Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-02-06
Brief Title:
Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction
Sponsor:
University of Dublin Trinity College
Organization:
University of Dublin Trinity College
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEAP-W
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
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
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 andor 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 andor 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 Borgs 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-SmirnovShapiro Wilk test and will be compared across timepoints using the general linear model procedure normally distributed data and the Friedmans 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 005 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
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 andor 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 andor 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 Borgs 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-SmirnovShapiro Wilk test and will be compared across timepoints using the general linear model procedure normally distributed data and the Friedmans 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None