Cardiovascular Diseases (CVD)ACTIVE-CaReNCT07878520
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
A study testing aktivplan in people with Cardiovascular Diseases (CVD), run by Salzburg Research Forschungsgesellschaft mbH at 1 site in Austria.
Trial summary
After a cardiac event like a heart attack or heart surgery, regular heart-healthy exercise is important to reduce the risk of further cardiac events and improve quality of life. That is why patients are offered exercise-based cardiac rehabilitation programmes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases (CVD)
- What is being tested?
- aktivplan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2027to 28 Feb 2029
- 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
- Participation at one of the study centres in a phase II cardiac rehabilitation programme
- Ownership and use of a smartphone compatible with the aktivplan digital intervention (at least Android 5.0 or Apple iOS 13.0) with existing internet access - Willingness to attend the study centre for follow-up study visits
- Written informed consent from the patient
Who cannot join
- Patient's use of a digital intervention to support regular heart-healthy exercise already established in routine care
- Medical contraindications to ergometry
- Medical contraindications to regular heart-healthy exercise or cardiac exercise
- Medical contraindications to smartphone use
- Inability to engage in cardiovascular training (e.g., due to severe musculoskeletal impairment)
- Patient participation in another clinical trial within the last 6 months
Show all 10Show fewer
- Lack of mental capacity to consent to study participation
- Pregnancy or planned pregnancy during the study period
- Breastfeeding women with medical contraindications to physical activity and exercise
- Indications that the patient is unlikely to comply with the study protocol (e.g., unable to travel to follow-up study visits)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Salzburg Research Forschungsgesellschaft mbH
Salzburg, State of Salzburg, 2050
About this study
Official title: Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: A Crossover Randomised Controlled Trial
After a cardiac event like a heart attack or heart surgery, regular heart-healthy exercise is important to reduce the risk of further cardiac events and improve quality of life. That is why patients are offered exercise-based cardiac rehabilitation programmes. In these programmes, patients learn under medical supervision how to safely exercise after the cardiac event. The idea is that, after completion of the programme, patients should then independently continue to regularly exercise during their everyday lives.
But we know that many patients struggle to make heart-healthy exercise a habit during their everyday lives, even after completion of an exercise-based cardiac rehabilitation programme. Digital tools such as smartphone apps could be an option to help patients establish regular heart-healthy exercise in the long term.
Read more
aktvplan is a digital tool that has been developed in Austria specifically for this purpose. We are now conducting a study to find out whether aktivplan does in fact help patient to regularly exercise in the long term after an exercise-based cardiac rehabilitation programme.
aktivplan is an exercise scheduling app. At the end of the cardiac rehabilitation programme, the patient and the therapist discuss and agree on a suitable, personalised long-term exercise plan. The therapist then enters this exercise plan in the aktivplan app. The patient can view their personalised plan on the smartphone and check off completed exercise session. They also receive reminders and motivating messages to their smartphone. The therapist can see how many of the planned sessions the patient has completed. Should the patient struggle to complete the planned sessions, the therapist can contact the patient, discuss the reasons and possibly adapt the plan.
In this study, 68 patients will be included at several cardiac rehabilitation centres in Austria. They will be part of the study for 12 months after completing the cardiac rehabilitation programme. They will be randomly divided into two groups. "Randomly" means that the decision is by chance, like tossing a coin. The first group will receive aktivplan for six months after completing the cardiac rehabilitation programme, and then they will not have aktivplan for the remaining six months in the study. The second group will be opposite, so they will not have aktivplan for the first six months and then receive aktivplan for the second six months.
At the beginning, after six months and after 12 months, all patients will complete medical tests (exercise test, ultrasound of the heart, blood tests), measurements of their physical activity in everyday life (wearable sensor) and questionnaires (quality of life, self-confidence, anxiety). We will do statistical tests to compare how physically active and how physically fit the two study groups were at each of these time points. From this, we will be able to see whether aktivplan did in fact help these patients to regularly exercise in the long term.
- Conditions
- Cardiovascular Diseases (CVD)
- Being tested
- aktivplan
- Keywords
- Physical Activity, Exercise, Habit Formation, Secondary Prevention, Digital Health, Mobile Health, Lifestyle Modification, Cardiac Rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aktivplanDevice
The experimental intervention is the aktivplan digital health intervention. The intervention is based on a robust theoretical logic model and incorporates 12 evidence-based behaviour change strategies to supports the implementation of personalised exercise prescription and shared decision-making in cardiovascular rehabilitation according to current best-practice guidelines.
