Cardiac RehabilitationNCT06025526
Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)
A study testing aktivplan in people with Cardiac Rehabilitation and Secondary Prevention, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 2 sites in Austria.
Trial summary
The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Secondary Prevention, Cardiovascular Diseases
- What is being tested?
- aktivplan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesAustria
- Study dates
- 2 Oct 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
- Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
- Agreement to attend the study follow-up visit
- Written informed consent to take part in the study
Who cannot join
- Existing use of a digital intervention for regular heart-healthy physical activity
- Medical contraindications for incremental cycle ergometry test
- Medical contraindications for regular heart-healthy physical activity and sports
- Medical contraindications for use of a smartphone
- Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
- Participation in another clinical study within the past 6 months
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- Addiction or other medical conditions causing reduced decisional capacity
- Pregnant women in the third trimester
- Pregnant women in the first and second trimester with medical contraindication for physical activity and sports
- Breastfeeding women with medical contraindication for physical activity and sports
- Indication that patient is unlikely to follow study procedures (limited cooperation)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
REHA Zentrum Salzburg
Salzburg, State of Salzburg, 5020
Reha-Klinik Montafon
Schruns, Vorarlberg, 6780
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 Clinical Pilot Study
The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients.
The main questions this study aims to answer are:
Read more
- Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention?
- What is the usability, user experience and user acceptance of the aktivplan digital intervention?
Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation.
Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions.
Patients in the control group will receive the usual standard of care without the aktivplan digital intervention.
Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.
- Being tested
- aktivplan, Usual care
- Keywords
- Digital Health, Mobile Health, Electronic health, Smartphone App
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aktivplanOther
The aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation.
In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions.
Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app.
Usual careOther
Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: aktivplan |
| Control | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of recruits per week
Measured: 10 weeks
Drop-out rate
Number of drop-outs in at the 10-week follow-up visit
Measured: 10 weeks
Data completeness
Percentage of missing data fields in the study database
Measured: 10 weeks
Adherence to the aktivplan digital intervention
Automated usage logging of the aktivplan mobile application (Matomo platform)
Measured: 10 weeks
Usability of the aktivplan digital intervention
mHealth App Usability Questionnaire (MAUQ)
Measured: 10 weeks
User experience of the aktivplan digital intervention
AttrakDiff Short Questionnaire
Measured: 10 weeks
User acceptance of the aktivplan digital intervention
Mobile Application Rating Scale (MARS)
Measured: 10 weeks
Technical stability of the aktivplan digital intervention
Number and types of technical problems (qualitative data)
Measured: 10 weeks
Use of alternative and additional strategies for supporting physical activity
Number and types of additional strategies (qualitative data)
Measured: 10 weeks
Experiences and perspectives of patients regarding their study participation
Qualitative data from semi-structured interviews
Measured: 10 weeks
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
Qualitative data from focus groups
Measured: 10 weeks
Secondary outcomes (10)
Exercise capacity
Incremental cycle ergometry test
Measured: 10 weeks
Physical activity behaviour
Moderate to vigorous physical activity (MVPA)
Measured: 10 weeks
Weight
Weight in kg
Measured: 10 weeks
Blood pressure
Blood pressure in mmHg
Measured: 10 weeks
Blood cholesterol
Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio
Measured: 10 weeks
HbA1c
HbA1c level
Measured: 10 weeks
Smoking
Number and type of smoking products per week (qualitative data)
Measured: 10 weeks
Health-related quality of life
EQ-5D-5L Questionnaire
Measured: 10 weeks
Exercise self-efficacy
Exercise Self-Efficacy Scale (ESES)
Measured: 10 weeks
Patient safety
Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start2 Oct 2023
- Primary completion29 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- REHA Zentrum Salzburg, Reha-Klinik Montafon
- Responsible party
- Sponsor
- Investigators
- Stefan T Kulnik, PhD MRes, Study chair, Ludwig Boltzmann Institute for Digital Health and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025526
- Sponsor's protocol ID
- 23_5 ACTIVE-CaRe Pilot
- Status last verified
- Oct 2024
- First submitted
- 23 Aug 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leysen D, Wurhofer D, Hoppchen I, Bamberger EM, Breda A, Carrozzo AE, Crutzen R, Danner R, Duca I, Grote V, Kumar D, Leitner V, Mayr B, McGowan H, Niebauer J, Pfannerstill F, Reich B, Sareban M, Smeddinck JD, Treff G, Kulnik ST. Feasibility of the Aktivplan Digital Health Intervention for Supporting Regular Physical Activity Following Phase II Rehabilitation: Randomized Controlled Pilot Feasibility Study (ACTIVE-CaRe Pilot). JMIR Form Res. 2026 Aug 11;10:e90203. doi: 10.2196/90203.
