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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Electromyostimulation Whole-Body-Workout
* Device: Electromyostimulation Sham Whole-Body-Workout


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental-Condition<br>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<br>* Electromyostimulation - intensity 5 (muscle stimulation)<br>* Other names: EMS;|
| Sham Comparator: Sham-Condition<br>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<br>* Electromyostimulation - intensity 0 (no muscle stimulation)<br>* Other names: EMS-Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute change of subjective well-being. | • 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. | • 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. | • 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. | • 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. | • 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. | • 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. | • 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 | • 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) | • 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. | • 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. | • 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. | • 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Exercise, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training