An interventional study of Standard Cardiac Rehabilitation Care and Tailored behavioural counselling in Cardiovascular Diseases (CVD), Coronary Disease and Heart Failure, sponsored by University of Lisbon. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Lisbon · Not applicable, Interventional, and Prevention
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.
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.
5,033 studies on the registry are indexed under Cardiovascular Diseases; 932 are open to participants now.
This study's planned enrollment of 64 is below the median of 100 across 2,806 interventional studies indexed under Cardiovascular Diseases.
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SCG will receive usual care consisting of 60-minute supervised CR exercise sessions, 2-3 times per week, delivered online or face-to-face according to preference. Each session includes a 5-10 minute warm-up, 30-45 minutes of aerobic training (40-69% HRR, 12-14 RPE) combined with resistance training (8-10 exercises, 40-80% 1-RM, 12-15 repetitions, 2 sets), and a 5-10 minute cool down. In addition, participants will attend one baseline consultation with an exercise physiologist to receive feedback on initial assessments and education on sedentary behaviour and physical activity aligned with WHO guidelines, and will have access to on-demand educational videos on SB and PA.
Behavioral: Standard Cardiac Rehabilitation Care
IG will receive the same as SCG plus a 6-month tailored behavioral intervention to reduce SB by increasing PA. The intervention includes six brief (10-15 min) individualized counselling sessions with an exercise physiologist, supported by the official Brief Counselling Tools for Physical Activity Promotion (Directorate-General of Health, Portugal, 2018). Participants also receive digital prompts (SMS, WhatsApp, or email according to preference), which are general in the first month and, after barriers/facilitators are identified, tailored using the COM-B model with appropriate Behavior Change Techniques. Prompts are delivered weekly in the intensive phase (0-3 months) and biweekly in the moderate phase (3-6 months). Educational videos are available to both SCG and IG.
Behavioral: Standard Cardiac Rehabilitation Care · Behavioral: Tailored behavioural counselling · Behavioral: Digital prompts
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.
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).
Also known as: Tailored counselling
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).
Change in daily sedentary time (h/day)
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.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in sedentary time (% of waking time)
Sedentary time as a percentage of waking wear 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. For each valid day, sedentary time (%) will be calculated as minutes classified as sitting/lying during waking wear time divided by total minutes of waking wear time, multiplied by 100. 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 of the daily percentages across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily number of breaks in sedentary time (breaks/day)
The daily number of breaks in sedentary time will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A break will be defined as a transition from sitting/lying to standing or stepping during waking wear time. 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 number of breaks across valid days, expressed as breaks/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily number of sedentary bouts (bouts/day)
The daily number of sedentary bouts will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. The outcome will be the mean number of sedentary bouts per day across valid days, expressed as bouts/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in median sedentary bout duration (min)
Median sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the median duration of sedentary bouts will be calculated in minutes. The outcome will be the mean of these daily medians across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in mean sedentary bout duration (min)
Mean sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, mean sedentary bout duration will be calculated by dividing total sedentary time by the number of sedentary bouts, expressed in minutes. The outcome will be the average of these daily means across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in maximum sedentary bout duration (min)
Maximum sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the duration of the longest sedentary bout will be identified in minutes. The outcome will be the mean of these daily maximum durations across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily time accumulated in sedentary bouts lasting ≥30 minutes (min/day)
Daily time accumulated in sedentary bouts lasting at least 30 minutes will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the full duration of all sedentary bouts lasting at least 30 minutes will be summed. The outcome will be the mean of these daily totals across valid days, expressed as minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily time accumulated in sedentary bouts lasting ≥60 minutes (min/day)
Daily time accumulated in sedentary bouts lasting at least 60 minutes will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking wear time. For each valid day, the full duration of all sedentary bouts lasting at least 60 minutes will be summed. The outcome will be the mean of these daily totals across valid days, expressed as minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily light-intensity physical activity (min/day)
Light-intensity physical activity will be assessed using an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-hour wear protocol. Raw signals will be processed using GGIR in R to derive Euclidean Norm Minus One (ENMO). Light-intensity physical activity will be defined as time with ENMO values from 45 to less than 100 mg. The outcome will be the mean daily time spent in light-intensity physical activity across valid days, expressed in minutes/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 main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change in daily moderate-to-vigorous physical activity (min/day)
Moderate-to-vigorous physical activity (MVPA) will be assessed using an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-hour wear protocol. Raw signals will be processed using GGIR in R to derive Euclidean Norm Minus One (ENMO). MVPA will be defined as time with ENMO values of at least 100 mg. The outcome will be the mean daily time spent in MVPA across valid days, expressed in minutes/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 main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in steps per day (count/day)
PA will be assessed with an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-h wear protocol. Steps per day will be obtained from the device's step algorithm and averaged across valid days. A valid day requires ≥10 h of waking wear time; a valid week requires ≥4 valid days (including ≥1 weekend day). The main comparison is change from baseline to 6 months; additional time points at 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Change in total body fat mass (kg)
Total body fat mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in total body fat percentage (%)
Total body fat percentage will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed as the percentage of total body mass that is fat mass. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in total body lean mass (kg)
Total body lean mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed in kilograms. Lean mass refers to lean soft tissue, excluding fat mass and bone mineral content. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in appendicular lean mass (kg)
Appendicular lean mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and calculated as the sum of lean soft tissue mass in both arms and both legs, excluding bone mineral content. The outcome will be expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months.
