Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Cardiac Rehabilitation Care: Participants will receive usual care consisting of 60 minutes CR exercise sessions 2 or 3 times/week either online or in a face-to-face model (according to preference). Each exercise session starts with a 5'-10' minutes warm-up, followed by a 30'-45' minutes of combined training with an aerobic component - moderate intensity (40% to 69% of Heart Rate Reserve (HRR); 12-14 RPE) and a strength component - 8 to 10 exercises, 40-80% of 1-RM, 12-15 repetitions, 2 sets - ending with a 5'-10' minute cool down. Participants will have an individual consultation with an exercise physiologist to receive feedback over baseline assessments and SB/PA education (WHO guidelines) and will have access to educational videos on SB and PA that can be consulted at any time.

Tailored behavioural counselling: Participants in the IG will receive six brief (10-15 min) individualized counselling sessions with an exercise physiologist at baseline, 1, 2, 3, 6, and 12 months. Sessions include feedback on assessments, education on WHO PA/SB guidelines, identification of barriers and facilitators, shared decision-making, goal setting and review, reinforcement of strategies, and maintenance planning. Counselling is supported by the official Brief Counselling Tools for Physical Activity Promotion (Directorate-General of Health, Portugal, 2018), including the Physical Activity Guide, Decision Aid, Action Plan, and Maintenance Plan. Participants are encouraged to use a smartphone application to self-monitor daily step count throughout the intervention. Self-monitoring supports behavioural strategies during the intensive (0-3 months) and moderate (3-6 months) phases, followed by a no-contact follow-up (6-12 months).

Digital prompts: Participants in the IG will receive digital prompts throughout the intervention, delivered via SMS, WhatsApp, or email according to preference. During the first month, prompts are general, focusing on awareness, motivation, and reinforcement of PA/SB recommendations. After barriers and facilitators are identified in counselling sessions, prompts are tailored using the COM-B model, with Behavior Change Techniques such as goal setting, self-reward, social support, information on consequences, or restructuring barriers applied according to whether the challenge relates to Capability, Opportunity, or Motivation. Prompts are written to be concise, practical, and easy to integrate into daily routines. They are delivered weekly during the intensive phase (0-3 months) and biweekly during the moderate phase (3-6 months). No prompts are delivered during the follow-up phase (6-12 months).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in daily sedentary time (h/day) — Baseline, 3 months, 6 months, 12 months
  Daily sedentary time will be measured using activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days per assessment under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm to identify time in bed and non-wear periods. Sedentary time will be calculated as time classified as sitting/lying during waking wear time, expressed in hours/day. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The outcome will be the mean daily sedentary time across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.

Trial sites (1)

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