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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04211493
• Other study ID #: EA4/058/19
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• whole-body-workout
20 minutes whole-body-workout

Device:
• EMS
Electromyostimulation-intensity 5 (muscle stimulation)
• EMS-Placebo
Electromyostimulation-intensity 1 (no muscle stimulation)

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	miha bodytec GmbH, Robert-Enke-Stiftung, Sonnenfeld-Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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