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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

72

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Charite University, Berlin, Germany

Collaborators

miha bodytec GmbH

Investigators

  • 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)

July 19, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 26, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID 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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