protocolSection identificationModule nctId: NCT06264895, orgStudyIdInfo id: Trinity College Dublin 211202, briefTitle: Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction., acronym: LEAP-W, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, descriptionModule briefSummary: Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population., conditionsModule conditions: Social Exclusion, conditions: Chronic Disease, conditions: Physical Disability, conditions: Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single -arm longitudinal cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Hand grip dynamometry, secondaryOutcomes measure: Limb circumference, secondaryOutcomes measure: 10 Metre Walk Test, secondaryOutcomes measure: 2 Minute Walk Test, secondaryOutcomes measure: The Chair Stand Test, secondaryOutcomes measure: Single Leg Stance Test, secondaryOutcomes measure: Numerical Rating Scale (NRS), secondaryOutcomes measure: Clinical Frailty Scale (CFS), secondaryOutcomes measure: SHARE-Frailty Instrument (FI), secondaryOutcomes measure: Mini Nutritional Assessment (MNA), secondaryOutcomes measure: Short Form-12 V2, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False