Change in estimated visceral adipose tissue mass (g)
Visceral adipose tissue mass will be estimated from whole-body dual-energy X-ray absorptiometry (DXA) scans using the Hologic system's visceral fat analysis software. The software estimates visceral adipose tissue within an abdominal region of interest by subtracting estimated subcutaneous fat from total fat in that region. The outcome will be expressed in grams. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months.
Change in whole-body bone mineral density (g/cm²)
Whole-body areal bone mineral density will be assessed using dual-energy X-ray absorptiometry (DXA) and expressed in grams per square centimetre (g/cm²). Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months.
Change in peak oxygen uptake (VO₂peak; mL/kg/min)
Peak oxygen uptake (VO₂peak) will be assessed using a symptom-limited incremental cardiopulmonary exercise test (CPET) performed on a cycle ergometer with breath-by-breath gas analysis. VO₂peak will be defined as the highest 30-second average oxygen uptake recorded during the final minute of exercise and expressed in millilitres of oxygen per kilogram of body mass per minute (mL/kg/min). Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in peak workload (W)
Peak workload will be assessed using a symptom-limited incremental cardiopulmonary exercise test (CPET) performed on a cycle ergometer. Peak workload will be defined as the highest work rate reached during the exercise phase and expressed in watts (W). Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months.
Change in handgrip strength (kg)
Handgrip strength will be assessed using a digital hand dynamometer. Three attempts will be performed with each hand, and the highest value obtained for each hand will be selected. The outcome will be calculated as the mean of the highest left-hand and right-hand values and expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in health-related quality of life assessed by the SF-36
Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The questionnaire assesses eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes will be assessed from baseline to 3 months and from baseline to 12 months.
Time frame: Baseline, 3 months, 12 months
Change in self-reported daily sedentary time (min/day)
Self-reported sedentary time will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report the time spent sitting, reclining, or lying down while awake on a typical weekday/workday and weekend/non-workday. Responses will be converted to minutes per day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months and 12 months
Change in self-reported daily light-intensity physical activity (min/day)
Self-reported light-intensity physical activity will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report their daily time spent in light-intensity aerobic and muscle-strengthening activities during a typical week, distinguishing weekday/workdays from weekend/non-workdays. Times will be converted to minutes and summed to obtain total light-intensity physical activity. Mean daily time will be calculated by weighting each day type by its frequency in the week. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in self-reported daily moderate-to-vigorous physical activity (min/day)
Self-reported moderate-to-vigorous physical activity will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report time spent in moderate- and vigorous-intensity aerobic and muscle-strengthening activities for each day of a typical week. Times will be converted to minutes and summed across activity types, intensities, and all seven days. The weekly total will be divided by seven to obtain mean daily moderate-to-vigorous physical activity, expressed in minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months.
Attendance at behavioural counselling sessions (%)
Attendance at behavioural counselling sessions will be assessed in participants allocated to the intervention group. For each participant, attendance will be calculated as the number of counselling sessions attended divided by the number of counselling sessions scheduled during the 6-month intervention period, multiplied by 100. Attendance will be documented in study records.
Time frame: During the intervention period (0-6 months).
Attendance at supervised cardiac rehabilitation exercise sessions (%)
Attendance at supervised cardiac rehabilitation exercise sessions will be assessed in both study groups. For each participant, attendance will be calculated as the number of exercise sessions attended divided by the number of scheduled exercise sessions during the 12-month study period, multiplied by 100. Attendance will be obtained from the cardiac rehabilitation programme's attendance records.
Time frame: During the 12-month study period (0-12 months).
Delivery of scheduled digital prompts (%)
Delivery of digital prompts will be assessed in participants allocated to the intervention group. For each participant, the delivery percentage will be calculated as the number of digital prompts sent divided by the number of digital prompts scheduled during the 6-month intervention period, multiplied by 100. Sending of prompts will be documented in study records. This measure assesses intervention delivery rather than whether participants read or acted on the prompts.
Time frame: During the intervention period (0-6 months).
Change in activPAL-estimated time in bed (hours/night; exploratory)
Time in bed will be estimated using activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm to identify the main nightly time-in-bed period. Algorithm-defined periods will be visually reviewed. A valid night will require a complete recording covering this period, without device removal or data loss preventing identification of its start and end. At least 4 valid nights, including at least 1 weekend night, will be required. The outcome will be the mean estimated time in bed across valid nights, expressed in hours/night. This measure represents estimated time in bed rather than actual sleep duration. Changes will be assessed from baseline to 3, 6, and 12 months.
Time frame: Baseline, 3, 6, and 12 months.
Discrepancy between self-reported and device-measured sedentary time (min/day; exploratory)
Discrepancy in daily sedentary time will be calculated as self-reported sedentary time assessed using the QMov24h questionnaire minus sedentary time estimated using activPAL4 micro, both expressed in minutes/day. Negative values indicate lower self-reported estimates than device-measured estimates, whereas positive values indicate higher self-reported estimates. Differences will be calculated at each assessment, and changes from baseline to 3, 6, and 12 months will be explored. Interpretation will account for the different reference periods: a typical week for the questionnaire and the monitored days for activPAL.
Time frame: Baseline, 3 months, 6 months, and 12 months
Plan to share: Undecided — The plan for sharing de-identified individual participant data has not yet been determined. Any future decision regarding data sharing will take into account participant consent, ethical approvals, and applicable data protection requirements. The registry record will be updated when a decision has been made.
Started Oct 2025 (actual). Primary completion is estimated for Aug 2027, 22 months after the start.
Of 1,038 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 22 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 26 months; a quarter within 12 and three quarters within 48.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Lisbon