https://orcid.org/0000-0002-3425-4717
Figures
Abstract
Background
Frailty is a complex multi-dimensional state of increased vulnerability to adverse outcomes and is 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 evaluate the feasibility and impact of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.
Methods
This quantitatively driven, sequential single-arm mixed-methods feasibility study will evaluate the feasibility and impact of a low threshold trauma informed exercise intervention on physical functioning and frailty in women experiencing homelessness and addiction. Physical function (10m Walk Test, 2Min Walk Test, Single Leg Stance, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-Frailty Instrument) and nutritional status (Mini-Nutritional Status), pain (Numerical Rating Scale) and quality of life (SF 12-V2) will be evaluated. The 10-week intervention will involve a 3-times weekly exercise programme with protein supplementation. 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 known 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 vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow the research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population. (300).
Citation: Kennedy F, Murray D, Ní Cheallaigh C, Romero-Ortuno R, Broderick J (2025) Evaluation of a Low-threshold Exercise And Protein supplementation intervention for Women (LEAP-W) experiencing homelessness and addiction: Protocol for a single-arm mixed methods feasibility study. PLoS ONE 20(2): e0300412. https://doi.org/10.1371/journal.pone.0300412
Editor: Emiliano Cè, Università degli Studi di Milano: Universita degli Studi di Milano, ITALY
Received: May 2, 2024; Accepted: December 18, 2024; Published: February 6, 2025
Copyright: © 2025 Kennedy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: No datasets were generated or analyzed during the current study. All relevant data from this study will be made available upon study completion.
Funding: This study was funded by the 1252 Postgraduate Research Studentship, from The University of Dublin, Trinity College Dublin and a New Foundations Grant from the Irish Research Council. The funders played no role in the design, conduct, or reporting of this study.
Competing interests: The authors have declared that no competing interests exist.
Introduction
The world’s population is ageing rapidly [1]. Frailty, a sometimes-preventable consequence of a rapidly ageing population, is a complex state of cumulative decline across multiple physiological systems which renders a person vulnerable to adverse health outcomes and greatly challenges healthcare systems [2]. Targeted interventions to manage frailty in older adults are recommended and exercise with nutritional supplementation has proven effectiveness in combatting and mitigating frailty [3–5].
Frailty as a construct is a geriatric concept which is strongly associated with increasing age [6]. Notwithstanding that biological age is closely linked to frailty, it is known that chronological age alone will not identify frailty as the health and functional life status of populations are so variable [7]. Growing evidence indicates the prevalence of premature ageing and frailty in non-geriatric populations [8, 9]. ‘Younger frailty’ has been identified in populations of lower socioeconomic status, who live in areas of greater deprivation and experience an earlier onset of illness and disability [10, 11]. In a study investigating people experiencing homelessness (PEH) admitted for inpatient care, 83% of participants had mobility problems and 70% were frail or pre-frail despite a low median age of 45 years [12, 13]. In an analysis of UK Biobank participants aged 37–73 years, 42% of individuals living with frailty were within the most socially deprived quintile of the cohort [10]. Females are known to experience higher levels of frailty compared to males [14, 15]. It is therefore not surprising that poor physical functioning and frailty is experienced by young women who are homeless and use drugs [16, 17].
Health services for PEH frequently focus on crisis-based medical, nursing and addiction services, often with a gender-blind lens [18, 19]. High levels of stigma, shame and fear result in women accessing services even less and seeking help at breaking point with complex coinciding physical and mental health needs [20, 21]. Homelessness and substance use in women is inter-sectoral and may overlap with trauma, abuse, domestic and sexual violence and exploitation, and the needs of these women are complex and unique [22]. Pathways into homelessness are frequently different to that of men and require a different approach [23]. Internationally, gender-based services for women who are experiencing homelessness and addiction are lacking and services are mostly delivered in mixed gender settings [18, 19]. Women-specific services are recommended to increase safety, stability, wellbeing, and psychosocial functioning to respond meaningfully to the serious health and social care needs of women in this setting [24]. Gender specific and gender sensitive research is required to fill this knowledge gap [25].
Our prior research, the LEAP-I study demonstrated high retention (83% female v 42% males) with excellent engagement and feedback from its female participants, yet caution was observed around engaging in a mixed exercised programme with men [16]. Women have traditionally been underserved in research and policy, yet multiple sources cite women as the fastest growing homeless demographic [23]. 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 evaluate the feasibility and impact of exercise with protein supplementation, delivered with a low threshold and trauma informed approach, on physical functioning and frailty outcomes in a group of (non-geriatric) women experiencing homelessness and addiction challenges, through the delivery of an exercise intervention, followed by qualitative interviews. 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 function, 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.
