Coronary DiseaseSTRENGTHNCT05705310
Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
A study testing Self Management Strategies in people with Coronary Disease, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The goal of this intervention is translate current behaviour change in to community cardiac rehabilitation programmes for people living beyond a heart attack. The main question it aims to answer is whether adding a lifestyle change programme promoted maintenance of physical activity changes will be maintained… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Self Management Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 26 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants referred to a maintenance stage cardiac rehabilitation programme
Who cannot join
- Individuals who do not wish to provide consent to participate in this study or cannot commit to the full 12 weeks of the CR programme will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The STRENGTH Study: Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
The goal of this intervention is translate current behaviour change in to community cardiac rehabilitation programmes for people living beyond a heart attack. The main question it aims to answer is whether adding a lifestyle change programme promoted maintenance of physical activity changes will be maintained following a cardiac rehabilitation programme.
The problem Guidelines recommend that coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings. Cardiac rehabilitation programmes reduce the risk of death and illness, but it is likely that patients will stop exercising without enough support. New was to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed.
Read more
The project Behaviour change techniques can encourage patients to stay active for longer. The aim of this project is to see whether behaviour change can encourage coronary heart disease patients taking part in community-based cardiac rehabilitation programmes to stay active for longer compared with patients receiving the standard cardiac rehabilitation programme.
The benefits It is hoped that these methods will encourage more cardiac rehabilitation patients to stay physically active for longer and improve health. The results will provide more evidence on using behavioural change techniques in cardiac rehabilitation programmes and have the potential to benefit many patients with coronary heart disease throughout Northern Ireland and the rest of the United Kingdom.
Read the detailed description
Coronary heart disease is the leading cause of death and disability worldwide. Guidelines recommend that all coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings following a heart-related event, surgery or procedure.
The core cardiac rehabilitation programme (previously known as Phase III) is delivered by a clinical team in hospital. Depending on the location, it may involve a combination of exercise training, health education, and advice on reducing the risk of having a heart-related event such as ways to manage stress. After the patients complete this programme, participants are assessed for suitability to attend a community-based exercise programme called the maintenance cardiac rehabilitation programme (previously Phase IV). Cardiac rehabilitation programmes reduce the risk of death and illness, but evidence shows that it is unlikely that patients will maintain the required exercise levels without the support and structure provided by such exercise programmes. A previous study found that using behaviour change techniques, such as problem-solving skills, encouraged participants to stay active for longer. New ways to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed. The aim of this project is to translate behaviour change research in a cardiac rehabilitation programme to encourage coronary heart disease patients to stay active for longer.
The aim of this project is to translate behaviour change research into current maintenance stage (Phase IV) cardiac rehabilitation services. The hypothesis is that by adding a lifestyle change programme promoting self-efficacy, physical activity (PA) changes will be maintained following a cardiac rehabilitation programme.
All participants will be recruited while taking part in Active Belfast maintenance stage cardiac rehabilitation (CR) programmes. Participants will have already completed the Phase III core cardiac rehabilitation programme and been assessed for suitability to take part in the study. Some participants will be randomly chosen to receive the intervention which includes additional sessions to encourage active lifestyles. This will involve wearing a pedometer to count steps. Each week, participants will report their step counts and review their goals. In week eight, participants will have a group discussion with the researcher during which participants will discuss the benefits of physical activity. In week twelve, there will be a second group discussion about potential barriers to being active with advice on practical ways to do more activity. Participants will receive a monthly phone call from the exercise professional to check their progress and encourage them to adhere to the programme and achieve their weekly goals.
