Overview
Sedentary behaviour (SB) is an independent cardiovascular risk factor that remains highly prevalent among individuals attending long-term cardiac rehabilitation (CR) programs, despite participation in regular supervised exercise. Although CR provides an ideal setting for promoting healthy lifestyle behaviours, evidence on tailored interventions specifically targeting SB in long-term CR programs remains limited.
This randomized controlled trial aims to evaluate the effectiveness of a 6-month tailored behavioural intervention, supported by digital health tools, in reducing SB among adults attending a long-term phase CR program. Participants will be randomly allocated to either an intervention group (IG), receiving standard CR plus individualized behavioural counselling, digital prompts, and educational resources, or a standard care group (SCG) receiving usual CR and educational resources only.
The primary outcome is objectively measured daily sedentary time assessed using activPAL4 (h/day). Secondary outcomes include objectively measured physical activity (PA), body composition, cardiorespiratory fitness, muscular strength, health-related quality of life and other behavioural outcomes. Outcomes will be assessed at baseline, 3, 6, and 12 months, according to the specific assessment schedule. The study aims to determine whether integrating a tailored behavioural intervention into routine long-term CR leads to sustained improvements in SB and related health outcomes.
Description
Cardiovascular disease (CVD) remains one of the leading causes of morbidity and mortality worldwide despite substantial advances in medical treatment and CR. Although participation in CR improves cardiovascular health and increases PA levels, many participants continue to spend a large proportion of their waking hours in SB. Growing evidence suggests that SB represents an independent health risk that should be addressed in addition to promoting regular PA.
Long-term CR provides a unique opportunity to support sustainable lifestyle changes. At this stage, participants have generally completed the more intensive phases of rehabilitation and transition towards long-term self-management, making behaviour change strategies particularly relevant. However, interventions specifically designed to reduce SB within long-term CR remain limited, and evidence regarding their long-term effectiveness is still scarce.
This study was designed to evaluate whether integrating a tailored behavioural intervention into routine long-term CR can produce sustained reductions in SB while supporting broader improvements in health-related outcomes. The intervention combines individualized behavioural counselling, digital health tools, including smartphone-based self-monitoring, tailored digital prompts, educational resources, and ongoing behavioural reinforcement to facilitate the adoption and maintenance of healthier behaviours.
The intervention was developed using an evidence-informed approach grounded in behaviour change theory. During counselling sessions, individual barriers and facilitators are identified and mapped onto the Capability, Opportunity, Motivation-Behaviour (COM-B) model. This process guides the selection of appropriate Behaviour Change Techniques (BCTs), which are used to tailor the digital prompts to each participant's behavioural needs. Educational materials were developed through a patient and public involvement (PPI) process to maximise their relevance, acceptability, and integration into routine clinical practice.
By evaluating a theory-informed, tailored behavioural intervention integrated into routine long-term CR, this trial aims to generate evidence on effective strategies for reducing SB in people living with CVD. The findings may contribute to the development of more personalized and sustainable approaches to behaviour change and support the integration of SB reduction into long-term CR practice.
Eligibility
Inclusion Criteria:
- Adults aged 18 years or older
- Clinically stable
- Documented cardiovascular disease (CVD), including angiographically documented coronary artery disease involving at least one major epicardial vessel, previous myocardial infarction, previous coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), heart failure (including cardiac transplantation), heart valve surgery or prosthetic valve/clip implantation, left ventricular assist devices, cardiac resynchronization therapy devices, implantable cardioverter-defibrillators, pacemakers, or congenital heart disease
- Enrolled in a long-term (phase III) cardiac rehabilitation (CR) programme for at least 6 months
- More than 8 hours per day of sedentary behaviour (SB), objectively assessed using activPAL4 during the baseline assessment
Exclusion Criteria:
- Unable or unwilling to provide written informed consent
- Do not own a smartphone compatible with the study digital health tools