The aktivplan digital health intervention consists of a digital planning calendar for regular heart-healthy physical activity in combination with individual physical activity counselling and ongoing support by an exercise specialist such as a physiotherapist or sports scientist. Patients access the digital calendar via the aktivplan smartphone app, and exercise specialists access the digital calendar via the aktivplan website.
| Study group | Role | What they receive |
|---|---|---|
| AB | Other | Participants allocated to the AB arm will receive the intervention for the first 6 months and standard care for the second 2 months. Receives: Device: aktivplan |
| BA | Other | Participants allocated to the BA arm will receive standard care for the first 6 months and the intervention for the second 2 months. Receives: Device: aktivplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily minutes of moderate to vigorous physical activity (MVPA) measured objectively by a validated wrist-worn wearable device (ActiGraph LEAP Pro) for accelerometry and heart rate measurements over a 14-day period
Measured: At baseline, prior to the 6-months crossover timepoint, and at 12 months
Maximal exercise capacity (Watts) measured by maximal cycle ergometry
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Secondary outcomes (10)
Health-related quality of life measured with the EuroQol health-related quality of life questionnaire (EQ-5D-5L, interviewer-administered)
Measured: At baseline and at 3, 6, 9, and 12 months
Exercise self-efficacy measured with the Exercise Self-Efficacy Scale questionnaire (ESES, interviewer-administered)
Measured: At baseline and at 3, 6, 9, and 12 months
Depression and anxiety measured with the Patient Health Questionnaire-4 (PHQ-4, interviewer-administered)
Measured: At baseline and at 3, 6, 9, and 12 months
Kinesiophobia measured with 2 items adapted from the Tampa Kinesiophobia Scale questionnaire (TKS, interviewer-administered)
Measured: At baseline and at 3, 6, 9, and 12 months
Body mass index (kg/m2) derived from clinician-measured body weight (kg) and height (cm)
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Systolic and diastolic blood pressure (mmHg, clinician-measured)
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Blood levels of low-density lipoprotein cholesterol (LDL-C, mg/dL)
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Blood levels of glycated haemoglobin (HbA1c, %)
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Smoking status (self-report)
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Left-ventricular ejection fraction (%) measured by transthoracic echocardiogramm
Measured: At baseline, at the 6-months crossover timepoint, and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salzburg Research Forschungsgesellschaft mbH
- Sponsor type
- University, hospital or other
- Collaborators
- Reha-Zentrum Saalfelden, Ludwig Boltzmann Institute for Rehabilitation Research, Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Reha Zentrum Münster
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878520
- Sponsor's protocol ID
- A50/25
- Other IDs
- KLP4838625
- Acronym
- ACTIVE-CaRe
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For all scientific publications from this study, the IPD underpinning each publication will be anonymised and shared according to FAIR principles and with a persistend identifier (DOI) via the Open Science Framework platform.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: A Crossover Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07878520
- Acronym / sponsor ID
- ACTIVE-CaRe / A50/25
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- Physical Activity, Exercise, Habit Formation, Secondary Prevention, Digital Health, Mobile Health, Lifestyle Modification, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Salzburg Research Forschungsgesellschaft mbHUniversity, hospital or other
- Collaborators
- Reha-Zentrum Saalfelden, Ludwig Boltzmann Institute for Rehabilitation Research, Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Reha Zentrum Münster
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 16 Oct 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.
After a cardiac event like a heart attack or heart surgery, regular heart-healthy exercise is important to reduce the risk of further cardiac events and improve quality of life. That is why patients are offered exercise-based cardiac rehabilitation programmes. In these programmes, patients learn under medical supervision how to safely exercise after the cardiac event. The idea is that, after completion of the programme, patients should then independently continue to regularly exercise during their everyday lives.
But we know that many patients struggle to make heart-healthy exercise a habit during their everyday lives, even after completion of an exercise-based cardiac rehabilitation programme. Digital tools such as smartphone apps could be an option to help patients establish regular heart-healthy exercise in the long term.
aktvplan is a digital tool that has been developed in Austria specifically for this purpose. We are now conducting a study to find out whether aktivplan does in fact help patient to regularly exercise in the long term after an exercise-based cardiac rehabilitation programme.
aktivplan is an exercise scheduling app. At the end of the cardiac rehabilitation programme, the patient and the therapist discuss and agree on a suitable, personalised long-term exercise plan. The therapist then enters this exercise plan in the aktivplan app. The patient can view their personalised plan on the smartphone and check off completed exercise session. They also receive reminders and motivating messages to their smartphone. The therapist can see how many of the planned sessions the patient has completed. Should the patient struggle to complete the planned sessions, the therapist can contact the patient, discuss the reasons and possibly adapt the plan.
