Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout

NCT ID: NCT04499417

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-19

Study Completion Date

2021-12-31

Brief Summary

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The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.

Detailed Description

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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 psychological and physical effects of an 8-week EMS workout. Physical activity is notably important for mental and physical health, but is on average far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological and physical effects through a less (subjective) cost-intense strength training.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.

Study Groups

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Experimental-Condition

8 weeks x weekly 20 minutes whole-body-workouts 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.

Group Type EXPERIMENTAL

Electromyostimulation Whole-Body-Workout

Intervention Type DEVICE

Electromyostimulation - intensity 5 (muscle stimulation)

Sham-Condition

8 weeks x weekly 20 minutes whole-body-workouts 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 the muscles are not actually stimulated by EMS.

Group Type SHAM_COMPARATOR

Electromyostimulation Sham Whole-Body-Workout

Intervention Type DEVICE

Electromyostimulation - intensity 0 (no muscle stimulation)

Interventions

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Electromyostimulation Whole-Body-Workout

Electromyostimulation - intensity 5 (muscle stimulation)

Intervention Type DEVICE

Electromyostimulation Sham Whole-Body-Workout

Electromyostimulation - intensity 0 (no muscle stimulation)

Intervention Type DEVICE

Other Intervention Names

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EMS EMS-Sham

Eligibility Criteria

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Inclusion Criteria

* Subject familiarized with experimental procedure and had given written informed consent
* Able to understand German
* Reachability of participant for the eight training sessions

Exclusion Criteria

* Contraindications for physical exercise or EMS-use
* Current EMS-use or intense regular exercise (\> 60 min / week)
* Pregnancy
* Current presence of any mental disease
* Acute suicidality
* Substance dependencies with actual consumption (except nicotine)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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miha bodytec GmbH

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Antonia Bendau

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Ströhle, Prof.Dr.

Role: STUDY_DIRECTOR

Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Antonia Bendau, M.Sc.Psych.

Role: PRINCIPAL_INVESTIGATOR

Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Locations

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Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Antonia Bendau, M.Sc.Psych.

Role: CONTACT

+4930450517274

Andreas Ströhle, Prof.Dr.

Role: CONTACT

+4930450517217

Facility Contacts

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Role: primary

Other Identifiers

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EA4/058/19 (longterm trial)

Identifier Type: -

Identifier Source: org_study_id

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