Clinical trial NCT03490747: Evaluation of a Physical Activity Referral Scheme
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Diabetes Mellitus, Type 2
Anxiety
Depression
Musculoskeletal Injury
Cardiovascular Diseases
Cancer
Obesity
Metabolic Syndrome
Physical Activity
Keywords: Physical Activity
Pragmatic Evaluation
Exercise Referral
Mixed-methods
Behaviour Change
Intervention
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: University of Bath
name: University of Gloucestershire
name: University of Liverpool
name: Brock University
name: Radboud University Medical Center
First posted: 2018-04-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 arm quasi-experimental trial

1. Co-developed scheme 2. Usual care 3. No treatment control
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and week 12.
Secondary outcomes:
measure: Change in objective physical activity levels
timeFrame: Baseline, week 12, and 6 months
measure: Change in flow-mediated dilation
timeFrame: Baseline and week 12.
measure: Change in carotid vasoreactivity
timeFrame: Baseline and week 12.
measure: Change in total cholesterol
timeFrame: Baseline and week 12.
measure: Change in plasma glucose
timeFrame: Baseline and week 12.
measure: Change in triglycerides
timeFrame: Baseline and week 12.
measure: Change in self-reported physical activity
timeFrame: Baseline, week 12, and 6 months.
measure: Change in psychological wellbeing
timeFrame: Baseline, week 12, and 6 months.
measure: Attendance at consultations
timeFrame: Week 1, 4, 8, 12, and 18
measure: Attendance at fitness centre
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. Months 4, 5 and 6
measure: Fidelity - consultation attendance
timeFrame: Week 18
measure: Fidelity - consultation communication strategies
timeFrame: Week 1, 4, 8, 12, and 18
measure: Change in health-related quality of life measure
timeFrame: Baseline, week 12, and 6 months.
measure: Intervention operating and set up costs
timeFrame: Week 18
measure: Loss in revenue costs
timeFrame: Week 18
measure: Change in patient costs
timeFrame: Baseline, Week 12 and 6 months
measure: Change in patient health care utilisation costs
timeFrame: Baseline and 6 months
Other outcomes:
measure: Change in exercise motivation
timeFrame: Baseline, week 12, and 6 months.
measure: Change in psychological needs satisfaction
timeFrame: Baseline, week 12, and 6 months.
measure: Change in perceived needs support
timeFrame: Baseline, week 12, and 6 months.
measure: Change in intentions to engage in physical activity
timeFrame: Baseline, week 12, and 6 months.
measure: Patient focus groups - intervention
timeFrame: Week 12
measure: Patient focus groups - usual care
timeFrame: Week 12
measure: Exercise referral practitioner (ERP) interviews (intervention group only)
timeFrame: Week 18
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Paula M Watson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckley BJ, Thijssen DH, Murphy RC, Graves LE, Cochrane M, Gillison F, Crone D, Wilson PM, Whyte G, Watson PM. Pragmatic evaluation of a coproduced physical activity referral scheme: a UK quasi-experimental study. BMJ Open. 2020 Oct 1;10(10):e034580. doi: 10.1136/bmjopen-2019-034580.