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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05981417
Other study ID # UVigo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date December 30, 2023

Study information

Verified date May 2024
Source University of Vigo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). In particular, a recent study carried out in Galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence. The efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated, as has the link between gender violence and deterioration of mental health, with a high incidence of post-traumatic stress. However, research on the effect of therapeutic exercise in battered women is very limited. For this reason, the aim of the present project is to evaluate the effect of a therapeutic exercise program on mental health in women who have suffered gender violence.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women of legal age with a history of gender-based violence who come to the women's center or are included in the women's center's programs. Exclusion Criteria: - Consumption of alcohol or other drugs. - Musculoskeletal disorders, recent surgery, as well as any physical problem that prevents exercise. - Any medical contraindication to exercise. - Pregnancy. - Having any affirmative answer in the PARQ questionnaire (Physical Activity Readiness Questionnaire). - Participants who do not have the capacity to consent to participate will be excluded.

Study Design


Intervention

Other:
Therapeutic exercise
Therapeutic exercise sessions will be guided by a physiotherapist.
Therapeutic exercise
Therapeutic exercise sessions will be performed at home.

Locations

Country Name City State
Spain Lorenzo Justo Cousiño Pontevedra
Spain University of Vigo Pontevedra

Sponsors (3)

Lead Sponsor Collaborator
University of Vigo Centro de Información Municipal á Muller de Poio, Centro de Información Municipal á Muller de Pontevedra

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Carek PJ, Laibstain SE, Carek SM. Exercise for the treatment of depression and anxiety. Int J Psychiatry Med. 2011;41(1):15-28. doi: 10.2190/PM.41.1.c. — View Citation

Dragesund T, Raheim M. Norwegian psychomotor physiotherapy and patients with chronic pain: patients' perspective on body awareness. Physiother Theory Pract. 2008 Jul-Aug;24(4):243-54. doi: 10.1080/09593980701738400. — View Citation

Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8. doi: 10.1016/j.amepre.2004.09.003. — View Citation

Friis S, Skatteboe UB, Hope MK, Vaglum P. Body awareness group therapy for patients with personality disorders. 2. Evaluation of the Body Awareness Rating Scale. Psychother Psychosom. 1989;51(1):18-24. doi: 10.1159/000288129. — View Citation

Gordon BR, McDowell CP, Lyons M, Herring MP. Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Sci Rep. 2020 Oct 16;10(1):17548. doi: 10.1038/s41598-020-74608-6. — View Citation

Herring MP, Jacob ML, Suveg C, Dishman RK, O'Connor PJ. Feasibility of exercise training for the short-term treatment of generalized anxiety disorder: a randomized controlled trial. Psychother Psychosom. 2012;81(1):21-8. doi: 10.1159/000327898. Epub 2011 Nov 22. — View Citation

Jonker IE, Lako DAM, Beijersbergen MD, Sijbrandij M, van Hemert AM, Wolf JRLM. Factors Related To Depression and Post-Traumatic Stress Disorder in Shelter-Based Abused Women. Violence Against Women. 2019 Mar;25(4):401-420. doi: 10.1177/1077801218790700. Epub 2018 Aug 20. — View Citation

Mondolfi Miguel ML, Rosa Pino-Juste M. Psycho-social profile of battered women in Galicia, Spain: Distress as a result of intimate partner violence and child abuse. Health Care Women Int. 2019 Nov;40(11):1229-1248. doi: 10.1080/07399332.2019.1571061. Epub 2019 Feb 12. — View Citation

Ross RE, VanDerwerker CJ, Saladin ME, Gregory CM. The role of exercise in the treatment of depression: biological underpinnings and clinical outcomes. Mol Psychiatry. 2023 Jan;28(1):298-328. doi: 10.1038/s41380-022-01819-w. Epub 2022 Oct 17. — View Citation

Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21. — View Citation

Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30. — View Citation

Strohle A. Sports psychiatry: mental health and mental disorders in athletes and exercise treatment of mental disorders. Eur Arch Psychiatry Clin Neurosci. 2019 Aug;269(5):485-498. doi: 10.1007/s00406-018-0891-5. Epub 2018 Mar 21. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological well-being assessed by Ryff psychological well-being scale. This self-report instrument consist of a series of statements reflecting the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement. 8 weeks
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