In this study, 68 patients will be included at several cardiac rehabilitation centres in Austria. They will be part of the study for 12 months after completing the cardiac rehabilitation programme. They will be randomly divided into two groups. "Randomly" means that the decision is by chance, like tossing a coin. The first group will receive aktivplan for six months after completing the cardiac rehabilitation programme, and then they will not have aktivplan for the remaining six months in the study. The second group will be opposite, so they will not have aktivplan for the first six months and then receive aktivplan for the second six months.
At the beginning, after six months and after 12 months, all patients will complete medical tests (exercise test, ultrasound of the heart, blood tests), measurements of their physical activity in everyday life (wearable sensor) and questionnaires (quality of life, self-confidence, anxiety). We will do statistical tests to compare how physically active and how physically fit the two study groups were at each of these time points. From this, we will be able to see whether aktivplan did in fact help these patients to regularly exercise in the long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB | Other | Device: aktivplanParticipants allocated to the AB arm will receive the intervention for the first 6 months and standard care for the second 2 months. |
| BA | Other | Device: aktivplanParticipants allocated to the BA arm will receive standard care for the first 6 months and the intervention for the second 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation at one of the study centres in a phase II cardiac rehabilitation programme
- Ownership and use of a smartphone compatible with the aktivplan digital intervention (at least Android 5.0 or Apple iOS 13.0) with existing internet access - Willingness to attend the study centre for follow-up study visits
- Written informed consent from the patient
Key exclusion criteria (10 listed)
- Patient's use of a digital intervention to support regular heart-healthy exercise already established in routine care
- Medical contraindications to ergometry
- Medical contraindications to regular heart-healthy exercise or cardiac exercise
- Medical contraindications to smartphone use
- Inability to engage in cardiovascular training (e.g., due to severe musculoskeletal impairment)
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 |
|---|---|---|
| aktivplanThe experimental intervention is the aktivplan digital health intervention. The intervention is based on a robust theoretical logic model and incorporates 12 evidence-based behaviour change strategies to supports the implementation of personalised exercise prescription and shared decision-making in cardiovascular rehabilitation according to current best-practice guidelines. The aktivplan digital health intervention consists of a digital planning calendar for regular heart-healthy physical activity in combination with individual physical activity counselling and ongoing support by an exercise specialist such as a physiotherapist or sports scientist. Patients access the digital calendar via the aktivplan smartphone app, and exercise specialists access the digital calendar via the aktivplan website. | Device | AB, BA |
Primary outcome
Daily minutes of moderate to vigorous physical activity (MVPA) measured objectively by a validated wrist-worn wearable device (ActiGraph LEAP Pro) for accelerometry and heart rate measurements over a 14-day period
Time frame: At baseline, prior to the 6-months crossover timepoint, and at 12 months
Maximal exercise capacity (Watts) measured by maximal cycle ergometry
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
10 secondary outcomes
Health-related quality of life measured with the EuroQol health-related quality of life questionnaire (EQ-5D-5L, interviewer-administered)
Time frame: At baseline and at 3, 6, 9, and 12 months
Exercise self-efficacy measured with the Exercise Self-Efficacy Scale questionnaire (ESES, interviewer-administered)
Time frame: At baseline and at 3, 6, 9, and 12 months
Depression and anxiety measured with the Patient Health Questionnaire-4 (PHQ-4, interviewer-administered)
Time frame: At baseline and at 3, 6, 9, and 12 months
Kinesiophobia measured with 2 items adapted from the Tampa Kinesiophobia Scale questionnaire (TKS, interviewer-administered)
Time frame: At baseline and at 3, 6, 9, and 12 months
Body mass index (kg/m2) derived from clinician-measured body weight (kg) and height (cm)
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
Systolic and diastolic blood pressure (mmHg, clinician-measured)
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
Blood levels of low-density lipoprotein cholesterol (LDL-C, mg/dL)
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
Blood levels of glycated haemoglobin (HbA1c, %)
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
Smoking status (self-report)
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 months
Left-ventricular ejection fraction (%) measured by transthoracic echocardiogramm
Time frame: At baseline, at the 6-months crossover timepoint, and at 12 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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. For all scientific publications from this study, the IPD underpinning each publication will be anonymised and shared according to FAIR principles and with a persistend identifier (DOI) via the Open Science Framework platform.
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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 aktivplan in people with Cardiovascular Diseases (CVD), run by Salzburg Research Forschungsgesellschaft mbH at 1 site in Austria.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Oct 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 Austria. 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 Stefan T Kulnik, PhD MRes (+43 (0) 662 2288-331, stefan.kulnik@salzburgresearch.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily minutes of moderate to vigorous physical activity (MVPA) measured objectively by a validated wrist-worn wearable device (ActiGraph LEAP Pro) for accelerometry and heart rate measurements over a 14-day period (time frame: At baseline, prior to the 6-months crossover timepoint, and at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.