NCT04875494

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

April 21, 2021

Last Update Submit

May 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Physical Exercise

EXPERIMENTAL
Behavioral: Physical Exercise

Counseling/support group therapy

ACTIVE COMPARATOR
Behavioral: Counseling/support group therapy

Control

NO INTERVENTION

no intervention

Interventions

6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims

Counseling/support group therapy

6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor

Physical Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having experienced domestic violence at some time in the past 2 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIDFF-51

Châlons-en-Champagne, 51000, France

Location

MeSH Terms

Interventions

CounselingExercise

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephanie CAILLIES, PhD

    Université de Reims Champagne-Ardenne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

May 6, 2021

Study Start

February 24, 2020

Primary Completion

February 27, 2021

Study Completion

April 5, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations