Clinical trial NCT04211493: Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout
Official title: Empowering Health: Acute Psychological Effects of a Single Electromyostimulation-Whole-Body-Workout in Participants With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Physical Activity
Physical Exercise
Mental Disorder
Depression
Mental Health
Health Behaviour
Electromyostimulation
EMS
Strength Training
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Sonnenfeld-Stiftung
name: Robert-Enke-Stiftung
name: miha bodytec GmbH
First posted: 2019-12-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: 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:
measure: Change in anxiety symptoms
timeFrame: From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session
measure: Change in general self-efficacy
timeFrame: From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session
measure: Change in intention for physical activity
timeFrame: From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session
measure: Change in self-efficacy regarding physical activity
timeFrame: From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Study officials:
affiliation: Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
name: Andreas Ströhle, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
name: Antonia Bendau, M.Sc.Psych.
role: PRINCIPAL_INVESTIGATOR
References: