Evaluation of a Physical Activity Referral Scheme

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Cardiovascular Risk Factor, Diabetes Mellitus, Type 2, Depression, Musculoskeletal Injury, Cardiovascular Diseases, Cancer, Obesity, Metabolic Syndrome, Physical Activity

Intervention / Treatment
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* Behavioral: Physical activity referral scheme
* Behavioral: Usual care exercise referral scheme


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 3 arm quasi-experimental trial 1. Co-developed scheme 2. Usual care 3. No treatment control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-developed referral scheme<br>A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility. | Behavioral: Physical activity referral scheme<br>* An 18-week physical activity referral scheme co-developed by a local multidisciplinary stakeholder group. Behaviour change support underpinned by Self-Determination Theory (Ryan & Deci, 2000) will be provided by an exercise referral practitioner at weeks 1,4,8,12 and 18 to facilitate increased physical activity levels. Patients will be supported to develop a tailored programme of physical activity that may involve use of the fitness centre facilities (e.g. swimming, group classes, gymnasium use), participation in community-based initiatives, and changes to habitual physical activity. Focus on promoting patient autonomy and tailoring activities to patient's preferences and needs. Subsidised access to fitness centre facilities for first 12 weeks.<br>|
| Active Comparator: Usual care referral scheme<br>Comparative, usual care exercise referral scheme. | Behavioral: Usual care exercise referral scheme<br>* A comparative usual care exercise referral scheme that includes fitness centre based activities (e.g. swimming, group classes, gymnasium use). Patients meet an exercise referral practitioner at their induction (week 1) and week 12 (post scheme). Patients are typically prescribed a gym-based, 12-week programme. Subsidised access to fitness centre facilities for 12 weeks.<br>|
| No Intervention: No treatment control<br>Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory fitness | Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram. | Baseline and week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective physical activity levels | Objective physical activity levels will be analysed using a hip worn accelerometer (ActiGraph GT3X). 7-day monitoring periods will recorded at three time points. During the 7-day monitoring period, each participant will complete a diary to record hours of use and to distinguish between work and leisure hours. | Baseline, week 12, and 6 months | 
| Change in flow-mediated dilation | Endothelium dependent vasodilatation of the brachial arteries will be examined using ultrasound. Brachial artery baseline diameter and blood flow will be assessed in one arm. An ultrasound probe is placed on the bicep for 1 minute before a blood pressure cuff (placed around the forearm) is inflated to suprasystolic pressure ( 220 mmHg) for 5 minutes. Immediately after the cuff is deflated, changes in arterial diameter and flow will be assessed continuously for 3 minutes using the ultrasound probe. Ultrasound data will then be analysed post hoc. | Baseline and week 12. | 
| Change in carotid vasoreactivity | The carotid vasoreactivity (cold pressor) test will measure the carotid artery's response to a stimulus. Similar to the flow-mediated dilation procedure, an ultrasound probe will be placed on the patient's left side of their neck, positioned in such a way to allow a clear image of the right common carotid artery to be displayed on the ultrasound monitor screen. The cold pressor procedure involves submersion of the left hand to wrist in ice slush for 180-seconds. Ultrasound data will then be analysed post hoc. | Baseline and week 12. | 
| Change in total cholesterol | A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue. | Baseline and week 12. | 
| Change in plasma glucose | A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue. | Baseline and week 12. | 
| Change in triglycerides | A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue. | Baseline and week 12. | 
| Change in self-reported physical activity | Patients' perceived physical activity levels will be recorded with the short version of the International Physical Activity Questionnaire (IPAQ, Craig et al., 2003). The short-IPAQ is a 7-day recall self-administered tool that measures intensity, frequency and duration of physical activity and provides a total estimate of energy expenditure. A total score of MET-minutes/day/week and sedentary behaviour minutes/day/week will be calculated according to the IPAQ scoring protocol. | Baseline, week 12, and 6 months. | 
| Change in psychological wellbeing | Psychological wellbeing will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS, Tennant et al., 2007). WEMWBS is a 14-item positively worded instrument containing items related to psychological functioning (e.g. I've been thinking clearly) and subjective well-being (e.g. I've been feeling cheerful). Participants are asked to rate on a Likert scale of 1 (none of the time) to 5 (all of the time) how well each statement describes their experiences over the last two weeks. | Baseline, week 12, and 6 months. | 
| Attendance at consultations | Patient attendance records will be collected by ERPs at the following time-points: Intervention centre: 1, 4,8,12 and 18 weeks; Usual care centre: 1 and 12 weeks. | Week 1, 4, 8, 12, and 18 | 
| Attendance at fitness centre | The number of times patients sign in at the fitness centre to go to either the gym or a class will be recorded on a weekly basis for weeks 1 to 12, then on a monthly basis up to 6 months. This information is automatically recorded at fitness centres when patients visit. | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. Months 4, 5 and 6 | 
| Fidelity - consultation attendance | ERPs from both intervention and usual care centres will be asked to monitor the number of consultations offered (measured by appointment bookings or records of appointments offered but declined by participants), and the number of consultations conducted for each patient. | Week 18 | 
| Fidelity - consultation communication strategies | A random sample of ERS inductions from both intervention and usual care centres (approx 10 per centre) plus a random sample of 4, 8, 12 and 18-week consultations from the intervention centre only will be audio-recorded and coded for the use of needs-supportive communication strategies (using a coding manual developed through a previous pilot study (REF 16/WA/0231)). In addition, all intervention centre recordings will be coded for fidelity to an agreed protocol, e.g. asking required questions about physical activity, setting an action plan, giving out patient log book etc. | Week 1, 4, 8, 12, and 18 | 
| Change in health-related quality of life measure | Participants' change in health-related quality of life (HRQoL) will be measured at baseline, 12 weeks, and 6 months. The EQ-5D will be used, this is a validated tool for measuring HRQoL. This tool has been applied successfully in a recent UK trial-based economic evaluation of exercise referral schemes (Edwards et al. 2013). | Baseline, week 12, and 6 months. | 
| Intervention operating and set up costs | Captured via telephone interview with Exercise Referral Scheme Personnel from (organisation e.g. local authority/ fitness centre/ research institute; questions adapted from validated questionnaire). | Week 18 | 
| Loss in revenue costs | Captured via telephone interview with fitness centre manager and/or coordinators (questions have been used in previous research). | Week 18 | 
| Change in patient costs | Captured via patient questionnaire during lab testing (questions adapted from validated questionnaire). | Baseline, Week 12 and 6 months | 
| Change in patient health care utilisation costs | Captured via questionnaire (questions adapted from validated questionnaire). | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Pragmatic Evaluation, Exercise Referral, Mixed-methods, Behaviour Change, Intervention