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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
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring Cardiac rehabilitation, Exercise, Secondary prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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