xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981417</url>
    </required_header>
    <id_info>
      <org_study_id>UVigo</org_study_id>
      <nct_id>NCT05981417</nct_id>
    </id_info>
    <brief_title>Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.</brief_title>
    <official_title>Effect of a Physiotherapy Intervention Based on Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Vigo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centro de Información Municipal á Muller de Poio</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centro de Información Municipal á Muller de Pontevedra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Vigo</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The scientific literature shows that women subjected to gender violence suffer a&#xD;
        deterioration in mental health (anxiety, stress and depression). In particular, a recent&#xD;
        study carried out in Galicia found a high incidence of post-traumatic stress, depression and&#xD;
        low self-esteem in women victims of gender violence.&#xD;
  &#xD;
        The efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated,&#xD;
        as has the link between gender violence and deterioration of mental health, with a high&#xD;
        incidence of post-traumatic stress. However, research on the effect of therapeutic exercise&#xD;
        in battered women is very limited.&#xD;
  &#xD;
        For this reason, the aim of the present project is to evaluate the effect of a therapeutic&#xD;
        exercise program on mental health in women who have suffered gender violence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Psychological well-being assessed by Ryff psychological well-being scale.</measure>
      <time_frame>8 weeks</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Anxiety Disorders</condition>
    <condition>Depressive Symptoms</condition>
    <condition>Gender-based Violence</condition>
    <arm_group>
      <arm_group_label>Supervised exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise sessions will beguided by a physiotherapist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Exercise sessions will be perfomed at home.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therapeutic exercise</intervention_name>
      <description>Therapeutic exercise sessions will be guided by a physiotherapist.</description>
      <arm_group_label>Supervised exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therapeutic exercise</intervention_name>
      <description>Therapeutic exercise sessions will be performed at home.</description>
      <arm_group_label>Home exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women of legal age with a history of gender-based violence who come to the women's&#xD;
               center or are included in the women's center's programs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Consumption of alcohol or other drugs.&#xD;
  &#xD;
            -  Musculoskeletal disorders, recent surgery, as well as any physical problem that&#xD;
               prevents exercise.&#xD;
  &#xD;
            -  Any medical contraindication to exercise.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Having any affirmative answer in the PARQ questionnaire (Physical Activity Readiness&#xD;
               Questionnaire).&#xD;
  &#xD;
            -  Participants who do not have the capacity to consent to participate will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <reference>
      <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.</citation>
      <PMID>18574750</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>2602528</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>29564546</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33256493</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21495519</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36253441</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33890431</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22116310</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30124130</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30753120</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>15626549</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33067493</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Vigo</investigator_affiliation>
      <investigator_full_name>Lorenzo Antonio Justo Cousino, PhD</investigator_full_name>
      <investigator_title>Physical Therapist, PhD.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981417
  org study id: UVigo
  nct id: NCT05981417
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Psychological well-being assessed by Ryff psychological well-being scale.
  time frame: 8 weeks
  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.
  arm group label: Supervised exercise
  arm group type: Experimental
  description: Exercise sessions will beguided by a physiotherapist.
  arm group label: Home exercise
  arm group type: Active Comparator
  description: Exercise sessions will be perfomed at home.
  intervention type: Other
  intervention name: Therapeutic exercise
  description: Therapeutic exercise sessions will be guided by a physiotherapist.
  arm group label: Supervised exercise
  intervention type: Other
  intervention name: Therapeutic exercise
  description: Therapeutic exercise sessions will be performed at home.
  arm group label: Home exercise
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  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.
  PMID: 18574750
  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.
  PMID: 2602528
  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.
  PMID: 29564546
  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.
  PMID: 33256493
  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.
  PMID: 21495519
  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.
  PMID: 36253441
  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.
  PMID: 33890431
  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.
  PMID: 22116310
  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.
  PMID: 30124130
  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.
  PMID: 30753120
  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.
  PMID: 15626549
  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.
  PMID: 33067493
  responsible party type: Principal Investigator
  investigator affiliation: University of Vigo
  investigator full name: Lorenzo Antonio Justo Cousino, PhD
  investigator title: Physical Therapist, PhD.
  mesh term: Anxiety Disorders
  mesh term: Depression
  sharing ipd: No