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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499417
• Other study ID #: EA4/058/19 (longterm trial)
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Charite University, Berlin, Germany
• Contact: Antonia Bendau, M.Sc.Psych.
• Phone: +4930450517274
• Email: antonia.bendau[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• 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

• 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)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Electromyostimulation Whole-Body-Workout
Electromyostimulation - intensity 5 (muscle stimulation)
• Electromyostimulation Sham Whole-Body-Workout
Electromyostimulation - intensity 0 (no muscle stimulation)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	miha bodytec GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
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.	Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).