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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Risk Factor
- Sponsor
- Paula Watson
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in cardiorespiratory fitness
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Paula Watson
Senior Lecturer
Liverpool John Moores University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Change in cardiorespiratory fitness
Time Frame: Baseline and week 12.
Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.
Secondary Outcomes
- 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)