Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts (STRENGTH)
Primary Purpose
Coronary Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self Management Strategies
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Disease focused on measuring Cardiac rehabilitation, Exercise, Secondary prevention
Eligibility Criteria
Inclusion Criteria: Participants referred to a maintenance stage cardiac rehabilitation programme Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Individuals in the control group will receive usual care
Outcomes
Primary Outcome Measures
Steps per Day in the last seven days
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
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Secondary Outcome Measures
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.
Physical and mental health
Measured using the self reported Short-form 12 (SF-12) Health Survey questionnaire
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.
Health-related quality of life
Measured using the self reported EuroQol-5D-3L questionnaire
Blood pressure
Resting systolic and diastolic blood pressure measured using a digital sphygmomanometer
Body mass index
Body mass divided by the square of height
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.
Full Information
NCT ID
NCT05705310
First Posted
January 6, 2023
Last Updated
January 26, 2023
Sponsor
University of Ulster
Collaborators
Belfast Health Development Unit, Belfast Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT05705310
Brief Title
Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
Acronym
STRENGTH
Official Title
The STRENGTH Study: Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Belfast Health Development Unit, Belfast Health and Social Care Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Cardiac rehabilitation, Exercise, Secondary prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
A separate researcher, not involved in the delivery of the intervention or assessment of outcomes, will generate the randomisation sequence which will be concealed in sealed opaque envelopes
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Individuals in the control group will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Self Management Strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Steps per Day in the last seven days
Description
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Time Frame
Change from baseline steps per day at 6 months
Title
Time spent in moderate-vigorous intensity physical activity in the last seven days
Description
Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days
Time Frame
Change from baseline time spent in moderate-vigorous intensity physical activity at 6 months
Secondary Outcome Measure Information:
Title
Physical activity self efficacy
Description
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.
Time Frame
Change from baseline physical activity self-efficacy at 6 months
Title
Physical and mental health
Description
Measured using the self reported Short-form 12 (SF-12) Health Survey questionnaire
Time Frame
Change from baseline physical and mental health at 6 months
Title
Mental wellbeing
Description
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.
Time Frame
Change from baseline mental wellbeing at 6 months
Title
Health-related quality of life
Description
Measured using the self reported EuroQol-5D-3L questionnaire
Time Frame
Change from baseline quality of life at 6 months
Title
Blood pressure
Description
Resting systolic and diastolic blood pressure measured using a digital sphygmomanometer
Time Frame
Change from baseline systolic and diastolic blood pressure at 6 months
Title
Body mass index
Description
Body mass divided by the square of height
Time Frame
Change from baseline body mass index at 6 months
Title
Waist and hip circumference
Description
Waist circumference will be measured as the midpoint between the lowest rib and the iliac crest, using a fibre glass tape.
Time Frame
Change from baseline waist and hip circumference at 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants referred to a maintenance stage cardiac rehabilitation programme
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole E Blackburn, PhD
Phone
02871675953
Email
ne.blackburn@ulster.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mark A Tully, PhD
Phone
02895367616
Email
m.tully@ulster.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole E Blackburn, PhD
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Learn more about this trial
Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
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