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

NCT04499417 | Unknown

• 1 other identifier: EA4/058/19 (longterm trial)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Physical Activity; Exercise; Mental Health; Health Behaviour; Electromyostimulation; EMS; Strength Training

Outcome Measures

Primary Outcomes (3)

• Acute change of subjective well-being.

  • Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).

  From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

• Acute change of subjective relaxation.

  • Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).

  From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

• Change of acute symptoms of anxiety and depression.

  • The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther \& Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.

  From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

Secondary Outcomes (9)

• Mid-/longterm changes in depressive symptoms.

  Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

• Mid-/longterm changes in anxiety symptoms.

  Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

• Mid-/longterm changes in affect-related psychological variables.

  Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

• Mid-/longterm changes in positive and negative affect.

  Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

• Change in general self-efficacy

  Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).

Study Arms (2)

Experimental-Condition

EXPERIMENTAL

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.

Device: Electromyostimulation Whole-Body-Workout

Sham-Condition

SHAM COMPARATOR

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.

Device: Electromyostimulation Sham Whole-Body-Workout

Interventions

Electromyostimulation Whole-Body-Workout DEVICE

Electromyostimulation - intensity 5 (muscle stimulation)

Also known as: EMS

Experimental-Condition

Electromyostimulation Sham Whole-Body-Workout DEVICE

Electromyostimulation - intensity 0 (no muscle stimulation)

Also known as: EMS-Sham

Sham-Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• miha bodytec GmbH: collaborator

Study Sites (1)

Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Andreas Ströhle, Prof.Dr.

  Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

  STUDY DIRECTOR

• Antonia Bendau, M.Sc.Psych.

  Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Bendau, M.Sc.Psych.

CONTACT

+4930450517274; antonia.bendau@charite.de

Andreas Ströhle, Prof.Dr.

CONTACT

+4930450517217; andreas.stroehle@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 5, 2020
• Study Start: July 19, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)