NCT03490747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

January 11, 2018

Last Update Submit

September 27, 2019

Conditions

Cardiovascular Risk FactorDiabetes Mellitus, Type 2AnxietyDepressionMusculoskeletal InjuryCardiovascular DiseasesCancerObesityMetabolic SyndromePhysical Activity

Keywords

Physical ActivityPragmatic EvaluationExercise ReferralMixed-methodsBehaviour ChangeIntervention

Outcome Measures

Primary Outcomes (1)

  • Change in cardiorespiratory fitness

    Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.

    Baseline and week 12.

Secondary Outcomes (17)

  • Change in objective physical activity levels

    Baseline, week 12, and 6 months

  • Change in flow-mediated dilation

    Baseline and week 12.

  • Change in carotid vasoreactivity

    Baseline and week 12.

  • Change in total cholesterol

    Baseline and week 12.

  • Change in plasma glucose

    Baseline and week 12.

  • +12 more secondary outcomes

Other Outcomes (7)

  • Change in exercise motivation

    Baseline, week 12, and 6 months.

  • Change in psychological needs satisfaction

    Baseline, week 12, and 6 months.

  • Change in perceived needs support

    Baseline, week 12, and 6 months.

  • +4 more other outcomes

Study Arms (3)

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.

Behavioral: Physical activity referral scheme

Usual care referral scheme

ACTIVE COMPARATOR

Comparative, usual care exercise referral scheme.

Behavioral: Usual care exercise referral scheme

No treatment control

NO INTERVENTION

Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments).

Interventions

Physical activity referral schemeBEHAVIORAL

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.

Co-developed referral scheme
Usual care exercise referral schemeBEHAVIORAL

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.

Usual care referral scheme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 2AT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33004383DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Anxiety DisordersDepressionCardiovascular DiseasesNeoplasmsObesityMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental DisordersBehavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinism

Study Officials

  • Paula M Watson, PhD

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Post hoc data analysis will be blinded via an independent coding method for condition and time frame (i.e. pre-post measures).
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 3 arm quasi-experimental trial 1\. Co-developed scheme 2. Usual care 3. No treatment control
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

January 11, 2018

First Posted

April 6, 2018

Study Start

March 12, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)