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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04875494
Other study ID # DDCSPP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2020
Est. completion date April 5, 2021

Study information

Verified date May 2021
Source Université de Reims Champagne-Ardenne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 5, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Counseling/support group therapy
6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims
Physical Exercise
6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor

Locations

Country Name City State
France CIDFF-51 Châlons-en-Champagne

Sponsors (1)

Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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
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