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DepressionNCT04211493

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

A study testing whole-body-workout and EMS in people with Depression, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
whole-body-workout and EMS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteGermany
Study dates
22 Nov 2019to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Contraindications for physical exercise
  • Contraindications for EMS-use
  • Current EMS-use
  • Pregnancy
  • Borderline personality disorder
  • Bipolar Disorder
Show all 11Show fewer
  • Schizophrenia
  • Anorexia Nervosa, Bulimia Nervosa
  • Dementia
  • Acute suicidality
  • Substance dependencies with actual consumption (except nicotine)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

    Berlin, 10117

Other trials in Germany

About this study

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

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

Read the 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.

Conditions
Depression
Being tested
whole-body-workout, EMS, EMS-Placebo
Keywords
Physical Activity, Physical Exercise, Mental Disorder, Depression, Mental Health, Health Behaviour, Electromyostimulation, EMS, Strength Training
Medical subject headings
Depression, Motor Activity, Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • whole-body-workoutBehavioural

    20 minutes whole-body-workout

  • EMSDevice

    Electromyostimulation-intensity 5 (muscle stimulation)

  • EMS-PlaceboDevice

    Electromyostimulation-intensity 1 (no muscle stimulation)

Study groups in NCT04211493
Study groupRoleWhat they receive
Experimental-ConditionExperimental20 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.
Receives: Behavioral: whole-body-workout; Device: EMS
Placebo-ConditionPlacebo comparator20 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.
Receives: Behavioral: whole-body-workout; Device: EMS-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start22 Nov 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211493
Sponsor's protocol ID
EA4/058/19
Status last verified
Jul 2021
First submitted
19 Dec 2019
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing whole-body-workout and EMS in people with Depression, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.

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