A Feasibility Study to Explore the Role of Exercise and Nutrition to Target Frailty in People With Problematic Substance Use and Homelessness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
Background: People who are homeless are more likely to experience poor mental health and addiction as well as suffering from non-communicable diseases. There is evidence of frailty and accelerated physical ageing among people experiencing homelessness. Appropriate physical rehabilitation and nutritional supplementation strategies can stabilize or reverse frailty and general physical decline, but it is not known how this type of intervention would work in practice in this population.
Aim: To evaluate the feasibility and preliminary efficacy of a physical rehabilitation drop in intervention with protein supplementation to target physical functioning and frailty in people with problematic substance use who are experiencing homelessness.
Methods: The intervention will consist of a 12-week low threshold physical rehabilitation program with protein supplementation. Participants will be service users of the Advance Ballyfermot Project, a day services center for people who are homeless and have active addiction issues. Primary outcomes will be feasibility including numbers recruited, retention of participants and number of repeat visits. Any adverse events will be recorded. Secondary outcomes will be strength and muscular mass, physical performance and lower extremity physical function, pain, frailty and nutritional status.
详细描述
This single arm feasibility cohort study is taking place in the Advance Ballyfermot Project, located in Dublin. This centre provides a 5-day a week meal service as well as drug related services for people with active addiction issues who are temporarily housed or homeless. A dedicated exercise room has been allocated for the duration of the intervention period. This study has received ethical approval from the Faculty of Health Sciences REC at Trinity College Dublin (Ethical Approval Reference Number: 211202).
The aim of the study is to be as low threshold as possible. This means that minimal constraints are put in place to access the intervention. In order to be as pragmatic as possible in terms of inclusion criteria, all clients (>18 years) accessing services from The Advance Ballyfermot Project who consent to study participation can be included in this study. Only participants with acute problematic behavioral issues or confusion, are in an agitated state or have major physical problems ,(medical or orthopedic) which would preclude ability to safely participate in the exercise class will be excluded from study participation. Participants with a confirmed pregnancy will also be excluded.
The intervention will consist of a twice weekly (for 12 weeks, from November 2022 to February 2023) exercise class with nutritional intervention and a once weekly 'Park Walk'. The intervention will be fully supervised and delivered by two research physiotherapists.
Each session will commence with a warm-up and stretch of the major muscles and will end with cool-down and stretch. The intensity of the workout will be managed by using the Borg Perceived Rate of Exertion (RPE) scale where participants will be advised to exercise at a rate of between 11 and 13 on the PRE scale, ie. between 'fairly light' to 'somewhat hard', where they find it hard to have a conversation but can comfortably continue to exercise.
In an attempt to build sustainability beyond the life cycle of the project, participants will also be educated about exercise and available local resources where possible. Clients will be invited and encouraged to return weekly to continue with the exercise intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recruitment
时间窗: October to December 2022
Number recruited to study
Adverse events
时间窗: Through to study completion, up to 12 weeks
Any injuries or incidence will be recorded
Adherence
时间窗: Through to study completion, up to 12 weeks
Number of repeat visits
次要结局
- Numerical Rating Scale(Baseline and 12 weeks)
- The Two Minute Walk Test(Baseline and 12 weeks)
- Mini-nutritional assessment(Baseline and 12 weeks)
- Hand-grip dynamometer(Baseline and 12 weeks)
- The 10 Metre Walk Test(Baseline and 12 weeks)
- Limb circumference measurement(Baseline and 12 weeks)
- Clinical Frailty Scale(Baseline and 12 weeks)
- Body mass Index(Baseline and 12 weeks)
- The 30-Second Chair Stand Test(Baseline and 12 weeks)
- SHARE Frailty instrument(Baseline and 12 weeks)
- Self-report open ended questions(Baseline and 12 weeks)
- Single Leg Stance Test(Bseline and 12 weeks)
- Short Form 12(Baseline and 12 weeks)
研究者
Julie Broderick
Assistant Professor
University of Dublin, Trinity College