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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04499417
Enrollment
72
Registered
2020-08-05
Start date
2020-07-19
Completion date
2021-12-31
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Physical Activity, Exercise, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training

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.

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.

Interventions

DEVICEElectromyostimulation Whole-Body-Workout

Electromyostimulation - intensity 5 (muscle stimulation)

DEVICEElectromyostimulation Sham Whole-Body-Workout

Electromyostimulation - intensity 0 (no muscle stimulation)

Sponsors

miha bodytec GmbH
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.

Intervention model description

The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
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).
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).
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

MeasureTime frameDescription
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.
Change in general self-efficacyBaseline (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.
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.
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.
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.
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.
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.
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.
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.

Countries

Germany

Contacts

Primary ContactAntonia Bendau, M.Sc.Psych.
antonia.bendau@charite.de+4930450517274
Backup ContactAndreas Ströhle, Prof.Dr.
andreas.stroehle@charite.de+4930450517217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026