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

NCT04211493 | Unknown

• 1 other identifier: EA4/058/19
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

Physical Activity; Physical Exercise; Mental Disorder; Depression; Mental Health; Health Behaviour; Electromyostimulation; EMS; Strength Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in anxiety symptoms

  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

  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

  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

  From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session

Study Arms (2)

Experimental-Condition

EXPERIMENTAL

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; Device: EMS

Placebo-Condition

PLACEBO COMPARATOR

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; Device: EMS-Placebo

Interventions

whole-body-workout BEHAVIORAL

20 minutes whole-body-workout

Experimental-Condition; Placebo-Condition

EMS DEVICE

Electromyostimulation-intensity 5 (muscle stimulation)

Experimental-Condition

EMS-Placebo DEVICE

Electromyostimulation-intensity 1 (no muscle stimulation)

Placebo-Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Sonnenfeld-Stiftung: collaborator
• Robert-Enke-Stiftung: collaborator
• miha bodytec GmbH: collaborator

Study Sites (1)

Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Depression; Motor Activity; Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Andreas Ströhle, Prof.Dr.

  Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

  STUDY DIRECTOR

• Antonia Bendau, M.Sc.Psych.

  Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of the study hypothesis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: November 22, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)