Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT04211493
Status:
UNKNOWN
Last Update Posted:
2021-08-02
First Post:
2019-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not aware of the study hypothesis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-21', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depressive symptoms', 'timeFrame': 'From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety symptoms', 'timeFrame': 'From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session', '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.'}, {'measure': 'Change in general self-efficacy', 'timeFrame': 'From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session', '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.'}, {'measure': 'Change in intention for physical activity', 'timeFrame': 'From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session', '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.'}, {'measure': 'Change in self-efficacy regarding physical activity', 'timeFrame': 'From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Physical Exercise', 'Mental Disorder', 'Depression', 'Mental Health', 'Health Behaviour', 'Electromyostimulation', 'EMS', 'Strength Training'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The study investigates the acute psychological effects of a whole-body-workout using Electromyostimulation (EMS) in participants with depression and healthy individuals.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject familiarized with experimental procedure and had given written informed consent\n* Depression, according to ICD-10\n* BDI-II Score ≥ 14\n* Able to understand German\n* Reachability of participant for the two training sessions\n\nExclusion Criteria:\n\n* Contraindications for physical exercise\n* Contraindications for EMS-use\n* Current EMS-use\n* Pregnancy\n* Borderline personality disorder\n* Bipolar Disorder\n* Schizophrenia\n* Anorexia Nervosa, Bulimia Nervosa\n* Dementia\n* Acute suicidality\n* Substance dependencies with actual consumption (except nicotine)'}, 'identificationModule': {'nctId': 'NCT04211493', 'briefTitle': 'Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Empowering Health: Acute Psychological Effects of a Single Electromyostimulation-Whole-Body-Workout in Participants With Depression', 'orgStudyIdInfo': {'id': 'EA4/058/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental-Condition', 'description': '20 minutes whole-body-workout with simultaneous muscle stimulation (EMS).\n\nParticipants 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.', 'interventionNames': ['Behavioral: whole-body-workout', 'Device: EMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-Condition', 'description': '20 minutes whole-body-workout without simultaneous muscle stimulation (EMS).\n\nParticipants 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.', 'interventionNames': ['Behavioral: whole-body-workout', 'Device: EMS-Placebo']}], 'interventions': [{'name': 'whole-body-workout', 'type': 'BEHAVIORAL', 'description': '20 minutes whole-body-workout', 'armGroupLabels': ['Experimental-Condition', 'Placebo-Condition']}, {'name': 'EMS', 'type': 'DEVICE', 'description': 'Electromyostimulation-intensity 5 (muscle stimulation)', 'armGroupLabels': ['Experimental-Condition']}, {'name': 'EMS-Placebo', 'type': 'DEVICE', 'description': 'Electromyostimulation-intensity 1 (no muscle stimulation)', 'armGroupLabels': ['Placebo-Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'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', 'affiliation': 'Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sonnenfeld-Stiftung', 'class': 'UNKNOWN'}, {'name': 'Robert-Enke-Stiftung', 'class': 'UNKNOWN'}, {'name': 'miha bodytec GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonia Bendau', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}