Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT04875494
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global)', 'timeFrame': 'baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline', 'description': 'magnitude of change in global and physical self-esteem from pre- to post-study. Minimum = -150; Maximum = +150'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Domestic Violence']}, 'descriptionModule': {'briefSummary': 'The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection', 'detailedDescription': 'The present study design includes three arms (two intervention arms): Physical Exercise (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone interview by one of the authors. A permutated block design with a block size of three was used. For each participant in Groups A and B, the assigned intervention was started the week following the initial interview, and lasted 6 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having experienced domestic violence at some time in the past 2 months\n\nExclusion Criteria:\n\n* not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year)\n* absence of medical contraindication to exercise'}, 'identificationModule': {'nctId': 'NCT04875494', 'briefTitle': 'Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims', 'orgStudyIdInfo': {'id': 'DDCSPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Exercise', 'interventionNames': ['Behavioral: Physical Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Counseling/support group therapy', 'interventionNames': ['Behavioral: Counseling/support group therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no intervention'}], 'interventions': [{'name': 'Counseling/support group therapy', 'type': 'BEHAVIORAL', 'description': '6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims', 'armGroupLabels': ['Counseling/support group therapy']}, {'name': 'Physical Exercise', 'type': 'BEHAVIORAL', 'description': '6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor', 'armGroupLabels': ['Physical Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51000', 'city': 'Châlons-en-Champagne', 'country': 'France', 'facility': 'CIDFF-51', 'geoPoint': {'lat': 48.95393, 'lon': 4.36724}}], 'overallOfficials': [{'name': 'Stephanie CAILLIES, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Reims Champagne-Ardenne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Fabien Legrand', 'investigatorAffiliation': 'Université de Reims Champagne-Ardenne'}}}}