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临床试验/NCT04875494
NCT04875494已完成不适用

Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims

Université de Reims Champagne-Ardenne1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
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)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Physical Exercise

Experimental

干预措施: Physical Exercise (Behavioral)

Counseling/support group therapy

Active Comparator

干预措施: Counseling/support group therapy (Behavioral)

Control

No Intervention

no intervention

结局指标

主要结局

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)

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Université de Reims Champagne-Ardenne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabien Legrand

Clinical Professor

Université de Reims Champagne-Ardenne

研究点 (1)

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