- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875494
Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims
May 5, 2021 updated by: Fabien Legrand, Université de Reims Champagne-Ardenne
Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Châlons-en-Champagne, France, 51000
- CIDFF-51
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- having experienced domestic violence at some time in the past 2 months
Exclusion Criteria:
- not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year)
- absence of medical contraindication to exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
no intervention
|
|
Experimental: Physical Exercise
|
6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor
|
Active Comparator: Counseling/support group therapy
|
6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline
|
magnitude of change in global and physical self-esteem from pre- to post-study.
Minimum = -150; Maximum = +150
|
baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Stephanie CAILLIES, PhD, Université de Reims Champagne-Ardenne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2020
Primary Completion (Actual)
February 27, 2021
Study Completion (Actual)
April 5, 2021
Study Registration Dates
First Submitted
April 21, 2021
First Submitted That Met QC Criteria
May 5, 2021
First Posted (Actual)
May 6, 2021
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 5, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DDCSPP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Domestic Violence
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingDomestic ViolencePeru
-
Medical University of South CarolinaAgency for Healthcare Research and Quality (AHRQ)Completed
-
Fatemeh KhakshoorCompletedDomestic ViolenceIran, Islamic Republic of
Clinical Trials on Physical Exercise
-
Universidade Estadual da ParaibaUniversity of Campinas, BrazilUnknown
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Clarice Maria de Lucena MartinsCompletedMetabolic Diseases | Physical Activity
-
Instituto de Cardiologia do Rio Grande do SulFundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilTerminatedObesity | Sedentary Lifestyle | Hypercholesterolemia | High Blood PressureBrazil
-
McGill UniversityUniversité du Québec à Trois-Rivières; Université de Montréal; Concordia University... and other collaboratorsRecruiting
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Universidad Católica San Antonio de MurciaCompleted
-
Cardiff UniversityCompletedParkinson's DiseaseUnited Kingdom
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
Göteborg UniversityVastra Gotaland Region; Sahlgrenska University Hospital, SwedenCompletedChronic Widespread PainSweden