STRENGTH: Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts

Sponsor
University of Ulster (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05705310
Collaborator
Belfast Health Development Unit (Other), Belfast Health and Social Care Trust (Other)
100
2
29

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self Management Strategies
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 exposedA 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 (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
Primary Purpose:
Prevention
Official Title:
The STRENGTH Study: Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Behavioral: Self Management Strategies
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.

No Intervention: Control Group

Individuals in the control group will receive usual care

Outcome Measures

Primary Outcome Measures

  1. Steps per Day in the last seven days [Change from baseline steps per day at 6 months]

    Measured using a validated ActiGraph GT3X+ accelerometer worn for 7 consecutive days

  2. Time spent in moderate-vigorous intensity physical activity in the last seven days [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

Secondary Outcome Measures

  1. Physical activity self efficacy [Change from baseline physical activity self-efficacy at 6 months]

    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.

  2. Physical and mental health [Change from baseline physical and mental health at 6 months]

    Measured using the self reported Short-form 12 (SF-12) Health Survey questionnaire

  3. Mental wellbeing [Change from baseline mental wellbeing at 6 months]

    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.

  4. Health-related quality of life [Change from baseline quality of life at 6 months]

    Measured using the self reported EuroQol-5D-3L questionnaire

  5. Blood pressure [Change from baseline systolic and diastolic blood pressure at 6 months]

    Resting systolic and diastolic blood pressure measured using a digital sphygmomanometer

  6. Body mass index [Change from baseline body mass index at 6 months]

    Body mass divided by the square of height

  7. Waist and hip circumference [Change from baseline waist and hip circumference at 6 months]

    Waist circumference will be measured as the midpoint between the lowest rib and the iliac crest, using a fibre glass tape.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Ulster
  • Belfast Health Development Unit
  • Belfast Health and Social Care Trust

Investigators

  • Principal Investigator: Nicole E Blackburn, PhD, Ulster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Ulster
ClinicalTrials.gov Identifier:
NCT05705310
Other Study ID Numbers:
  • RG3_20-1-3.Z
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Ulster
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023