search
Back to results

Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.

Primary Purpose

Anxiety Disorders, Depressive Symptoms, Gender-based Violence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic exercise
Therapeutic exercise
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Supervised exercise

    Home exercise

    Arm Description

    Exercise sessions will beguided by a physiotherapist.

    Exercise sessions will be perfomed at home.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    September 1, 2023
    Sponsor
    University of Vigo
    Collaborators
    Centro de Información Municipal á Muller de Poio, Centro de Información Municipal á Muller de Pontevedra
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05981417
    Brief Title
    Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.
    Official Title
    Effect of a Physiotherapy Intervention Based on Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Vigo
    Collaborators
    Centro de Información Municipal á Muller de Poio, Centro de Información Municipal á Muller de Pontevedra

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Depressive Symptoms, Gender-based Violence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Supervised exercise
    Arm Type
    Experimental
    Arm Description
    Exercise sessions will beguided by a physiotherapist.
    Arm Title
    Home exercise
    Arm Type
    Active Comparator
    Arm Description
    Exercise sessions will be perfomed at home.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic exercise
    Intervention Description
    Therapeutic exercise sessions will be guided by a physiotherapist.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic exercise
    Intervention Description
    Therapeutic exercise sessions will be performed at home.
    Primary Outcome Measure Information:
    Title
    Psychological well-being assessed by Ryff psychological well-being scale.
    Description
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18574750
    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.
    Results Reference
    background
    PubMed Identifier
    2602528
    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.
    Results Reference
    background
    PubMed Identifier
    29564546
    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.
    Results Reference
    background
    PubMed Identifier
    33256493
    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.
    Results Reference
    background
    PubMed Identifier
    21495519
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36253441
    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.
    Results Reference
    background
    PubMed Identifier
    33890431
    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.
    Results Reference
    background
    PubMed Identifier
    22116310
    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.
    Results Reference
    background
    PubMed Identifier
    30124130
    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.
    Results Reference
    background
    PubMed Identifier
    30753120
    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.
    Results Reference
    background
    PubMed Identifier
    15626549
    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.
    Results Reference
    background
    PubMed Identifier
    33067493
    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.
    Results Reference
    background

    Learn more about this trial

    Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.

    We'll reach out to this number within 24 hrs