Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout

Study Overview
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Brief Summary
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The study investigates the acute psychological effects of a whole-body-workout using Electromyostimulation (EMS) in participants with depression and 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 acute psychological effects of an EMS workout - especially with regard to the reduction of depressive symptoms. Physical activity is notably important for patients with depression and shows multiple positive psychological and physical effects. But due to disease-related factors like lethargy, physical activity is far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological effects through a less (subjective) cost-intense strength training.

Official Title
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Empowering Health: Acute Psychological Effects of a Single Electromyostimulation-Whole-Body-Workout in Participants With Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: whole-body-workout
* Device: EMS
* Device: EMS-Placebo


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 Depression, according to ICD-10 BDI-II Score ≥ 14 Able to understand German Reachability of participant for the two training sessions Exclusion Criteria: Contraindications for physical exercise Contraindications for EMS-use Current EMS-use Pregnancy Borderline personality disorder Bipolar Disorder Schizophrenia Anorexia Nervosa, Bulimia Nervosa Dementia 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: Crossover Assignment
Interventional Model Description: The study has a randomised placebo-controlled crossover design. Every participant exercises two training-sessions (experimental-condition, placebo-condition) in randomized order with one week fade-out phase inbetween.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental-Condition<br>20 minutes whole-body-workout 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. | Behavioral: whole-body-workout<br>* 20 minutes whole-body-workout<br>Device: EMS<br>* Electromyostimulation-intensity 5 (muscle stimulation)<br>|
| Placebo Comparator: Placebo-Condition<br>20 minutes whole-body-workout 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 they are stimulated with the lowest possible stimulation intensity (1). This is perceptible as a slight tingling sensation but the impulse intensity lies below the muscular threshold and therefore generates no muscular activity. | Behavioral: whole-body-workout<br>* 20 minutes whole-body-workout<br>Device: EMS-Placebo<br>* Electromyostimulation-intensity 1 (no muscle stimulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | Depressive symptoms are measured using the State-Scale of the State-Trait Depression Scales (STDS) by Spaderna, Schmukle & Krohne (2002). The SDTS State-Scale has two subscales with each 5 likert scaled items with values ranging from 1 to 4. Higher scores mean a worse outcome for the first subscale and a better outcome for the second subscale. | From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms | Anxiety symptoms are measured using the the State-Scale of the State-Trait Anxiety Inventory (STAI) by Laux, Glanzmann, Schaffner & Spielberger (1981). The STAI State-Scale has 20 likert scaled items with values ranging from 1 to 4, higher scores mean a worse outcome. | From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session | 
| 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. | From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session | 
| Change in intention for physical activity | Intention for physical activity is measured using two likert scaled items by Petzold et al. (2017). Values ranging from 1 to 4, higher scores mean a better outcome. | From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session | 
| Change in self-efficacy regarding physical activity | Self-efficacy is measured using two likert scaled items by Petzold et al. (2017). Values ranging from 1 to 4, higher scores mean a better outcome. | From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session | 

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