Movement as medicine for cardiovascular disease prevention
| ISRCTN | ISRCTN14582348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14582348 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/08/2012
- Registration date
- 03/10/2012
- Last edited
- 30/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims:
Research has demonstrated that physical activity has a clear protective effect on cardiovascular disease (CVD). What is not well understood is how best to support people who are at increased risk of cardiovascular disease to become more physically active and maintain this over time. This study aims to find out whether the use of structured support provided by healthcare professionals in primary care is feasible, acceptable and effective for increasing levels of physical activity in patients with increased risk of CVD.
Who can participate?
All primary care organisations within County Durham and Darlington will be invited to take part in the study. Patients aged 18 years or over who have been identified as at increased risk of cardiovascular disease or as 'inactive' or 'moderately inactive' in a recent NHS Health Check.
What does the study involve?
All primary care organisations in the County Durham and Darlington region are invited to take part in the study. Healthcare professionals are given access to the online intervention which comprises 11 distinct yet inter-related modules on topics such as physical activity and sedentary behaviour in relation to CVD, and the processes involved in behaviour change. The course aims to equip healthcare professionals working in primary care with knowledge and skills to deliver a behavioural intervention designed to increase levels of physical activity of their patients. Patients have three conversations (one face-to-face and two via telephone) of up to 30 minutes each with their healthcare professional at the start of the study (baseline), and after 2 and 4 months. They are also provided with access to an online behaviour change 'toolkit'. This website provides them with information on physical activity, but also tools for them to set physical activity goals, plans and monitor their progress.
What are the possible benefits and risks of participating?
The time taken for the healthcare professionals to complete the online intervention, the survey questionnaires and participate in interviews as well as delivering the intervention could be considered burdensome. However, the knowledge and skills potentially gained following successful completion of the intervention are considered to outweigh the burden of taking part. Additionally, professionals receive CPD credit for completing the intervention. The time taken for the patients to have additional consultations with their healthcare professional, complete paper-based survey questionnaires and wear an accelerometer for 7 days during each data collection time point (baseline, 3 and 6 months) may be considered burdensome. However, the potential benefits the patients may experience if they increase their physical activity are anticipated to outweigh the burden of taking part and any inconvenience encountered.
Where is the study run from?
The study is run by Newcastle University; however, it will be carried out in primary care organisations across the County Durham and Darlington region.
When is the study starting and how long is it expected to run for?
June 2014 to June 2015
Who is funding the study?
County Durham Sport
Who is the main contact?
Dr Mike Trenell
michael.trenell@ncl.ac.uk
Contact information
Scientific
Newcastle University
Faculty of Medical Sciences
William Leech Building
Institute of Cellular Medicine
Newcastle Upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 6935 |
|---|---|
| michael.trenell@ncl.ac.uk |
Study information
| Study design | One-group exploratory trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Feasibility, acceptability and effectiveness of a multi-faceted behavioural intervention targeting levels of physical activity in adults at increased risk of cardiovascular disease in primary care: movement as medicine for cardiovascular disease prevention |
| Study objectives | A theory-based behavioural intervention will be more effective than standard clinical care for impacting positively on levels of free living physical activity on risks of developing cardiovascular disease. |
| Ethics approval(s) | NRES Committee North East - Newcastle & North Tyneside 1, 25/03/2014, 14/NE/0062 |
| Health condition(s) or problem(s) studied | Increased risk of cardiovascular disease |
| Intervention | Current interventions as of 27/05/2014: A theory-based accredited online training programme for primary care practitioners. An online toolkit consisting of physical activity promotion materials, activity planners and trackers and a pedometer for patients. Patients will have three conversations (one face-to-face and two via telephone) of up to 30 minutes each with their healthcare professional at baseline, 2 and 4 months. Previous interventions: A theory-based accredited online training programme for primary care practitioners and a toolkit physical activity promotion materials, activity planners and trackers and a pedometer. Intervention group: Patients will attend face to face review appointments over a 12-month period (baseline, 1, 6 and 12 months) where they will be supported using the toolkit to increase their levels of physical activity. Control group: Standard clinical care. Both the intervention and control group will receive a telephone call at 3 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 27/05/2014: Primary care practitioners: Use of behaviour change techniques and counselling skills Patients: Engagement in the programme Previous primary outcome measures: Primary care practitioners: Use of behaviour change techniques and counselling skills Patients: Objectively and subjectively assessed physical activity behaviour |
| Secondary outcome measures | Current secondary outcome measures as of 27/05/2014: Primary care practitioners: 1. Cardiovascular disease and physical activity-related knowledge and attitudes/beliefs 2. Self-efficacy for delivering physical activity-related counselling to adults at increased cardiovascular disease risk 3. Use of online course materials Patients: 1. Theoretical predictors of physical activity 2. Sedentary behaviour patterns 3. Use and evaluation of intervention materials Previous secondary outcome measures: Primary care practitioners: 1. Cardiovascular disease and physical activity-related knowledge and attitudes/beliefs 2. Self efficacy for delivering physical activity-related counseling to adults at increased cardiovascular disease risk Patients: 1. Cholesterol 2. Blood pressure 3. Body mass index (BMI) and waist circumference 4. Cardiovascular disease and physical activity related knowledge and attitudes / beliefs 5. Physical activity related self efficacy 6. Health-related quality of life 7. Sedentary behaviour patterns 8. Achievement of physical activity goals |
| Overall study start date | 01/06/2014 |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 83 |
| Key inclusion criteria | Current inclusion criteria as of 27/05/2014: 1. Age between 18-75 years 2. Have the capacity to provide informed written consent 3. Able to read, speak and understand English without the support of an interpreter 4. Have access to the internet and therefore all intervention materials 5. Deemed fit to partake in physical activity/exercise by the Physical Activity Readiness Questionnaire (PAR-Q) 6. Have been identified as physically inactive with the General Practice Physical Activity Questionnaire (GPPAQ) during an NHS Health Check OR identified as having at least a 20% risk of CVD in the next 10 years Previous inclusion criteria: 1. Adults aged ≥18 years 2. Identified to be at increased cardiovascular disease risk 3. Physical activity/ exercise is below recommendations (i.e. 30 minutes per day three times per week) 4. Capacity to provide informed consent 5. Ability to write and converse in English |
| Key exclusion criteria | Contra-indications to performing physical activity |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 01/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4HH
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Susan Ridge
Newcastle Joint Research Office (Research & Development)
Level 6
Leazes Wing
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Phone | + 44 (0)191 282 4823 |
|---|---|
| susan.ridge@nuth.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/06/2022 | 30/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/06/2022: Publication reference and total final enrolment added.
13/08/2020: No publications found.
18/09/2017: No publications found, verifying study status with principal investigator.
27/05/2014: The following changes were made to the trial record:
1. The study design was changed from 'Single centre clustered randomised controlled with parallel groups' to 'One-group exploratory trial'.
2. The target number of participants was changed from 400 to 200.
3. The overall trial start date was changed from 31/01/2013 to 01/06/2014.
4. The overall trial end date was changed from 30/01/2015 to 01/06/2015.
The previous sponsor for this trial (up to 27/05/2014) was:
NHS County Durham and Darlington (UK)
c/o Richard Errington
John Snow House
Durham University Science Park
County Durham
DH1 3YG
United Kingdom
+44 (0)191 374 4211
richard.errington@nhs.net
http://www.countydurham.nhs.uk/
