Cardiovascular Diseases (CVD)REDUsitNCT07910812
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
A study testing Standard Cardiac Rehabilitation Care, Tailored behavioural counselling and Digital prompts in people with Cardiovascular Diseases (CVD) and Coronary Disease, run by University of Lisbon at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases (CVD), Coronary Disease, Heart Failure
- What is being tested?
- Standard Cardiac Rehabilitation Care, Tailored behavioural counselling and Digital prompts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide written informed consent
- Do not own a smartphone compatible with the study digital health tools
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine of the University of Lisbon
Lisbon, Lisbon District, 1649-028
Mariana Durão Borges, PhD Student, +351912328080, marianaborges1@edu.ulisboa.pt
About this study
Official title: Effects of a Tailored Intervention With Digital Health Tools on Sedentary Behaviour and Health-related Physical Outcomes in Long-term Cardiac Rehabilitation Patients: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases (CVD), Coronary Disease, Heart Failure, Cardiac Rehabilitation, Sedentary Behaviour
- Being tested
- Standard Cardiac Rehabilitation Care, Tailored behavioural counselling, Digital prompts
- Keywords
- Sedentary Behaviour, Physical Activity, Digital Health, Cardiac Rehabilitation, Tailored counselling, Behaviour change
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Cardiac Rehabilitation CareBehavioural
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 counsellingBehavioural
Also called Tailored 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 promptsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard Care Group | Active comparator | 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. Receives: Behavioral: Standard Cardiac Rehabilitation Care |
| Intervention Group | Experimental | 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. Receives: Behavioral: Standard Cardiac Rehabilitation Care; Behavioral: Tailored behavioural counselling; Behavioral: Digital prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the intervention period (0-6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Oct 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, two-arm, parallel-group RCT within a long-term (phase III) cardiac rehabilitation program; 1:1 allocation; assessments at baseline, 3, 6 and 12 months
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Durão Borges, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910812
- Sponsor's protocol ID
- 2023.01134.BD
- Other IDs
- 2023
- Acronym
- REDUsit
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
PubMed 23512568Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Dempsey PC, Matthews CE, Dashti SG, Doherty AR, Bergouignan A, van Roekel EH, Dunstan DW, Wareham NJ, Yates TE, Wijndaele K, Lynch BM. Sedentary Behavior and Chronic Disease: Mechanisms and Future Directions. J Phys Act Health. 2020 Jan 1;17(1):52-61. doi: 10.1123/jpah.2019-0377.
PubMed 31794961Dunstan DW, Dogra S, Carter SE, Owen N. Sit less and move more for cardiovascular health: emerging insights and opportunities. Nat Rev Cardiol. 2021 Sep;18(9):637-648. doi: 10.1038/s41569-021-00547-y. Epub 2021 May 20.
PubMed 34017139Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
PubMed 33611446
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Tailored Intervention With Digital Health Tools on Sedentary Behaviour and Health-related Physical Outcomes in Long-term Cardiac Rehabilitation Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07910812
- Acronym / sponsor ID
- REDUsit / 2023.01134.BD
- Conditions
- Cardiovascular Diseases (CVD), Coronary Disease, Heart Failure, Cardiac Rehabilitation, Sedentary Behaviour
- Keywords
- Sedentary Behaviour, Physical Activity, Digital Health, Cardiac Rehabilitation, Tailored counselling, Behaviour change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, two-arm, parallel-group RCT within a long-term (phase III) cardiac rehabilitation program; 1:1 allocation; assessments at baseline, 3, 6 and 12 months
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Behavioral: Standard Cardiac Rehabilitation CareSCG 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. |
| Intervention Group | Experimental | Behavioral: Standard Cardiac Rehabilitation Care, Behavioral: Tailored behavioural counselling, Behavioral: Digital promptsIG 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable or unwilling to provide written informed consent
- Do not own a smartphone compatible with the study digital health tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Cardiac Rehabilitation CareParticipants 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. | Behavioural | Intervention Group, Standard Care Group |
| Tailored behavioural counsellingAlso: Tailored counsellingParticipants 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). | Behavioural | Intervention Group |
| Digital promptsParticipants 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). | Behavioural | Intervention Group |
Primary outcome
Change in daily sedentary time (h/day)
Time frame: 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.
27 secondary outcomes
Change in sedentary time (% of waking time)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily number of breaks in sedentary time (breaks/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily number of sedentary bouts (bouts/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in median sedentary bout duration (min)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in mean sedentary bout duration (min)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in maximum sedentary bout duration (min)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily time accumulated in sedentary bouts lasting ≥30 minutes (min/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily time accumulated in sedentary bouts lasting ≥60 minutes (min/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in daily light-intensity physical activity (min/day)
Time frame: Baseline, 3 months, 6 months, and 12 months
Change in daily moderate-to-vigorous physical activity (min/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in steps per day (count/day)
Time frame: Baseline, 3 months, 6 months, and 12 months.
Change in total body fat mass (kg)
Time frame: Baseline, 3 months, 12 months
Change in total body fat percentage (%)
Time frame: Baseline, 3 months, 12 months
Change in total body lean mass (kg)
Time frame: Baseline, 3 months, 12 months
Change in appendicular lean mass (kg)
Time frame: Baseline, 3 months, 12 months.
Change in estimated visceral adipose tissue mass (g)
Time frame: Baseline, 3 months, 12 months.
Change in whole-body bone mineral density (g/cm²)
Time frame: Baseline, 3 months, 12 months.
Change in peak oxygen uptake (VO₂peak; mL/kg/min)
Time frame: Baseline, 3 months, 12 months
Change in peak workload (W)
Time frame: Baseline, 3 months, 12 months.
Change in handgrip strength (kg)
Time frame: Baseline, 3 months, 12 months
Change in health-related quality of life assessed by the SF-36
Time frame: Baseline, 3 months, 12 months
Change in self-reported daily sedentary time (min/day)
Time frame: Baseline, 3 months, 6 months and 12 months
Change in self-reported daily light-intensity physical activity (min/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Change in self-reported daily moderate-to-vigorous physical activity (min/day)
Time frame: Baseline, 3 months, 6 months, 12 months.
Attendance at behavioural counselling sessions (%)
Time frame: During the intervention period (0-6 months).
Attendance at supervised cardiac rehabilitation exercise sessions (%)
Time frame: During the 12-month study period (0-12 months).
Delivery of scheduled digital prompts (%)
Time frame: During the intervention period (0-6 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 23512568Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Background: PubMed 31794961Dempsey PC, Matthews CE, Dashti SG, Doherty AR, Bergouignan A, van Roekel EH, Dunstan DW, Wareham NJ, Yates TE, Wijndaele K, Lynch BM. Sedentary Behavior and Chronic Disease: Mechanisms and Future Directions. J Phys Act Health. 2020 Jan 1;17(1):52-61. doi: 10.1123/jpah.2019-0377.
- Background: PubMed 34017139Dunstan DW, Dogra S, Carter SE, Owen N. Sit less and move more for cardiovascular health: emerging insights and opportunities. Nat Rev Cardiol. 2021 Sep;18(9):637-648. doi: 10.1038/s41569-021-00547-y. Epub 2021 May 20.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Background: PubMed 33611446Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Cardiac Rehabilitation Care, Tailored behavioural counselling and Digital prompts in people with Cardiovascular Diseases (CVD) and Coronary Disease, run by University of Lisbon at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Durão Borges, PhD student (+351912328080, marianaborges1@edu.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily sedentary time (h/day) (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910812, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.