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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT04499417
Collaborator
miha bodytec GmbH (Other)
72
1
2
16.4
4.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Electromyostimulation Whole-Body-Workout
  • Device: Electromyostimulation Sham Whole-Body-Workout
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.
Primary Purpose:
Treatment
Official Title:
Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout
Actual Study Start Date :
Jul 19, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Acute change of subjective well-being. [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).

    2. Acute change of subjective relaxation. [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).

    3. Change of acute symptoms of anxiety and depression. [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.

    Secondary Outcome Measures

    1. Mid-/longterm changes in depressive symptoms. [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.

    2. Mid-/longterm changes in anxiety symptoms. [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.

    3. Mid-/longterm changes in affect-related psychological variables. [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.

    4. Mid-/longterm changes in positive and negative affect. [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.

    5. Change in general self-efficacy [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.

    6. Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity) [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.

    7. Change in physical parameters: heart rate variability. [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.

    8. Change in physical parameters: hand force. [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.

    9. Change in physical parameters: leg strength. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonia Bendau, Principal Investigator, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT04499417
    Other Study ID Numbers:
    • EA4/058/19 (longterm trial)
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Aug 5, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Antonia Bendau, Principal Investigator, Charite University, Berlin, Germany

    Study Results

    No Results Posted as of Aug 5, 2020