Materials and methods
Study design, setting and time frame
This single-arm quantitatively driven, sequential mixed-methods feasibility study will take place in Jane’s Place, Merchants Quay Ireland (MQI), a five day per week drop-in day-service centre in Dublin city centre, which provides medical and support services for socially excluded 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. This study has received ethical approval from the Faculty of Health Sciences, Trinity College Dublin on Jan 18th 2024 (Ethical Approval Reference Number: 211202).
Study population, eligibility criteria and recruitment strategy
Study population.
This study will include a non-geriatric population of women who attend Jane’s Place in Dublin city centre. These women are socially excluded, many with multiple disadvantage and complex needs and many experiencing homelessness, addiction and mental health challenges.
Eligibility criteria.
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.
- ➢ Women with a confirmed pregnancy.
Recruitment strategy.
All potential participants will be provided with a participant information leaflet (PIL) detailing the purpose of the data collection, potential risks and benefits and data protection rights. Where possible a seven-day gap, between receipt of the PIL and obtaining consent, will be provided to allow people time to consider participation. However, if it is their preference to be seen at an earlier and more convenient time this will be facilitated due to the innocuous nature of the evaluation.
Once the research physiotherapist is satisfied that the participant has read and fully understands the PIL, they will proceed to obtain written informed consent. Obtaining consent will take place at the first face to face interaction with the participant prior to commencement of the assessment. The written consent informs participants that they are permitted to withdraw from the study at any time. They will be provided with their own copy of this consent form and PIL with their own signature and that of the research physiotherapist.
Stakeholder engagement.
Recommendations from the linked LEAP II trial [17] included health education and awareness workshops preceding exercise interventions to enhance health literacy, target lifestyle behavioural change and improve retention rates. Prior to the LEAP-W programme, a number of exercise workshops will be delivered for staff and service users in Jane’s Place. Feedback from this stakeholder engagement will inform the design of the intervention.
Primary outcome. The primary outcome is feasibility which will be measured by recruitment numbers, retention rate, adherence to the exercise programme and protein supplement, programme acceptability and adverse events (Table 1).
Secondary outcomes
Secondary outcomes will measure physical function, frailty and nutritional status, pain and self-reported health status using a broad test battery outlined in Table 2.
1. Strength and muscular mass: Muscle strength will be measured, using a Jamar Digital Hand Dynamometer, while sitting with the elbow flexed at 90°, the forearm mid-prone, the wrist in neutral and the hand unsupported [27, 28]. Results will be compared to normative reference values [38]. Two measurements will be recorded and also used for the SHARE-Frailty Instrument (FI) assessment [33].
Mid-calf circumference girth will be evaluated as this measure correlates with appendicular muscular mass [39]. This will be measured using a flexible tape measure at the level of the largest circumference of the calf. Measurements will be compared to gendered cut-off values [40]. Mid-arm muscle circumference reflects both muscle mass and caloric and protein adequacy and may be used to signify wasting or malnutrition [41]. This test has been recommended in situations where lower limb swelling is present [42]. The maximum upper arm muscular mass will be measured using a flexible tape measure. These results will be compared to global reference values [43].
2. Physical performance and lower extremity physical function:
This will be measured using the following physical performance measures:
- The 10m Walk Test (10mWT). This test measures gait speed and functional mobility and is recorded in m/s. Gait speed is calculated as total distance/time [31].
- The 2 Minute Walk Test (2MWT). This test of self-paced walking ability and functional capacity assesses a participants’ ability to walk unaided over a 15m distance, as fast as possible, for two minutes. Rest breaks are permitted, and the distance covered is measured [30].
- The Chair Stand Test (CST). This tests lower limb strength and endurance and records the total number of sit to stand repetitions performed in 30 seconds [29].
- The Single Leg Stance Test (SLST). This balance test is performed on each leg. The participant is timed standing unassisted on one leg, with eyes open and hands placed on the hips [31].
3. Frailty: Frailty will be assessed using the Clinical Frailty Scale (CFS) [6] and the SHARE-Frailty Instrument (FI) [33]. The CFS is validated for people over 65 years. It is assessed by the tester. Each point on the scale correlates with a level of frailty and a visual chart aids classification from 1 (very fit) to 9 (terminally ill). Higher scores indicate higher levels of frailty. The SHARE-FI is validated for people over 50 years [33]. It consists of four brief questions related to the following variables: exhaustion, loss of appetite, walking difficulties and low physical activity, and grip strength measurement. The five results are entered into a freely available web calculator to generate a frailty score and a frailty category of non-frail, pre-frail and frail is also generated. A minor modification was made to the terminology of the SHARE-FI to reflect the real-world experiences of this population.