Participants in the control group will receive the standard cardiac rehabilitation maintenance programme. After the study, all participants will receive a pedometer and be given instructions on how to use it as well as a booklet from the Public Health Agency to advise them on how to increase their physical activity. Participants' physical activity will be measured using activity monitors at the beginning of the study, at twelve weeks (end of maintenance stage cardiac rehabilitation programme) and then at six months. Body measurements such as height, weight and blood pressure will also be taken, as well as a measure their physical and mental health. The difference in steps and time spent in moderate-vigorous physical activity between the intervention group and the control group after six months will be analysed. How well the intervention has been completed by participants (i.e. attendance records) and delivered by the exercise professional (i.e. satisfaction with the programme) will be assessed through interviews and focus groups. The cost-effective the study will also be evaluated.
- Conditions
- Coronary Disease
- Being tested
- Self Management Strategies
- Keywords
- Cardiac rehabilitation, Exercise, Secondary prevention
- Medical subject headings
- Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Management StrategiesBehavioural
During their maintenance stage cardiac rehabilitation programme, participants will be given a pedometer and asked to wear it during waking hours to record their daily step counts and/or time in physical activity each week. Participants will be encouraged to gradually achieve 150 minutes of moderate-intensity exercise per week and self-monitor their progress using the pedometer. At the end of every week, participants will review progress and set goals with an exercise professional. Group discussions will also take place, focusing on the benefits of regular physical activity, demonstrating lifestyle activities that can help accumulate activity and identifying various means of social support, and identifying local opportunities (groups or places) for physical activity after the cardiac rehabilitation programme has ended. Following this, they will receive a monthly phone call from the exercise professional to check progress and encourage them to continue with the programme.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Self Management Strategies |
| Control Group | No intervention | Individuals in the control group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per Day in the last seven days
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Measured: Change from baseline steps per day at 6 months
Time spent in moderate-vigorous intensity physical activity in the last seven days
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Measured: Change from baseline time spent in moderate-vigorous intensity physical activity at 6 months
Secondary outcomes (7)
Physical activity self efficacy
Physical activity self-efficacy scale. This scale includes nine items, each rated on a scale from 1 to 10. The minimum possible score is 9 and maximum score is 90, with higher scores indicating better self-efficacy.
Measured: Change from baseline physical activity self-efficacy at 6 months
Physical and mental health
Measured using the self reported Short-form 12 (SF-12) Health Survey questionnaire
Measured: Change from baseline physical and mental health at 6 months
Mental wellbeing
Measured using the self reported Warwick-Edinburgh Mental Well-being Scale (WEMWBS). This scale includes 14 items, each rated on a scale from 1 to 5. The minimum possible score is 14 and maximum score is 70, with higher scores indicating better metal wellbeing.
Measured: Change from baseline mental wellbeing at 6 months
Health-related quality of life
Measured using the self reported EuroQol-5D-3L questionnaire
Measured: Change from baseline quality of life at 6 months
Blood pressure
Resting systolic and diastolic blood pressure measured using a digital sphygmomanometer
Measured: Change from baseline systolic and diastolic blood pressure at 6 months
Body mass index
Body mass divided by the square of height
Measured: Change from baseline body mass index at 6 months
Waist and hip circumference
Waist circumference will be measured as the midpoint between the lowest rib and the iliac crest, using a fibre glass tape.
Measured: Change from baseline waist and hip circumference at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped-wedge cluster randomised controlled trial design will be employed involving random and sequential crossover of clusters from control to intervention until all clusters are exposed
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health Development Unit, Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Nicole E Blackburn, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705310
- Sponsor's protocol ID
- RG3_20-1-3.Z
- Acronym
- STRENGTH
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Doherty CTM, Tully MA, Wilson JJ, Irving V, Spratt L, O'Reilly R, Kensett K, Blackburn NE. Understanding participants' experiences of a behaviour change intervention within cardiac rehabilitation: A nested process evaluation within the STRENGTH randomised controlled trial. PLoS One. 2026 Jun 16;21(6):e0351117. doi: 10.1371/journal.pone.0351117. eCollection 2026.
