Back to resultsEmpowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
whole-body-workout
EMS
EMS-Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Physical Activity, Physical Exercise, Mental Disorder, Depression, Mental Health, Health Behaviour, Electromyostimulation, EMS, 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)
Sites / Locations
- Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental-Condition
Placebo-Condition
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04211493
First Posted
December 19, 2019
Last Updated
July 27, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Sonnenfeld-Stiftung, Robert-Enke-Stiftung, miha bodytec GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04211493
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Sonnenfeld-Stiftung, Robert-Enke-Stiftung, miha bodytec GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Physical Activity, Physical Exercise, Mental Disorder, Depression, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Participants are not aware of the study hypothesis.
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental-Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo-Condition
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
whole-body-workout
Intervention Description
20 minutes whole-body-workout
Intervention Type
Device
Intervention Name(s)
EMS
Intervention Description
Electromyostimulation-intensity 5 (muscle stimulation)
Intervention Type
Device
Intervention Name(s)
EMS-Placebo
Intervention Description
Electromyostimulation-intensity 1 (no muscle stimulation)
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in anxiety symptoms
Description
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.
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
Title
Change in general self-efficacy
Description
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.
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
Title
Change in intention for physical activity
Description
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.
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
Title
Change in self-efficacy regarding physical activity
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.Dr.
Organizational Affiliation
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonia Bendau, M.Sc.Psych.
Organizational Affiliation
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout
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