4. Nutritional status will be assessed using the Mini-nutritional assessment (MNA) which assesses the risk of malnutrition [34]. The short form of the MNA (MNA-SF) [35] is an efficient screening tool consisting of six questions on food intake, weight loss, mobility, psychological stress, or acute disease, the presence of dementia or depression, and body mass index (BMI). The maximum score for this part is equal to 14. A score of 12 or higher indicates a normal nutritional status thus excluding malnutrition and/or risk of malnutrition. The terminology of two of the questions of the MNA (regarding acuity of illness and psychological stress) were slightly modified for the purposes of evaluation of this population in this setting.
5. Pain: Each participant will be asked if they are experiencing pain and will be questioned about its location and duration. Pain severity will be assessed using the Numerical Rating Scale (NRS) [36]. The NRS is a unidimensional measure of pain intensity from 0–10, with 0 being zero pain and 10 the worst pain imaginable.
6. Short-Form 12 (SF-12) The SF-12 V2 is a self-report measure of health used across age, disease, and treatment groups [37]. It uses eight domains including physical and social activities, pain, mental health, emotional health, vitality and general health perceptions to measure health. The tester will read and complete the 12-question survey with the participant. Results will be entered into a software program provided by the licensing company QualityMetric and two summary scores, mental health (MCS12) and physical health (PCS12) will be generated.
The assessor will document any issues with terminology of the outcome measures utilised, difficulties with completion or floor or ceiling effects reached, as these instruments were designed with geriatric populations in mind.
Using a bespoke data collection form, the following demographic data will also be collected: age, gender, ethnicity, living arrangement and environment, highest level of education, marital status, employment status, history of incarceration, history of addiction, self-reported health, and medical history (S1 File and Fig 1).
Intervention.
The intervention will involve a 10-week low threshold, trauma informed exercise intervention (including a twice weekly exercise class with protein supplementation and a once weekly outdoor ‘Park Walk’), delivered over 12 weeks to enable flexibility and maximum participation. An aim of this research approach is to enhance the programmes accessibility by providing flexibility and a level of awareness and understanding of past trauma, an approach which is recommended for people who have experienced chronic or complex trauma [44]. The LEAP-II trial, a linked study previously conducted a similar 12-week intervention [17]. While the results demonstrated evidence of effectiveness, the majority (91%) of those who attended regularly did not complete more than 10 weeks of the intervention. Behm et al (2023), proposed a minimal dose of once weekly multi-joint resistance training, with at least 6–15 repetitions using loads between 30–80% of one repetition maximum for 8–12 weeks to achieve a strengthening effect in untrained individuals [45]. Given that 10 weeks marks the midpoint of this finding, a pragmatic decision was made to shorten the duration of this feasibility study to prioritise and encourage increased retention and participation in this ‘hard to reach’ population who are known to engage poorly with mainstream services.
The intervention will be delivered by two research physiotherapists who will adhere to all safety procedures. Flexibility will be facilitated with the provision of a four-week window for pre-intervention evaluations prior to commencement of the programme. Using a trauma-informed lens [46] flexibly arranged group or one-to one sessions will be delivered based on participant preference. Exercise programming strategies and variables are based on our earlier work (LEAP-I and LEAP-II trials) [16, 17] and also informed by prior stakeholder involvement from people with lived experience. The exercise classes will be multi-modal, with a primary focus on strength and based on core set of resistance exercises (Table 3). Aerobic, balance and flexibility work will be integrated into the class and the exercises will be individualised based on initial assessment results and presentation of participants. Using a gender-based perspective, the following considerations and adaptions will be built into the class; (i) core-stability exercises to target pelvic floor and/or abdominal muscle weakness, (ii) bone building exercises to target peri-and postmenopausal bone loss and (iii) age-associated muscle mass loss. Music, dance and fun orientated physical activity games, an important feature of aforementioned linked studies, will be incorporated to optimize enjoyment and self-esteem. These features are incorporated to offer choice and enable empowerment in respect of a trauma informed approach, while carefully considering the exercise prescription parameters outlined above [45]. Borg’s Rate of Perceived Exertion Scale will be used to monitor effort and scale the intensity of the workout [47]. To promote post-exercise muscle protein synthesis, a nutritional supplement (200ml pre-prepared ‘protein shake’, Fresubin) which consists of 20g of protein will be offered immediately post exercise. The ‘Park Walk’ will focus on the aerobic component of the intervention, using open green space to maximise physical and mental health outcomes. It will be a flexibly arranged 20–30-minute self-paced group or one-to-one walk. To build sustainability beyond the ten-week programme brief health promoting and physical activity educational interventions will be included in the exercise class setting to empower people to engage in unsupervised exercise following the study. As per routine procedure in the centre, which incorporates frequent reminders regarding upcoming appointments or events, phone messages will be incorporated to remind participants of the weekly schedule.
