Effect of a Community-based Exercise Programme on Physical, Psychosocial and Economic Health Outcomes in Individuals Living With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- General Health Questionnaire -Short-Form-12 (SF12)
研究概览
简要总结
Physical activity is known to be beneficial for supporting health and wellbeing. A number of schemes and strategies have been developed to improve uptake of physical activity in the United Kingdom (UK) population, including the 'Everybody active, every day' framework. This framework includes recommendations for referral from a healthcare professional for people to become more active. For those with an existing health condition or other risk factors that could lead to health problems, such referrals may be to an 'exercise referral scheme' (ERS). However, there are often limited opportunities for individuals diagnosed with stroke and/or a Transient Ischaemic Attack (TIA to engage in rigorously monitored, exercise and behaviour change opportunities once they have been discharged from the National Health Service (NHS). In Winchester, General Practitioners (GPs) refer approximately 10 to 20 stroke/TIA patients to the Winchester City Council led exercise referral scheme each year, despite the local trust (Hampshire Hospitals NHS Foundation Trust; HHFT) diagnosing approx. 1000 cases each year. With limited time and resources for GPs to effectively refer eligible patients to the programme, greater engagement with NHS hospitals may be necessary to increase the referral and uptake of such programmes. Accordingly, the Health Enhancing Lifestyle Programme (HELP) Hampshire Stroke Clinic (www.helphampshire.co.uk) was launched in March 2019 and provides individuals who have experienced a stroke with various community-based, accessible, group-focused exercise opportunities. Referrals primarily come from consultants, physiotherapists and occupational therapists from HHFT.
The purpose of this study is to document outcomes (physical, psycho-social, economic) to indicate the effectiveness of the HELP Hampshire exercise referral scheme.
详细描述
Design:
The present study will be a controlled trial without randomisation. This is considered appropriate by the research team given the potential for participants of the exercise group to experience improved health outcomes compared with those assigned to a control group (receiving usual clinical care, who elect not to attend exercise classes). Accordingly, all individuals diagnosed with stroke from Hampshire Hospitals NHS Foundation Trust, who meet inclusion criteria (i.e. eligible to engage in a stroke rehabilitation programme) will be presented with an equal opportunity to attend low-cost, community-based exercise classes. Health-related quality of life, with researchers considering participation against various measures of physical and psycho-social health outcomes will be assessed at baseline, post-intervention (following possible engagement in 12 weeks of exercise classes) and at 6-month follow-up. Attendance to exercise classes will be optional but will be monitored to assess exercise adherence. Participants electing not to attend exercise classes will form a control group, providing evidence of the usual care pathway, and will also be asked to attend the post-intervention and 6-month follow-up assessment.
Exercise classes will be provided through the Health Enhancing Lifestyle Programme (HELP) Hampshire Stoke Clinic. The HELP clinic is a community-based initiative that signposts and provides individuals who have experienced stroke and/or TIA to various accessible and affordable exercise and educational opportunities and is led by the University of Winchester in collaboration with the Hampshire Hospitals NHS Foundation Trust (HHFT) and Hobbs Rehabilitation, a specialist, independent, neuro-physiotherapy provider. As the HELP Hampshire Stroke Clinic provides a service to the stroke community alongside the usual care pathway, some individuals referred to the clinic may choose to participate in the exercise classes but not to participate in the study. This is a fundamental right of the individual. Such individuals will not be disadvantaged in anyway as it will not impact the opportunity for them to access the exercise classes, nor will it affect the nature of the exercises or any other part of the service provided by the HELP Hampshire Stoke Clinic.
The research team have discussed the design of the present study with the clinical team at HHFT, including stoke consultants, occupational therapists and physiotherapists, and neuro-physiotherapists from Hobbs Rehabilitation. The study has also been discussed at a Patient and Public Involvement (PPI) meeting, and with people who are currently engaging in the HELP Hampshire Stroke Clinic. The project has been discussed with Prof Maria Stokes and Dr Danielle Lambrick from the School of Health Sciences at the University of Southampton.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for stroke rehabilitation as determined by an appropriate healthcare professional (stroke consultant, physiotherapist).
- •Clinical diagnosis of a TIA (via the ABCD2) or stroke (NIH Stroke Severity Scale) by a member of the clinical team at HHFT.
- •Willingness to take part in HELP Hampshire Stroke Clinic or control
- •Cognitive and communication capacity to sufficiently participate in the study
排除标准
- •Age >90 years
- •Contraindications to moderate to vigorous physical activity including;
- •Acute or uncontrolled heart failure
- •Unstable or uncontrolled angina
- •Uncontrolled cardiac dysrhythmia causing symptoms or haemodynamic compromise
- •Symptomatic severe aortic stenosis
研究组 & 干预措施
Exercise
Participants have the opportunity to engage in face-to-face and/or online exercise classes
干预措施: Community Programme (Behavioral)
Usual care control
Participants continue to engage with usual care provided on discharge from the hospital.
结局指标
主要结局
General Health Questionnaire -Short-Form-12 (SF12)
时间窗: Change from baseline to up to 12 weeks and 36 weeks after baseline
12-item questionnaire that assesses quality of life. Higher scores mean better general health. Scores range from 0 to 100.
Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)
时间窗: Change from baseline to up to 12 weeks and 36 weeks after baseline
5-item questionnaire that assesses quality of life. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension
次要结局
- Stages of Change for Exercise Participation(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- International Physical Activity Questionnaire Short-Form(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Weight(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Height(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Loneliness and Social Isolation(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Body Mass Index(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Depression Anxiety and Stress Scale (DASS)-9(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Social Network Questionnaire(Baseline)
- Blood pressure(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)
- Sit-to-Stand task(Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline)