Evaluation of a Low-threshold Exercise And Protein Supplementation Intervention for Women (LEAP-W) Experiencing Homelessness and Addiction: Protocol for a Single Site Intervention Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
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.
Detailed Description
Previous linked research of exercise interventions in people experiencing homelessness, demonstrated high retention with excellent engagement and feedback from its female participants, yet caution was observed around engaging in a mixed exercised programme with men. Women have traditionally been underserved in research and policy, yet multiple sources cite women as the fastest growing homeless demographic. No study has examined how targeted women-only exercise programmes with nutritional supplementation work in practice in this population.
The overall aim of this study is to explore physical functioning and frailty outcomes of an exercise intervention with protein supplementation in a group of (non-geriatric) women experiencing homelessness and addiction challenges.
The objectives are:
- To evaluate recruitment, retention and adherence rates, and any adverse effects of the intervention.
- To evaluate pre- and post-intervention levels of physical, nutritional and frailty status, pain and general health status.
- To evaluate programme feedback and gain deeper insights into participants perspectives and experiences of the exercise intervention.
This mixed-methods study will involve a single-arm intervention which will take place in Dublin city centre, in a day-service centre which provides services for women who are homeless and/or in addiction. Following the intervention qualitative research in the form of individual exit interviews will be conducted with 20 participants or up to the point of data saturation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult women (18-65 years) accessing services in Jane's Place who consent to participation.
Exclusion Criteria
- •Any person not meeting the age eligibility criteria.
- •Any person identifying as a male.
- •Any person lacking capacity to give consent.
- •Any person with major physical/medical or cognitive challenges which would preclude ability to safely complete the assessment or
- •Any person with insufficient English language ability to give fully informed consent.
Outcomes
Primary Outcomes
Adverse events
Time Frame: 12 weeks
An unfavourable and unintended sign, symptom or disease having been absent at baseline, or, if present at baseline, appears to worsen and is temporally associated with medical treatment or procedure, regardless of the attribution.
Recruitment
Time Frame: 12 weeks
Number recruited to the study
Retention
Time Frame: 12 weeks
Number of repeat visits
Secondary Outcomes
- Single Leg Stance Test(up to 10 weeks)
- SHARE-Frailty Instrument (FI)(up to 10 weeks)
- 2 Minute Walk Test(up to 10 weeks)
- The Chair Stand Test(up to 10 weeks)
- Numerical Rating Scale (NRS)(up to 10 weeks)
- Mini Nutritional Assessment (MNA)(up to 10 weeks)
- Hand grip dynamometry(up to 10 weeks)
- Limb circumference(up to 10 weeks)
- Clinical Frailty Scale (CFS)(up to 10 weeks)
- 10 Metre Walk Test(up to 10 weeks)
- Short Form-12 V2(up to 10 weeks)
Investigators
Julie Broderick
Dr. Julie Broderick, Assistant Professor, Head of Discipline of Physiotherapy
University of Dublin, Trinity College