole-Body-Workout in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Electromyostimulation Whole-Body-Workout
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2020to Dec 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject familiarized with experimental procedure and had given written informed consent
- Able to understand German
- Reachability of participant for the eight training sessions
Who cannot join
- Contraindications for physical exercise or EMS-use
- Current EMS-use or intense regular exercise (> 60 min / week)
- Pregnancy
- Current presence of any mental disease
- Acute suicidality
- Substance dependencies with actual consumption (except nicotine)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Berlin, 10117
ems@charite.de
About this study
Official title: Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout
The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.
Read the detailed description
EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. Therefore EMS could lower the barrier to physical activity. The present study focusses on psychological and physical effects of an 8-week EMS workout. Physical activity is notably important for mental and physical health, but is on average far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological and physical effects through a less (subjective) cost-intense strength training.
- Conditions
- Healthy
- Being tested
- Electromyostimulation Whole-Body-Workout, Electromyostimulation Sham Whole-Body-Workout
- Keywords
- Physical Activity, Exercise, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyostimulation Whole-Body-WorkoutDevice
Also called EMS
Electromyostimulation - intensity 5 (muscle stimulation)
Electromyostimulation Sham Whole-Body-WorkoutDevice
Also called EMS-Sham
Electromyostimulation - intensity 0 (no muscle stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Condition | Experimental | 8 weeks x weekly 20 minutes whole-body-workouts with simultaneous muscle stimulation (EMS).
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity. Receives: Device: Electromyostimulation Whole-Body-Workout |
| Sham-Condition | Sham comparator | 8 weeks x weekly 20 minutes whole-body-workouts without simultaneous muscle stimulation (EMS).
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are not actually stimulated by EMS. Receives: Device: Electromyostimulation Sham Whole-Body-Workout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change of subjective well-being.
- Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).
Measured: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
Acute change of subjective relaxation.
- Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).
Measured: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
Change of acute symptoms of anxiety and depression.
- The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther \& Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.
Measured: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
Secondary outcomes (9)
Mid-/longterm changes in depressive symptoms.
- Patient Health Questionnaire (PHQ-9; Kroenke \& Spitzer, 2002). Sum scores ranging from 0 to 27, higher values indicate a worse outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in anxiety symptoms.
- Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006). Sum scores ranging from 0 to 21, higher values indicate a worse outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in affect-related psychological variables.
- The Trait-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-Trait; Renner, Hock, Bergner-Köther \& Laux, 2018) is used to assess symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in positive and negative affect.
- Positive and Negative Affect Schedule (PANAS; Watson, Clark \& Tellegen, 1988). Positive subscale: Scores ranging from 10 to 50, higher scores represent a better outcome. Negative subscale: Scores ranging from 10 to 50, higher scores represent a worse outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in general self-efficacy
- General self-efficacy is measured using the General-Self-Efficacy Scale (GSE) by Jerusalem \& Schwarzer (1981). The GSE has 10 likert scaled items with values ranging from 1 to 4, higher scores mean a better outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)
- Intention (4 items) and self-efficacy (2 items) are measured using six likert scaled items by Petzold et al. (2017). Values ranging from 1 to 4, higher scores mean a better outcome.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: heart rate variability.
- Heart rate variability is measured with a polar chest strap during 5 minutes of relaxation.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: hand force.
- Hand force is measured with a hand-dynamometer left and right hand.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: leg strength.
- Leg strength is assessed using the 30-second chair-stand-test.
Measured: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start19 Jul 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- miha bodytec GmbH
- Responsible party
- Principal investigator, Antonia Bendau, Charite University, Berlin, Germany
- Investigators
- Andreas Ströhle, Prof.Dr., Study director, Charité-Universitätsmedizin Berlin - Department of Psychiatry and PsychotherapyAntonia Bendau, M.Sc.Psych., Principal investigator, Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499417
- Sponsor's protocol ID
- EA4/058/19 (longterm trial)
- Status last verified
- Aug 2020
- First submitted
- 26 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout
- ClinicalTrials.gov ID
- NCT04499417
- Acronym / sponsor ID
- EA4/058/19 (longterm trial)
- Conditions
- Healthy
- Keywords
- Physical Activity, Exercise, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- miha bodytec GmbH
- Study start
- 19 Jul 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Aug 2020 (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.
The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.
Detailed description
EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. Therefore EMS could lower the barrier to physical activity. The present study focusses on psychological and physical effects of an 8-week EMS workout. Physical activity is notably important for mental and physical health, but is on average far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological and physical effects through a less (subjective) cost-intense strength training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
| Arm | Type | Receives |
|---|---|---|
| Experimental-Condition | Experimental | Device: Electromyostimulation Whole-Body-Workout8 weeks x weekly 20 minutes whole-body-workouts with simultaneous muscle stimulation (EMS). Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity. |
| Sham-Condition | Sham comparator | Device: Electromyostimulation Sham Whole-Body-Workout8 weeks x weekly 20 minutes whole-body-workouts without simultaneous muscle stimulation (EMS). Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are not actually stimulated by EMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject familiarized with experimental procedure and had given written informed consent
- Able to understand German
- Reachability of participant for the eight training sessions
Key exclusion criteria (6 listed)
- Contraindications for physical exercise or EMS-use
- Current EMS-use or intense regular exercise (> 60 min / week)
- Pregnancy
- Current presence of any mental disease
- Acute suicidality
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 |
|---|---|---|
| Electromyostimulation Whole-Body-WorkoutAlso: EMSElectromyostimulation - intensity 5 (muscle stimulation) | Device | Experimental-Condition |
| Electromyostimulation Sham Whole-Body-WorkoutAlso: EMS-ShamElectromyostimulation - intensity 0 (no muscle stimulation) | Device | Sham-Condition |
Primary outcome
Acute change of subjective well-being.
Time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
• Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).
Acute change of subjective relaxation.
Time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
• Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).
Change of acute symptoms of anxiety and depression.
Time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
• The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther \& Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.
9 secondary outcomes
Mid-/longterm changes in depressive symptoms.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in anxiety symptoms.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in affect-related psychological variables.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Mid-/longterm changes in positive and negative affect.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in general self-efficacy
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: heart rate variability.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: hand force.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Change in physical parameters: leg strength.
Time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Andreas Ströhle, Prof.Dr. study director
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Antonia Bendau, M.Sc.Psych. principal investigator
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyostimulation Whole-Body-Workout in people with Healthy, run by Charite University, Berlin, Germany 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonia Bendau, M.Sc.Psych. (+4930450517274, antonia.bendau@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change of subjective well-being. (time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.). 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 5 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.