Cardiovascular Risk FactorNCT03490747
Evaluation of a Physical Activity Referral Scheme
A study testing Physical activity referral scheme in people with Cardiovascular Risk Factor and Diabetes Mellitus, Type 2, run by Paula Watson at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor, Diabetes Mellitus, Type 2, Anxiety
- What is being tested?
- Physical activity referral scheme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 2AT
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Diabetes Mellitus, Type 2, Anxiety, Depression, Musculoskeletal Injury, Cardiovascular Diseases
- Being tested
- Physical activity referral scheme, Usual care exercise referral scheme
- Keywords
- Physical Activity, Pragmatic Evaluation, Exercise Referral, Mixed-methods, Behaviour Change, Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Anxiety Disorders, Depression, Cardiovascular Diseases, Neoplasms, Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity referral schemeBehavioural
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 schemeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Co-developed referral scheme | Experimental | A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility. Receives: Behavioral: Physical activity referral scheme |
| Usual care referral scheme | Active comparator | Comparative, usual care exercise referral scheme. Receives: Behavioral: Usual care exercise referral scheme |
| No treatment control | No intervention | Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.
Measured: Baseline and week 12.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Week 18
Loss in revenue costs
Captured via telephone interview with fitness centre manager and/or coordinators (questions have been used in previous research).
Measured: Week 18
Change in patient costs
Captured via patient questionnaire during lab testing (questions adapted from validated questionnaire).
Measured: Baseline, Week 12 and 6 months
Change in patient health care utilisation costs
Captured via questionnaire (questions adapted from validated questionnaire).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start12 Mar 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 3 arm quasi-experimental trial 1\. Co-developed scheme 2. Usual care 3. No treatment control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paula Watson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, University of Gloucestershire, University of Liverpool, Brock University, Radboud University Medical Center
- Responsible party
- Sponsor-investigator, Paula Watson, Liverpool John Moores University
- Investigators
- Paula M Watson, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490747
- Sponsor's protocol ID
- SPS-17-01
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33004383
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03490747
- Acronym / sponsor ID
- SPS-17-01
- Conditions
- Cardiovascular Risk Factor, Diabetes Mellitus, Type 2, Anxiety, Depression, Musculoskeletal Injury, Cardiovascular Diseases
- Keywords
- Physical Activity, Pragmatic Evaluation, Exercise Referral, Mixed-methods, Behaviour Change, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Paula WatsonUniversity, hospital or other
- Collaborators
- University of Bath, University of Gloucestershire, University of Liverpool, Brock University, Radboud University Medical Center
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arm quasi-experimental trial 1. Co-developed scheme 2. Usual care 3. No treatment control
| Arm | Type | Receives |
|---|---|---|
| Co-developed referral scheme | Experimental | Behavioral: Physical activity referral schemeA physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility. |
| Usual care referral scheme | Active comparator | Behavioral: Usual care exercise referral schemeComparative, usual care exercise referral scheme. |
| No treatment control | No intervention | –Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity referral schemeAn 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. | Behavioural | Co-developed referral scheme |
| Usual care exercise referral schemeA 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. | Behavioural | Usual care referral scheme |
Primary outcome
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.
17 secondary outcomes
Change in objective physical activity levels
Time frame: Baseline, week 12, and 6 months
Change in flow-mediated dilation
Time frame: Baseline and week 12.
Change in carotid vasoreactivity
Time frame: Baseline and week 12.
Change in total cholesterol
Time frame: Baseline and week 12.
Change in plasma glucose
Time frame: Baseline and week 12.
Change in triglycerides
Time frame: Baseline and week 12.
Change in self-reported physical activity
Time frame: Baseline, week 12, and 6 months.
Change in psychological wellbeing
Time frame: Baseline, week 12, and 6 months.
Attendance at consultations
Time frame: Week 1, 4, 8, 12, and 18
Attendance at fitness centre
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. Months 4, 5 and 6
Fidelity - consultation attendance
Time frame: Week 18
Fidelity - consultation communication strategies
Time frame: Week 1, 4, 8, 12, and 18
Change in health-related quality of life measure
Time frame: Baseline, week 12, and 6 months.
Intervention operating and set up costs
Time frame: Week 18
Loss in revenue costs
Time frame: Week 18
Change in patient costs
Time frame: Baseline, Week 12 and 6 months
Change in patient health care utilisation costs
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 33004383Buckley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula M Watson, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity referral scheme in people with Cardiovascular Risk Factor and Diabetes Mellitus, Type 2, run by Paula Watson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness (time frame: Baseline and week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.