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Clinical Trials/NCT04211493
NCT04211493UnknownNot Applicable

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

Charite University, Berlin, Germany1 site in 1 country34 target enrollmentStarted: November 22, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
34
Locations
1
Primary Endpoint
Change in depressive symptoms

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participants are not aware of the study hypothesis.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •Acute suicidality
  • •Substance dependencies with actual consumption (except nicotine)

Arms & Interventions

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.

Intervention: whole-body-workout (Behavioral)

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.

Intervention: EMS (Device)

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.

Intervention: whole-body-workout (Behavioral)

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.

Intervention: EMS-Placebo (Device)

Outcomes

Primary Outcomes

Change in depressive symptoms

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

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antonia Bendau

Principal Investigator

Charite University, Berlin, Germany

Study Sites (1)

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