Each session will commence with a warm-up and will be completed with a cool down and stretch of the major muscle groups.
Qualitative data.
Following the intervention one-to-one in-person semi-structured exit interviews will be conducted to enable participants to share their feedback and express their views, in order to enhance the understanding of behaviours, adherence and retention challenges and to provide insights for future programmes in this area [48] (S2 File). In order to gain a deep understanding of a complex phenomenon, multiple perspectives will be sought using purposive sampling, selecting participants who provided informed consent and completed at a minimum the initial pre-intervention evaluation as well as key stakeholders involved in service provision to women who attend the low threshold services in MQI. Data from 20 participants will be sought. The interviews will be audio-recorded in a private room in Jane’s Place, by the lead researcher FK, using a Philips Dictaphone (DVT2050). Data will be immediately transferred to Sharepoint, a secure cloud-based system and then transcribed verbatim by FK. Member checking will be utilised. FK has knowledge and experience of quantitative and qualitative research methodology.
Braun and Clarke’s reflexive thematic analysis will be used to interpret the qualitative data [49, 50]. An inductive approach will be utilised, guided by the 6-step framework. This will include 1) familiarisation with the data, 2) coding, 3) generating themes, 4) reviewing themes, 5) defining themes, and 6) writing up. Qualitative data will be coded manually by FK and software will not be used. An external validator will assist in coding, theme generation, review, and definition. FK will conduct the narrative which will include integration with the quantitative data.
Using a hybrid design, the quantitative and qualitative data will be collected sequentially, as described, and the results will be analysed and presented separately [51, 52].
Sample size.
A sample size calculation was conducted on the statistical package R, based on an expected adherence of 60%, a minimal acceptable adherence of 45% and a power of 80%, which indicated that a target sample size of 68 would be required. Due to the novelty of this study, the challenges of recruitment in this ‘hard to reach’ population and the feasibility focus of this study, while 68 will be the recruitment target, a minimal of 24 will be sought [53].
Data collection and management
Analytic plan
All data will be pseudonymised at point of entry into excel spreadsheets and then transferred into IBM SPSS V28 for analysis. For quantitative data, nominal or ordinal variables will be reported as frequencies and percentages. Continuous variables will be summarised as mean and standard deviation if normally distributed and median and inter-quartile range if non-normally distributed. Data will be tested for normality using the Kolmogorov–Smirnov/Shapiro Wilk test and will be compared across timepoints using the general linear model procedure (normally distributed data) and the Friedman’s test (non-normally distributed data). Chi-squared t-tests will be used where appropriate and some data may be categorised to investigate relationships between variables. Exploratory regression models will be developed to explore correlates and predictors of frailty and poor physical functioning. For the qualitative data, Braun and Clarke thematic analysis methodology will be employed to provide an in-depth analysis of the exit interview data [50]. A p-value of <0.05 will be considered significant. To account for multiple comparisons, we will apply a Bonferroni correction by dividing the significance level by the number of tests conducted.
Discussion
Poor physical functioning and frailty has been demonstrated in younger populations who suffer from health disparities and an extreme form of social exclusion, such as PEH and addiction challenges [12, 13, 54]. Women who experience homelessness and addiction are especially vulnerable and have unique and complex needs which require a targeted and gender-sensitive approach. Little is known about frailty-focussed interventions in this population who are often excluded from services and research (18). However, this population have engaged well in two previous linked studies (LEAP-I and II). This study aims to address the research gap by providing a targeted exercise intervention to women experiencing homelessness and addiction challenges, thereby providing a gendered dimension, with gendered sensitivity. Its findings will guide clinicians and policy makers in implementing targeted interventions to assist in improving health outcomes in societies most marginalised and vulnerable groups.
Acknowledgments
The authors wish to extend their gratitude to the staff of Jane’s Place, MQI who are helping to recruit participants.
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