Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout

August 3, 2020 updated by: Antonia Bendau, Charite University, Berlin, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject familiarized with experimental procedure and had given written informed consent
  • Able to understand German
  • Reachability of participant for the eight training sessions

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental-Condition

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.
Device: Electromyostimulation Whole-Body-Workout
Electromyostimulation - intensity 5 (muscle stimulation)
Other Names:
  • EMS
Sham Comparator: Sham-Condition

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.
Device: Electromyostimulation Sham Whole-Body-Workout
Electromyostimulation - intensity 0 (no muscle stimulation)
Other Names:
  • EMS-Sham

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mid-/longterm changes in depressive symptoms.
Time Frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
• Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002). Sum scores ranging from 0 to 27, higher values indicate a worse outcome.
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).
• Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006). Sum scores ranging from 0 to 21, higher values indicate a worse outcome.
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).
• 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.
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).
• 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.
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).
• 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.
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).
• 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.
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).
• Heart rate variability is measured with a polar chest strap during 5 minutes of relaxation.
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).
• Hand force is measured with a hand-dynamometer left and right hand.
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).
• Leg strength is assessed using the 30-second chair-stand-test.
Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
miha bodytec GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andreas Ströhle, Prof.Dr., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
  • Principal Investigator: Antonia Bendau, M.Sc.Psych., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA4/058/19 (longterm trial)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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