PubMed 42610731Leysen D, Reich B, Carrozzo AE, Crutzen R, Grote V, Kumar D, Mayr B, Niebauer J, Pfannerstill F, Propst EM, Wurhofer D, Sareban M, Smeddinck JD, Treff G, Kulnik ST. Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot). JMIR Res Protoc. 2025 Sep 15;14:e73704. doi: 10.2196/73704.
PubMed 40953438
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. 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 Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06025526
- Acronym / sponsor ID
- 23_5 ACTIVE-CaRe Pilot
- Keywords
- Digital Health, Mobile Health, Electronic health, Smartphone App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Collaborators
- REHA Zentrum Salzburg, Reha-Klinik Montafon
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Sep 2023 (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.
The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients.
The main questions this study aims to answer are:
- Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention?
- What is the usability, user experience and user acceptance of the aktivplan digital intervention?
Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation.
Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions.
Patients in the control group will receive the usual standard of care without the aktivplan digital intervention.
Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: aktivplan |
| Control | Other | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
- Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
- Agreement to attend the study follow-up visit
- Written informed consent to take part in the study
Key exclusion criteria (11 listed)
- Existing use of a digital intervention for regular heart-healthy physical activity
- Medical contraindications for incremental cycle ergometry test
- Medical contraindications for regular heart-healthy physical activity and sports
- Medical contraindications for use of a smartphone
- Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
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 aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation. In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions. Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app. | Other | Intervention |
| Usual careUsual care (standard of care) according to international and national cardiac rehabilitation guidelines. | Other | Control |
Primary outcome
Recruitment rate
Time frame: 10 weeks
Number of recruits per week
Drop-out rate
Time frame: 10 weeks
Number of drop-outs in at the 10-week follow-up visit
Data completeness
Time frame: 10 weeks
Percentage of missing data fields in the study database
Adherence to the aktivplan digital intervention
Time frame: 10 weeks
Automated usage logging of the aktivplan mobile application (Matomo platform)
Usability of the aktivplan digital intervention
Time frame: 10 weeks
mHealth App Usability Questionnaire (MAUQ)
User experience of the aktivplan digital intervention
Time frame: 10 weeks
AttrakDiff Short Questionnaire
User acceptance of the aktivplan digital intervention
Time frame: 10 weeks
Mobile Application Rating Scale (MARS)
Technical stability of the aktivplan digital intervention
Time frame: 10 weeks
Number and types of technical problems (qualitative data)
Use of alternative and additional strategies for supporting physical activity
Time frame: 10 weeks
Number and types of additional strategies (qualitative data)
Experiences and perspectives of patients regarding their study participation
Time frame: 10 weeks
Qualitative data from semi-structured interviews
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
Time frame: 10 weeks
Qualitative data from focus groups
10 secondary outcomes
Exercise capacity
Time frame: 10 weeks
Physical activity behaviour
Time frame: 10 weeks
Weight
Time frame: 10 weeks
Blood pressure
Time frame: 10 weeks
Blood cholesterol
Time frame: 10 weeks
HbA1c
Time frame: 10 weeks
Smoking
Time frame: 10 weeks
Health-related quality of life
Time frame: 10 weeks
Exercise self-efficacy
Time frame: 10 weeks
Patient safety
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 42610731Leysen D, Wurhofer D, Hoppchen I, Bamberger EM, Breda A, Carrozzo AE, Crutzen R, Danner R, Duca I, Grote V, Kumar D, Leitner V, Mayr B, McGowan H, Niebauer J, Pfannerstill F, Reich B, Sareban M, Smeddinck JD, Treff G, Kulnik ST. Feasibility of the Aktivplan Digital Health Intervention for Supporting Regular Physical Activity Following Phase II Rehabilitation: Randomized Controlled Pilot Feasibility Study (ACTIVE-CaRe Pilot). JMIR Form Res. 2026 Aug 11;10:e90203. doi: 10.2196/90203.
- Derived from this study: PubMed 40953438Leysen D, Reich B, Carrozzo AE, Crutzen R, Grote V, Kumar D, Mayr B, Niebauer J, Pfannerstill F, Propst EM, Wurhofer D, Sareban M, Smeddinck JD, Treff G, Kulnik ST. Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot). JMIR Res Protoc. 2025 Sep 15;14:e73704. doi: 10.2196/73704.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stefan T Kulnik, PhD MRes study chair
Ludwig Boltzmann Institute for Digital Health and Prevention
2 sites 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 Cardiac Rehabilitation and Secondary Prevention, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 2 sites 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 10 weeks). The study lists 11 primary outcomes in all. 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 NCT06025526, which also lists 2 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 9 Oct 2024.