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

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

The study investigates the acute psychological effects of a whole-body-workout using Electromyostimulation (EMS) in participants with depression and healthy individuals.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: whole-body-workout; Device: EMS; Device: EMS-Placebo

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Participation Criteria

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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental-Condition; 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; 20 minutes whole-body-workout; Device: EMS; Electromyostimulation-intensity 5 (muscle stimulation)
Placebo Comparator: Placebo-Condition; 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; 20 minutes whole-body-workout; Device: EMS-Placebo; Electromyostimulation-intensity 1 (no muscle stimulation)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: miha bodytec GmbH; Sonnenfeld-Stiftung; Robert-Enke-Stiftung
• 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

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 21, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Physical Activity; Mental Health; Physical Exercise; Strength Training; Mental Disorder; Health Behaviour; Electromyostimulation; EMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: EA4/058/19

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