PubMed 42302056Doherty CTM, Tully MA, Wilson JJ, Heron L, McAneney H, Irving V, Spratt L, O'Reilly R, Kensitt K, Blackburn NE. The STRENGTH Study: A cluster randomised controlled trial of the effect of a behaviour change intervention added to cardiac rehabilitation on physical activity adherence. PLoS One. 2026 Mar 24;21(3):e0345293. doi: 10.1371/journal.pone.0345293. eCollection 2026.
PubMed 41875187
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STRENGTH Study: Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
- ClinicalTrials.gov ID
- NCT05705310
- Acronym / sponsor ID
- STRENGTH / RG3_20-1-3.Z
- Conditions
- Coronary Disease
- Keywords
- Cardiac rehabilitation, Exercise, Secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health Development Unit, Belfast Health and Social Care Trust
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 30 Jan 2023 (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 goal of this intervention is translate current behaviour change in to community cardiac rehabilitation programmes for people living beyond a heart attack. The main question it aims to answer is whether adding a lifestyle change programme promoted maintenance of physical activity changes will be maintained following a cardiac rehabilitation programme.
The problem Guidelines recommend that coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings. Cardiac rehabilitation programmes reduce the risk of death and illness, but it is likely that patients will stop exercising without enough support. New was to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed.
The project Behaviour change techniques can encourage patients to stay active for longer. The aim of this project is to see whether behaviour change can encourage coronary heart disease patients taking part in community-based cardiac rehabilitation programmes to stay active for longer compared with patients receiving the standard cardiac rehabilitation programme.
The benefits It is hoped that these methods will encourage more cardiac rehabilitation patients to stay physically active for longer and improve health. The results will provide more evidence on using behavioural change techniques in cardiac rehabilitation programmes and have the potential to benefit many patients with coronary heart disease throughout Northern Ireland and the rest of the United Kingdom.
Detailed description
Coronary heart disease is the leading cause of death and disability worldwide. Guidelines recommend that all coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings following a heart-related event, surgery or procedure.
The core cardiac rehabilitation programme (previously known as Phase III) is delivered by a clinical team in hospital. Depending on the location, it may involve a combination of exercise training, health education, and advice on reducing the risk of having a heart-related event such as ways to manage stress. After the patients complete this programme, participants are assessed for suitability to attend a community-based exercise programme called the maintenance cardiac rehabilitation programme (previously Phase IV). Cardiac rehabilitation programmes reduce the risk of death and illness, but evidence shows that it is unlikely that patients will maintain the required exercise levels without the support and structure provided by such exercise programmes. A previous study found that using behaviour change techniques, such as problem-solving skills, encouraged participants to stay active for longer. New ways to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed. The aim of this project is to translate behaviour change research in a cardiac rehabilitation programme to encourage coronary heart disease patients to stay active for longer.
The aim of this project is to translate behaviour change research into current maintenance stage (Phase IV) cardiac rehabilitation services. The hypothesis is that by adding a lifestyle change programme promoting self-efficacy, physical activity (PA) changes will be maintained following a cardiac rehabilitation programme.
All participants will be recruited while taking part in Active Belfast maintenance stage cardiac rehabilitation (CR) programmes. Participants will have already completed the Phase III core cardiac rehabilitation programme and been assessed for suitability to take part in the study. Some participants will be randomly chosen to receive the intervention which includes additional sessions to encourage active lifestyles. This will involve wearing a pedometer to count steps. Each week, participants will report their step counts and review their goals. In week eight, participants will have a group discussion with the researcher during which participants will discuss the benefits of physical activity. In week twelve, there will be a second group discussion about potential barriers to being active with advice on practical ways to do more activity. Participants will receive a monthly phone call from the exercise professional to check their progress and encourage them to adhere to the programme and achieve their weekly goals.
