Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06264895 |
Other study ID # |
Trinity College Dublin 211202 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 26, 2024 |
Est. completion date |
July 31, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of Dublin, Trinity College |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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:
1. To evaluate recruitment, retention and adherence rates, and any adverse effects of the
intervention.
2. To evaluate pre- and post-intervention levels of physical, nutritional and frailty
status, pain and general health status.
3. 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.
The 10-week intervention will involve a low threshold, three-times weekly exercise programme
(two exercise classes with protein supplementation and an outdoor 'Park Walk') delivered over
12 weeks to offer flexibility to participants. It will be delivered by two research
physiotherapists who will adhere to all safety procedures. Further flexibility will be
facilitated with the provision of a four-week window for pre-intervention evaluations prior
to commencement of the programme, and group or one-to one sessions will be delivered based on
participant preference. The exercise classes will be multi-modal, with a primary focus on
strength and based on core set of resistance exercises. 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 prior
linked studies, will be incorporated to optimize enjoyment and self-esteem. Borg's Rate of
Perceived Exertion Scale will be used to monitor effort and scale the intensity of the
workout. 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 green open 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. Following the intervention one-to-one
in-person exit interviews will be conducted to enable participants to provide feedback and
express personal views, in order to enhance the understanding of behaviours, adherence and
retention challenges and to provide insights for future programmes in this area. Interviews
will continue until 20 participants are seen or until data saturation is reached. The
interviews will be audio-recorded and transcribed verbatim and member checking will be
utilised.
Analytic plan: 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. A p-value of <0.05 will
be considered significant. For the qualitative data, Braun and Clarke thematic analysis
methodology will be employed to provide an in-depth analysis of the exit interview data.