NCT05981417

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

July 31, 2023

Last Update Submit

May 9, 2024

Conditions

Anxiety DisordersDepressive SymptomsGender-based Violence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Supervised exercise

EXPERIMENTAL

Exercise sessions will beguided by a physiotherapist.

Other: Therapeutic exercise

Home exercise

ACTIVE COMPARATOR

Exercise sessions will be perfomed at home.

Other: Therapeutic exercise

Interventions

Therapeutic exerciseOTHER

Therapeutic exercise sessions will be guided by a physiotherapist.

Supervised exercise

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Vigo

Pontevedra, 36005, Spain

Location

Lorenzo Justo Cousiño

Pontevedra, Spain

Location

Related Publications (12)

  • 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: 18574750BACKGROUND

  • 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: 2602528BACKGROUND

  • 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: 29564546BACKGROUND

  • 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: 33256493BACKGROUND

  • 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: 21495519BACKGROUND

  • 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: 36253441BACKGROUND

  • 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: 33890431BACKGROUND

  • 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: 22116310BACKGROUND

  • 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: 30124130BACKGROUND

  • 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: 30753120BACKGROUND

  • 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: 15626549BACKGROUND

  • 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: 33067493BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, PhD.

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

October 16, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)