Evaluation of a Physical Activity Referral Scheme

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490747
• Other study ID #: SPS-17-01
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: September 2019
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Physical activity referral scheme
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.
• Usual care exercise referral scheme
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.

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool	Merseyside

Sponsors (6)

Lead Sponsor	Collaborator
Paula Watson	Brock University, Radboud University, University of Bath, University of Gloucestershire, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in exercise motivation	The Behavioural Regulation in Exercise Questionnaire (BREQ-2, Markland & Tobin, 2004) plus 4 additional items (Wilson et al., 2006a) will be used to assess exercise motivation. The BREQ-2 is a widely-used instrument comprised of 19 items describing reasons why people exercise (e.g. "I think exercising is a waste of time"; "I feel ashamed when I miss an exercise session"; "I exercise because it's fun"). Participants answer on a likert scale of 0 (not true for me) to 4 (very true to me) to indicate how true each item is for them.	Baseline, week 12, and 6 months.
Other	Change in psychological needs satisfaction	Psychological need satisfaction will be measured using the Psychological Need Satisfaction in Exercise Scale (PNSE, Wilson et al., 2006b). The PNSE is an 18-item instrument designed to measure participants' perceived autonomy (e.g. "I feel free to exercise in my own way"), competence (e.g. "I feel capable of completing exercises that are challenging to me") and relatedness (e.g. "I feel connected to the people who I interact with while we exercise together") in an exercise context. Participants are asked to answer on a 6-point likert scale (1 = false, 6 = true) to indicate how they typically feel when they exercise.	Baseline, week 12, and 6 months.
Other	Change in perceived needs support	Needs support will be measured using a 15-item needs support (NS) tool developed by Markland and Tobin (2010) to measure the extent to which participants perceive their exercise instructors provide support for autonomy, structure (linked to competence) and involvement (linked to relatedness).	Baseline, week 12, and 6 months.
Other	Change in intentions to engage in physical activity	Three items developed by Edmunds et al. (2007) will be used to assess patients' intentions to engage in PA (e.g. "I plan to regularly engage in PA during the next 3 months").	Baseline, week 12, and 6 months.
Other	Patient focus groups - intervention	Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the intervention centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.	Week 12
Other	Patient focus groups - usual care	Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the usual care centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.	Week 12
Other	Exercise referral practitioner (ERP) interviews (intervention group only)	ERPs from the intervention centre only will take part in a semi-structured interview (after over half of patients have reached the 18-week point). The interviews will aim to explore the acceptability of the co-developed intervention, any challenges of delivery, and areas that require further development etc.	Week 18
Primary	Change in cardiorespiratory fitness	Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.	Baseline and week 12.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	Loss in revenue costs	Captured via telephone interview with fitness centre manager and/or coordinators (questions have been used in previous research).	Week 18
Secondary	Change in patient costs	Captured via patient questionnaire during lab testing (questions adapted from validated questionnaire).	Baseline, Week 12 and 6 months
Secondary	Change in patient health care utilisation costs	Captured via questionnaire (questions adapted from validated questionnaire).	Baseline and 6 months