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The aim of this trial is to determine if a mobile application that promotes physical exercise in the follow-up of patients recently hospitalized with acute heart failure can improve exercise capacity after 6 months and physical activity levels compared to the standard follow-up.
A randomized clinical trial will be conducted with 100 consecutive patients aged +18 years, hospitalized for acute decompensated heart failure in a tertiary referral hospital who own a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data. At discharge, patients will be randomly assigned in two groups; the intervention group will be followed with a smartphone application to promote physical activity, whereas the control group will take responsibility in their adherence to exercise recommendations. Main study variables will be functional capacity after 6 months, which will be evaluated using the six minute walking test, and physical activity levels, using the International Physical Activity Questionnaire (IPAQ). The study will be analyzed using the intention-to-treat principle. The project has been authorized by the local committee for ethics in clinical research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health Arm | Experimental |
| |
| Control Arm | No Intervention | The Control Arm will receive standard of care including tailored prescription of physical activity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Intervention | Behavioral | The Mobile Health Arm will receive standard of care including tailored prescription of physical activity as well as the mobile health intervention, which will have the following features:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walking distance (6MWD) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ) | Results will be reported in categories (low activity levels, moderate activity levels or high activity levels) and as a continuous variable (MET minutes a week) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength - measured using the Medical Research Council (MRC) Sum Score | The total MRC sum score ranges from 0 (total paralysis) to 60 (normal strength). | 6 months |
| Upper limb strenght - measured by hand-held dynamometry |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Mirabet, Ph. D. | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
This instrument is scored using force production in kilograms (0-90)
| 6 months |
| Rectus femoris muscle diameter | 6 months |
| Physical function measured by the Short Physical Performance Battery score | Each task is scored from 0 to 4, with 4 being the best, and a total battery score of 12 points | 6 months |
| Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ) | Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life | 6 months |
| NT-proBNP levels | 6 months |
| Readmission rate for Heart Failure | 6 months |
| Participant reported time dedicated to exercise recommendations | 6 months |
| Number of steps -measured using the built-in smartphone pedometer | 6 months |
| User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial | 6 months |