Participants in the control group will receive the standard cardiac rehabilitation maintenance programme. After the study, all participants will receive a pedometer and be given instructions on how to use it as well as a booklet from the Public Health Agency to advise them on how to increase their physical activity. Participants' physical activity will be measured using activity monitors at the beginning of the study, at twelve weeks (end of maintenance stage cardiac rehabilitation programme) and then at six months. Body measurements such as height, weight and blood pressure will also be taken, as well as a measure their physical and mental health. The difference in steps and time spent in moderate-vigorous physical activity between the intervention group and the control group after six months will be analysed. How well the intervention has been completed by participants (i.e. attendance records) and delivered by the exercise professional (i.e. satisfaction with the programme) will be assessed through interviews and focus groups. The cost-effective the study will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A stepped-wedge cluster randomised controlled trial design will be employed involving random and sequential crossover of clusters from control to intervention until all clusters are exposed
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Self Management Strategies |
| Control Group | No intervention | –Individuals in the control group will receive usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants referred to a maintenance stage cardiac rehabilitation programme
Key exclusion criteria (1 listed)
- Individuals who do not wish to provide consent to participate in this study or cannot commit to the full 12 weeks of the CR programme will be excluded
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 |
|---|---|---|
| Self Management StrategiesDuring their maintenance stage cardiac rehabilitation programme, participants will be given a pedometer and asked to wear it during waking hours to record their daily step counts and/or time in physical activity each week. Participants will be encouraged to gradually achieve 150 minutes of moderate-intensity exercise per week and self-monitor their progress using the pedometer. At the end of every week, participants will review progress and set goals with an exercise professional. Group discussions will also take place, focusing on the benefits of regular physical activity, demonstrating lifestyle activities that can help accumulate activity and identifying various means of social support, and identifying local opportunities (groups or places) for physical activity after the cardiac rehabilitation programme has ended. Following this, they will receive a monthly phone call from the exercise professional to check progress and encourage them to continue with the programme. | Behavioural | Intervention Group |
Primary outcome
Steps per Day in the last seven days
Time frame: Change from baseline steps per day at 6 months
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Time spent in moderate-vigorous intensity physical activity in the last seven days
Time frame: Change from baseline time spent in moderate-vigorous intensity physical activity at 6 months
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
7 secondary outcomes
Physical activity self efficacy
Time frame: Change from baseline physical activity self-efficacy at 6 months
Physical and mental health
Time frame: Change from baseline physical and mental health at 6 months
Mental wellbeing
Time frame: Change from baseline mental wellbeing at 6 months
Health-related quality of life
Time frame: Change from baseline quality of life at 6 months
Blood pressure
Time frame: Change from baseline systolic and diastolic blood pressure at 6 months
Body mass index
Time frame: Change from baseline body mass index at 6 months
Waist and hip circumference
Time frame: Change from baseline waist and hip circumference at 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 9 Dec 2024.
- Derived from this study: PubMed 42302056Doherty CTM, Tully MA, Wilson JJ, Irving V, Spratt L, O'Reilly R, Kensett K, Blackburn NE. Understanding participants' experiences of a behaviour change intervention within cardiac rehabilitation: A nested process evaluation within the STRENGTH randomised controlled trial. PLoS One. 2026 Jun 16;21(6):e0351117. doi: 10.1371/journal.pone.0351117. eCollection 2026.
- Derived from this study: PubMed 41875187Doherty CTM, Tully MA, Wilson JJ, Heron L, McAneney H, Irving V, Spratt L, O'Reilly R, Kensitt K, Blackburn NE. The STRENGTH Study: A cluster randomised controlled trial of the effect of a behaviour change intervention added to cardiac rehabilitation on physical activity adherence. PLoS One. 2026 Mar 24;21(3):e0345293. doi: 10.1371/journal.pone.0345293. eCollection 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Nicole E Blackburn, PhD principal investigator
Ulster 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 Self Management Strategies in people with Coronary Disease, run by University of Ulster 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 1 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 9 Dec 2024. 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?
Steps per Day in the last seven days (time frame: Change from baseline steps per day at 6 months). The study lists 2 primary outcomes in all. 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 NCT05705310, which also lists 2 linked publications.
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 9 Dec 2024.