Clinical and Cost-effectiveness of a Co-developed, Evidence-based Physical Activity Referral Scheme for the Treatment and Prevention of Health Conditions: a Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in cardiorespiratory fitness
研究概览
简要总结
The study will evaluate the effectiveness of a co-developed exercise referral scheme. Participants will be recruited to one of three groups 1. Co-developed exercise referral scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention). The study will measure effectiveness by observing change in cardiorespiratory fitness at 12 weeks. Intervention cost-effectiveness will also be evaluated at 3 months follow-up using objective physical activity data.
详细描述
Evidence of effectiveness for UK exercise referral is unclear. This representation has been deemed an unfair assessment of its potential to impact public health. This is due to systematic review evidence that reports evaluations of exercise referral interventions that are not evidence-based or underpinned by behaviour change theory.
This evaluation is the third phase of a project that aims to co-develop (Phase 1), pilot (phase 2) and evaluate (phase 3) an evidence-based exercise referral scheme. This approach is underpinned by the Medical Research Council guidance for complex interventions.
Through co-development work with a multidisciplinary group of researchers and local stakeholders and subsequent pilot work, it is hypothesised that the co-developed, evidence-based intervention will have improved chances of implementation success, and therefore, clinical effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Post hoc data analysis will be blinded via an independent coding method for condition and time frame (i.e. pre-post measures).
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
- •18 years or older and have a health-related risk factor (e.g. high blood pressure, hyperglycaemia, obesity etc.) or a health condition (diabetes, cardiovascular disease, anxiety, depression etc.) that may be alleviated by increasing current PA levels.
排除标准
- •Uncontrolled health-conditions (Cardiac, metabolic, respiratory etc.) and/or any recent traumatic events (e.g. myocardial infarction).
- •Unstable angina or aortic stenosis.
- •Severe psychological or neurological conditions.
- •Participation in an ERS at any location other than the research centres (at the time of recruitment).
研究组 & 干预措施
Co-developed referral scheme
A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility.
干预措施: Physical activity referral scheme (Behavioral)
Usual care referral scheme
Comparative, usual care exercise referral scheme.
干预措施: Usual care exercise referral scheme (Behavioral)
No treatment control
Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments).
结局指标
主要结局
Change in cardiorespiratory fitness
时间窗: Baseline and week 12.
Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.
次要结局
- Change in psychological wellbeing(Baseline, week 12, and 6 months.)
- Change in triglycerides(Baseline and week 12.)
- Change in objective physical activity levels(Baseline, week 12, and 6 months)
- Change in total cholesterol(Baseline and week 12.)
- Change in plasma glucose(Baseline and week 12.)
- Change in flow-mediated dilation(Baseline and week 12.)
- Attendance at consultations(Week 1, 4, 8, 12, and 18)
- Attendance at fitness centre(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. Months 4, 5 and 6)
- Fidelity - consultation attendance(Week 18)
- Change in carotid vasoreactivity(Baseline and week 12.)
- Fidelity - consultation communication strategies(Week 1, 4, 8, 12, and 18)
- Change in health-related quality of life measure(Baseline, week 12, and 6 months.)
- Loss in revenue costs(Week 18)
- Change in self-reported physical activity(Baseline, week 12, and 6 months.)
- Change in patient health care utilisation costs(Baseline and 6 months)
- Intervention operating and set up costs(Week 18)
- Change in patient costs(Baseline, Week 12 and 6 months)
研究者
Paula Watson
Senior Lecturer
Liverpool John Moores University