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Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The main goal for CR is to establish exercise training and other lifestyle changes as permanent changes in the patient's life. Many studies have shown that cardiac patients strive to maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this leads to risk profile returning to the starting point where they got their Cardiac event. Changing a lifestyle is known to take time, and we believe that the patients need further follow-up beyond the time spent in traditional CR.
To our knowledge very few, if any, studies evaluates the use of modern technology in longterm follow-up focusing on maintaining a new lifestyle after participating in CR. The investigators would like to evaluate the effect of an dynamic application (app) with regard to physical fitness, lifestyle and quality of life (QoL), one year after CR. The investigators hypothesize that patients getting Access to a dynamic Application and tailored feedback through the application after CR will better be able to take care of physical Fitness and other lifestyle factors one year after CR, compared to patients getting usal care.
Introduction:
Smartphones are widespread and in 2015 as much as 82% of the Norwegian population were owners of a smartphone. Recommendations has been pointed out in a new report from the Norwegian Board of Technology; health service should facilitate so that patients can follow up their health from home and simultaneously receive necessary help from the health service. The Norwegian Directorate of health points in a national action plan for e-health that evidence based digital tools in combination with an increase of competence will make it possible to reach health political goals such as quality levels, patient safety and an effective use of resources.
Across diseases adherence to treatment is one of the most important modifiable factors wich decreases the treatment effect. As much as 30-50% of patients do not adhere to recommended treatment. Adherence to treatment is complex and it depends on many factors; the patient, the patient surroundings (social support, the function of the health service, availability and resources) and characteristics with the disease and the corresponding treatment. World Health Organization (WHO) points to adherence to treatment as a global challenge and supports political decisions and research interventions that will increase adherence. Furthermore, adherence is considered to be a huge challenge in treatment for lifestyle changes such as smoking cessation, diet changes, training and physical activity. A meta-analysis (n=42 000) documented that "mixed mode of delivery interventions", where traditional techniques for behavior change was combined with digital tools, proved more effective than the use of traditional techniques for behavior change alone. Another meta-analysis (n=20 000) confirms this conclusion; therapy, guidance and conversation has an increased effect when it is used together with dedicated digital tools (6).
Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality and modifiable risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The main goal for CR is to establish exercise training and other lifestyle changes as permanent changes in the patient's life. Many studies have shown that cardiac patients do not reach the therapeutic goals regarding secondary prophylaxis one year after participating in CR. In other words; patients are not able to maintain the new lifestyle after CR and their risk profile goes back to base. Changing a lifestyle is known to take time, and we believe that the patients need further follow-up beyond the time spent in traditional CR.
To our knowledge very few studies, if any, evaluates the use of modern technology aiming to help the patients to maintain a new lifestyle after participating in CR. The investigators would therefore like to implement a randomized clinical trial (RCT) to evaluate the effect of the dynamic Application Vett® With regard to physical Fitness (peak oxygen uptake), one year after CR.
Method:
This study will provide New knowledge about the use of modern Technology with an Smartphone-Application in the follow-up of Cardiac patients. If the Application proves to be effective, this study will give clinicians a digital and evidence based tool for longterm follow-up of patients where changing lifestyle is the primary treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone-Application | Experimental | Patients in "Smartphone-Application"-arm will get Access to the Application Vett, they will be learned how to use it. They will receive feedback based on their goals and tasks in the Application for one year, and they will also receive motivational Notifications through the Application, atleast once a week in the follow-up period. Patients in this arm will also have the possibility to send questions to their supervisor through the Application, in that case they will receive answer within two working days. In addition they will receive usual care which is described below. |
|
| Control-group | No Intervention | Patients in the control-group will receive usual care consisting of general advice according to a heart-friendly lifestyle and follow-up by their general practitioner. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-Application | Device | Longterm follow-up after Cardiac rehabilitation With an Smartphone-Application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal oxygen consumption | Physical capacity will be evaluated With maximal oxygen consumption. We will do a cardiorespiratory Fitness test on a treadmill With a standardized ramp-protocol and Direct measurement of oxygen consumption | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Heart-Quality of Life (HeartQoL) will be used to assess quality of life. This is a disease specific questionnaire where you get an score between 0-3 (0 representing bad quality of life and 3 representing good quality of life). It consist of 14 question and you can get an emotional subscale and a physical subscale, aswell as a global scale. | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chang in Blood pressure | Systolic and diastolic blood pressure, measured manually in resting sitting position before treadmill test | Change from baseline to 12 months |
| Change in Exercise habits | The patients will be asked weekly exercise for the last year. Defined exercise as "at least 30 minutes of exercise With moderate to high intensity where you get sweaty and breathless" |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LHL-Feiring | Feiring | Norway | ||||
| NIMI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39946716 | Derived | Lunde P, Bye A, Grimsmo J, Pripp AH, Ritschel V, Jarstad E, Nilsson BB. Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial. J Med Internet Res. 2025 Feb 13;27:e60256. doi: 10.2196/60256. | |
| 31768261 | Derived | Lunde P, Bye A, Bergland A, Nilsson BB. Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial. BMC Sports Sci Med Rehabil. 2019 Nov 21;11:34. doi: 10.1186/s13102-019-0148-2. eCollection 2019. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Randomization to two different arms, intervention- or control-group
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The cardiologist, physical therapist and the physiologist at NIMI and Feiring will be masked.
| Change in Quality of Life | Euro Quality of life questionnaire (EQ-5D) | Change from baseline to 12 months |
| Change in Health Literacy | European Health Literacy Survey questionnaire (HLS-EU-Q47) | Change from baseline to 12 months |
| Type D personality | Standard assessment of Negative Affectivity, Social Inhibition, and Type D personality (DS14). | Baseline |
| Change in Endurance Fitness | Time to exhaution, incline and speed at the treadmill test. | Change from baseline to 12 months |
| Change from baseline to 12 months |
| Oslo |
| Norway |