An interventional study of aktivplan in Cardiovascular Diseases (CVD), sponsored by Salzburg Research Forschungsgesellschaft mbH. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Salzburg Research Forschungsgesellschaft mbH · Not applicable, Interventional, and Treatment
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 68 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →This is the only study on the registry with Salzburg Research Forschungsgesellschaft mbH as lead sponsor.
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Exclusion Criteria:
Participants allocated to the AB arm will receive the intervention for the first 6 months and standard care for the second 2 months.
Device: aktivplan
Participants allocated to the BA arm will receive standard care for the first 6 months and the intervention for the second 2 months.
Device: aktivplan
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.
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
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
Plan to share: 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
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