Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction.

NCT06264895 | Active Not Recruiting

• 1 other identifier: Trinity College Dublin 211202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Exclusion; Chronic Disease; Physical Disability; Addiction

Outcome Measures

Primary Outcomes (3)

• Recruitment

  Number recruited to the study

  12 weeks

• Retention

  Number of repeat visits

  12 weeks

• Adverse events

  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.

  12 weeks

Secondary Outcomes (11)

• Hand grip dynamometry

  up to 10 weeks

• Limb circumference

  up to 10 weeks

• 10 Metre Walk Test

  up to 10 weeks

• 2 Minute Walk Test

  up to 10 weeks

• The Chair Stand Test

  up to 10 weeks

Study Arms (1)

Evaluation of an exercise intervention for women experiencing homelessness and addiction.

EXPERIMENTAL

A 3 times weekly exercise intervention with protein supplementation will be delivered to all study participants for 10 weeks.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

three times weekly exercise intervention with protein supplementation

Evaluation of an exercise intervention for women experiencing homelessness and addiction.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: any person identifying as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (18-65 years) accessing services in Jane's Place who consent to participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Trinity College Dublin, University of Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Social Isolation; Chronic Disease; Behavior, Addictive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julie Broderick, PhD

  Trinity College, University of Dublin, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Julie Broderick, Assistant Professor, Head of Discipline of Physiotherapy

Model Details: single -arm longitudinal cohort study

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: February 26, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

IE (1)