Clinical trial NCT04499417: Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout
Official title: Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Physical Activity
Exercise
Mental Health
Health Behaviour
Electromyostimulation
EMS
Strength Training
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: miha bodytec GmbH
First posted: 2020-08-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acute change of subjective well-being.
timeFrame: 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.
measure: Acute change of subjective relaxation.
timeFrame: 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.
measure: Change of acute symptoms of anxiety and depression.
timeFrame: 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:
measure: Mid-/longterm changes in depressive symptoms.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Mid-/longterm changes in anxiety symptoms.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Mid-/longterm changes in affect-related psychological variables.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Mid-/longterm changes in positive and negative affect.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Change in general self-efficacy
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Change in physical parameters: heart rate variability.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Change in physical parameters: hand force.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
measure: Change in physical parameters: leg strength.
timeFrame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
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: