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

NCT05705310 | Completed

• 1 other identifier: RG3_20-1-3.Z
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

Cardiac rehabilitation; Exercise; Secondary prevention

Outcome Measures

Primary Outcomes (2)

• Steps per Day in the last seven days

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

  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

  Change from baseline time spent in moderate-vigorous intensity physical activity at 6 months

Secondary Outcomes (7)

• Physical activity self efficacy

  Change from baseline physical activity self-efficacy at 6 months

• Physical and mental health

  Change from baseline physical and mental health at 6 months

• Mental wellbeing

  Change from baseline mental wellbeing at 6 months

• Health-related quality of life

  Change from baseline quality of life at 6 months

• Blood pressure

  Change from baseline systolic and diastolic blood pressure at 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Self Management Strategies

Control Group

NO INTERVENTION

Individuals in the control group will receive usual care

Interventions

Self Management Strategies BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants referred to a maintenance stage cardiac rehabilitation programme

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ulster University

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Study Officials

• Nicole E Blackburn, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 30, 2023
• Study Start: March 1, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)